Axial Spondyloarthritis, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,
Interventions
Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.
Sponsors
Study design
Eligibility
Inclusion criteria
* Confirmed diagnosis of RA, axSpA, PsA or PsO * No prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics.
Exclusion criteria
* The contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply. * The additional documentation of the patient in another post-marketing study with etanercept is not permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks | Week 12 up to Week 52 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 | Week 24 | DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1. |
| Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | Week 24 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS. |
| Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of Clear or Almost Clear and DLQI Total Score of 0 or 1 at Week 24 | Week 24 | PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect). |
| Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 | Week 12 | DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1. |
| Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 | Week 12 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS. |
| Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 | Week 12 | PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect). |
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks | Week 24 up to Week 52 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | Week 24 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | Week 12 | Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia). |
| Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Weeks 12, 24, 36, 52 | The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported. |
| Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Weeks 12, 24, 36, 52 | The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported. |
| Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Weeks 12, 24, 36, 52 | The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported. |
| Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Weeks 12, 24, 36, 52 | The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported. |
| Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Weeks 12, 24, 36, 52 | FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded). |
| Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Weeks 12, 24, 36, 52 | FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded). |
| Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Weeks 12, 24, 36, 52 | FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded). |
| Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events | Baseline up to Week 52 | Percentage of participants who discontinued etanercept before completing the study, was reported. |
| Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Baseline up to Week 52 | Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported. |
| Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 | Weeks 12, 24, 36, 52 | FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicated better daily activities. |
| Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. |
| Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms). |
| Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. |
| Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected. |
| Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Baseline, Weeks 12, 24, 36, 52 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. |
| Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) | Baseline up to Week 24 | PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline. |
| Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Weeks 12, 24, 36, 52 | PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). |
| Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Weeks 12, 24, 36, 52 | PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). |
| Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI \< 2; small effect at 2 \<=DLQI \<= 5; moderate effect at 6 \<=DLQI \<= 10; very large effect at 11\<=DLQI \<= 20; extremely large effect at 21 \<= DLQI \<= 30. |
| Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as no Pruritus to 100 as most severe pruritus. |
| Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort. |
| Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Baseline up to Weeks 12, 24, 36, 52 | — |
| Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Baseline up to Weeks 12, 24, 36, 52 | — |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | Baseline up to Weeks 12, 24, 36, 52 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs. |
| Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Baseline up to Weeks 12, 24, 36, 52 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs. |
| Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission. |
| Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Participants answered question: How do you assess your current disease activity? Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity. |
| Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. |
| Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). |
| Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. |
| Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 | Weeks 36, 52 | DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission. |
| Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of Clear or Almost Clear And DLQI Total Score of 0 or 1 at Weeks 36 and 52 | Weeks 36, 52 | PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect). |
| Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52 | Weeks 36, 52 | DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1. |
| Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 | Weeks 36, 52 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS. |
| Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) | Baseline | Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported. |
| Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured. |
| Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive. |
| C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months. | 1,465 |
| Total | 1,465 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinued prematurely | 410 |
| Overall Study | Documentation not completed | 255 |
| Overall Study | Excluded due to legal reasons | 8 |
| Overall Study | Not treated | 3 |
Baseline characteristics
| Characteristic | Etanercept | — |
|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 14.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 901 Participants | — |
| Sex: Female, Male Male | 564 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 1,465 |
| other Total, other adverse events | 606 / 1,465 |
| serious Total, serious adverse events | 151 / 1,465 |
Outcome results
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Time frame: Week 24
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | 28 Participants |
Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Time frame: Week 12
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 | 38 Participants |
Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of Clear or Almost Clear and DLQI Total Score of 0 or 1 at Week 24
PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time frame: Week 24
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of Clear or Almost Clear and DLQI Total Score of 0 or 1 at Week 24 | 11 Participants |
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24
DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1.
Time frame: Week 24
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 | 106 Participants |
Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
Time frame: Week 12
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 | 92 Participants |
Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1
PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time frame: Week 12
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 | 5 Participants |
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12
Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Week 12
Population: Per-protocol (PP) set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | 194 Participants |
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Week 12 up to Week 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks | 58 Participants |
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Week 24
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | 203 Participants |
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Week 24 up to Week 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks | 88 Participants |
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 12: FFbH vs. Morning stiffness | -0.523 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 24: FFbH vs. Morning stiffness | -0.523 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 36: FFbH vs. Morning stiffness | -0.565 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 52: FFbH vs. Morning stiffness | -0.600 spearman correlation coefficient |
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12:PtGA vs. Fatigue | 0.582 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. Pain | 0.899 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. PHQ-2 | 0.526 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. PGA | 0.606 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. Pain | 0.547 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. PHQ-2 | 0.487 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. PGA | 0.369 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Pain vs. PHQ-2 | 0.530 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Pain vs. PGA | 0.617 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PHQ-2 vs. PGA | 0.392 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. Fatigue | 0.668 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. Pain | 0.904 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. PHQ-2 | 0.495 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. PGA | 0.495 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. Pain | 0.664 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. PHQ-2 | 0.634 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. PGA | 0.445 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Pain vs. PHQ-2 | 0.492 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Pain vs. PGA | 0.515 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PHQ-2 vs. PGA | 0.449 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. Fatigue | 0.720 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. Pain | 0.914 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. PHQ-2 | 0.630 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. PGA | 0.586 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. Pain | 0.728 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. PHQ-2 | 0.691 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. PGA | 0.530 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Pain vs. PHQ-2 | 0.637 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Pain vs. PGA | 0.591 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PHQ-2 vs. PGA | 0.483 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. Fatigue | 0.717 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. Pain | 0.912 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. PHQ-2 | 0.586 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. PGA | 0.548 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. Pain | 0.743 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. PHQ-2 | 0.676 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. PGA | 0.457 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Pain vs. PHQ-2 | 0.629 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Pain vs. PGA | 0.603 spearman correlation coefficient |
| Etanercept | Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PHQ-2 vs. PGA | 0.420 spearman correlation coefficient |
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52
BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Week 12 | 3.8 units on a scale | Standard Deviation 2.3 |
| Etanercept | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Week 24 | 3.5 units on a scale | Standard Deviation 2.3 |
| Etanercept | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Week 36 | 3.2 units on a scale | Standard Deviation 2.1 |
| Etanercept | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Week 52 | 3.3 units on a scale | Standard Deviation 2.2 |
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Time frame: Baseline, Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Baseline | 16.8 units on a scale | Standard Deviation 10.1 |
| Etanercept | Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Change at Week 12 | -9.6 units on a scale | Standard Deviation 10.3 |
| Etanercept | Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Change at Week 24 | -13.0 units on a scale | Standard Deviation 10.6 |
| Etanercept | Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Change at Week 36 | -14.4 units on a scale | Standard Deviation 10.9 |
| Etanercept | Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Change at Week 52 | -14.8 units on a scale | Standard Deviation 11 |
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Week 12 | 12.7 units on a scale | Standard Deviation 9.7 |
| Etanercept | Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Week 24 | 11.0 units on a scale | Standard Deviation 9.4 |
| Etanercept | Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Week 36 | 10.1 units on a scale | Standard Deviation 8.9 |
| Etanercept | Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Week 52 | 9.2 units on a scale | Standard Deviation 9.1 |
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI \< 2; small effect at 2 \<=DLQI \<= 5; moderate effect at 6 \<=DLQI \<= 10; very large effect at 11\<=DLQI \<= 20; extremely large effect at 21 \<= DLQI \<= 30.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Week 12 | 8.3 units on a scale | Standard Deviation 7.4 |
| Etanercept | Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Week 24 | 5.5 units on a scale | Standard Deviation 5.8 |
| Etanercept | Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Week 36 | 4.8 units on a scale | Standard Deviation 5.5 |
| Etanercept | Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Week 52 | 3.7 units on a scale | Standard Deviation 4.6 |
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52
FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicated better daily activities.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, axSpA or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 | Week 12 | 71.4 units on a scale | Standard Deviation 22.2 |
| Etanercept | Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 | Week 24 | 72.2 units on a scale | Standard Deviation 22.4 |
| Etanercept | Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 | Week 36 | 73.4 units on a scale | Standard Deviation 22.3 |
| Etanercept | Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 | Week 52 | 73.7 units on a scale | Standard Deviation 22.5 |
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52
Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Week 12 | 1.4 finger or toes | Standard Deviation 2.1 |
| Etanercept | Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Week 24 | 0.7 finger or toes | Standard Deviation 1.3 |
| Etanercept | Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Week 36 | 0.7 finger or toes | Standard Deviation 1.4 |
| Etanercept | Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Week 52 | 0.6 finger or toes | Standard Deviation 1.3 |
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52
Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO, PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Week 12 | 8.5 percentage of BSA | Standard Deviation 12.8 |
| Etanercept | Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Week 24 | 5.9 percentage of BSA | Standard Deviation 9.2 |
| Etanercept | Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Week 36 | 4.8 percentage of BSA | Standard Deviation 7.1 |
| Etanercept | Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 | Week 52 | 5.4 percentage of BSA | Standard Deviation 10.9 |
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Week 12 | 40.9 mm | Standard Deviation 30.1 |
| Etanercept | Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Week 24 | 37.7 mm | Standard Deviation 29.5 |
| Etanercept | Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Week 36 | 36.1 mm | Standard Deviation 28.9 |
| Etanercept | Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Week 52 | 33.5 mm | Standard Deviation 27.8 |
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52
Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | Week 12 | 38.3 mm | Standard Deviation 26.9 |
| Etanercept | Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | Week 24 | 34.9 mm | Standard Deviation 26.3 |
| Etanercept | Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | Week 36 | 32.9 mm | Standard Deviation 25.6 |
| Etanercept | Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | Week 52 | 31.1 mm | Standard Deviation 24.7 |
Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO)
PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
Time frame: Baseline up to Week 24
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Etanercept | Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) | 100 days | Standard Deviation 85.6 |
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52
An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 | Week 12 | 1.0 enthesis | Standard Deviation 1.8 |
| Etanercept | Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 | Week 24 | 0.6 enthesis | Standard Deviation 1.2 |
| Etanercept | Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 | Week 36 | 0.4 enthesis | Standard Deviation 1.1 |
| Etanercept | Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 | Week 52 | 0.3 enthesis | Standard Deviation 1 |
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | Week 12 | 278 Participants |
| Etanercept | Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | Week 24 | 305 Participants |
| Etanercept | Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | Week 36 | 263 Participants |
| Etanercept | Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | Week 52 | 271 Participants |
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation
Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.
Time frame: Baseline up to Week 52
Population: Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. Overall number of participants analyzed signifies participants from treated set who discontinued treatment with Etanercept.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Abatacept | 15 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Adalimumab | 53 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Apremilast | 7 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Azathioprin | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Azathioprin, Leflunomid, Diclofenac | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Azathioprin, Prednisolon | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Baricitinib | 3 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Biological NOS | 5 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Certolizumab | 26 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Etanercept Biosimilar | 10 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Golimumab | 6 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Hydroxychloroquin | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Leflunomid | 4 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Methotrexate (MTX) | 6 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | MTX, Adalimumab | 2 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | MTX, Prednisolon | 3 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | MTX, Tocilizumab | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Prednisolon | 13 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Prednisolon, Diclofenac | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Remsima (Infliximab-Biosimilar) | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Rituximab | 12 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Roactemra | 10 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Secukinumab | 27 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Sulfasalazin | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Sulfasalazin, Leflunomid | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Tapentadol | 2 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Tocilizumab | 25 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Tofacitinib | 2 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Ustekinumab | 7 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Etoricoxib | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Ibuprofen | 2 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Ibuprofen, Metamizol | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Ibuprofen, Prednisolon, Oxycodon, Pregabalin | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Inflectra (Infliximab Biosimilar) | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Infliximab | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | NSAR | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Corticosteroid | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | PUVA | 1 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Unknown | 5 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | None | 56 Participants |
| Etanercept | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Missing values | 92 Participants |
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Time frame: Baseline up to Weeks 12, 24, 36, 52
Population: Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | Up to Week 12 | 417 Participants |
| Etanercept | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | Up to Week 24 | 567 Participants |
| Etanercept | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | Up to Week 36 | 651 Participants |
| Etanercept | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | Up to Week 52 | 699 Participants |
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Time frame: Baseline up to Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Up to Week 12 | 416 Participants |
| Etanercept | Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Up to Week 24 | 564 Participants |
| Etanercept | Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Up to Week 36 | 646 Participants |
| Etanercept | Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Up to Week 52 | 694 Participants |
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52
Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Week 12 | 6.7 cm | Standard Deviation 10.7 |
| Etanercept | Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Week 24 | 6.6 cm | Standard Deviation 11.3 |
| Etanercept | Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Week 36 | 6.3 cm | Standard Deviation 11.2 |
| Etanercept | Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 | Week 52 | 6.0 cm | Standard Deviation 11 |
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as no Pruritus to 100 as most severe pruritus.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Week 12 | 35.5 units on a scale | Standard Deviation 30.9 |
| Etanercept | Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Week 24 | 22.4 units on a scale | Standard Deviation 23.8 |
| Etanercept | Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Week 36 | 24.2 units on a scale | Standard Deviation 26.6 |
| Etanercept | Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Week 52 | 14.8 units on a scale | Standard Deviation 15.8 |
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52
Participants answered question: How do you assess your current disease activity? Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | Week 12 | 39.8 mm | Standard Deviation 24.9 |
| Etanercept | Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | Week 24 | 35.5 mm | Standard Deviation 25.1 |
| Etanercept | Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | Week 36 | 32.7 mm | Standard Deviation 23.8 |
| Etanercept | Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | Week 52 | 30.5 mm | Standard Deviation 23.3 |
Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52
The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 | Week 12 | 2.0 units on a scale | Standard Deviation 1.6 |
| Etanercept | Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 | Week 24 | 1.8 units on a scale | Standard Deviation 1.6 |
| Etanercept | Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 | Week 36 | 1.7 units on a scale | Standard Deviation 1.5 |
| Etanercept | Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 | Week 52 | 1.6 units on a scale | Standard Deviation 1.5 |
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set
Time frame: Baseline up to Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Up to Week 12 | 89.4 percentage of participants |
| Etanercept | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Up to Week 24 | 81.1 percentage of participants |
| Etanercept | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Up to Week 36 | 75.6 percentage of participants |
| Etanercept | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Up to Week 52 | 71.6 percentage of participants |
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS)
Time frame: Baseline up to Weeks 12, 24, 36, 52
Population: Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Up to Week 12 | 89.5 percentage of participants |
| Etanercept | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Up to Week 24 | 81.2 percentage of participants |
| Etanercept | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Up to Week 36 | 75.6 percentage of participants |
| Etanercept | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Up to Week 52 | 71.6 percentage of participants |
Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events
Percentage of participants who discontinued etanercept before completing the study, was reported.
Time frame: Baseline up to Week 52
Population: Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events | Due to lack of Efficacy | 15.2 percentage of participants |
| Etanercept | Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events | Due to Adverse Events | 8.5 percentage of participants |
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52
PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 | Week 12 | 32.5 mm | Standard Deviation 21.1 |
| Etanercept | Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 | Week 24 | 26.9 mm | Standard Deviation 20.5 |
| Etanercept | Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 | Week 36 | 23.8 mm | Standard Deviation 19.4 |
| Etanercept | Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 | Week 52 | 21.7 mm | Standard Deviation 18.9 |
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. Fatigue | 0.350 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. Pain | 0.606 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. PHQ-2 | 0.563 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. PGA | 0.606 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. Pain | 0.679 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. PHQ-2 | 0.681 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. PGA | 0.175 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Pain vs. PHQ-2 | 0.647 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Pain vs. PGA | 0.384 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PHQ-2 vs. PGA | 0.265 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. Fatigue | 0.651 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. Pain | 0.692 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. PHQ-2 | 0.485 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. PGA | 0.713 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. Pain | 0.802 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. PHQ-2 | 0.577 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. PGA | 0.377 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Pain vs. PHQ-2 | 0.466 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Pain vs. PGA | 0.470 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PHQ-2 vs. PGA | 0.219 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. Fatigue | 0.627 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. Pain | 0.687 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. PHQ-2 | 0.585 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. PGA | 0.519 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. Pain | 0.744 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. PHQ-2 | 0.812 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. PGA | 0.288 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Pain vs. PHQ-2 | 0.659 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Pain vs. PGA | 0.411 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PHQ-2 vs. PGA | 0.167 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. Fatigue | 0.418 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. Pain | 0.625 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. PHQ-2 | 0.464 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. PGA | 0.753 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. Pain | 0.579 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. PHQ-2 | 0.598 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. PGA | 0.278 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Pain vs. PHQ-2 | 0.404 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Pain vs. PGA | 0.421 spearman correlation coefficient |
| Etanercept | Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PHQ-2 vs. PGA | 0.208 spearman correlation coefficient |
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO)
PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 12, Head | 0.4 units on a scale | Standard Deviation 0.8 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 12: Trunk | 1.6 units on a scale | Standard Deviation 2 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 12: Upper extremities | 1.4 units on a scale | Standard Deviation 1.6 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 12: Lower extremities | 3.5 units on a scale | Standard Deviation 3.7 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 24: Head | 0.2 units on a scale | Standard Deviation 0.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 24: Trunk | 0.6 units on a scale | Standard Deviation 0.8 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 24: Upper extremities | 0.9 units on a scale | Standard Deviation 1 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 24: Lower extremities | 2.3 units on a scale | Standard Deviation 2.7 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 36: Head | 0.2 units on a scale | Standard Deviation 0.4 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 36: Trunk | 0.5 units on a scale | Standard Deviation 0.9 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 36: Upper extremities | 0.5 units on a scale | Standard Deviation 0.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 36: Lower extremities | 1.5 units on a scale | Standard Deviation 2 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 52: Head | 0.1 units on a scale | Standard Deviation 0.3 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 52: Trunk | 0.5 units on a scale | Standard Deviation 1 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 52: Upper extremities | 0.5 units on a scale | Standard Deviation 0.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | Week 52: Lower extremities | 1.4 units on a scale | Standard Deviation 1.9 |
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO)
PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 12, Erythema | 1.4 units on a scale | Standard Deviation 0.7 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 12: Induration | 1.2 units on a scale | Standard Deviation 0.7 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 12: Desquamation | 1.1 units on a scale | Standard Deviation 0.7 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 24: Erythema | 1.0 units on a scale | Standard Deviation 0.7 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 24: Induration | 0.9 units on a scale | Standard Deviation 0.6 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 24: Desquamation | 0.9 units on a scale | Standard Deviation 0.7 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 36: Erythema | 0.7 units on a scale | Standard Deviation 0.6 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 36: Induration | 0.6 units on a scale | Standard Deviation 0.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 36: Desquamation | 0.6 units on a scale | Standard Deviation 0.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 52: Erythema | 0.7 units on a scale | Standard Deviation 0.7 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 52: Induration | 0.5 units on a scale | Standard Deviation 0.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | Week 52: Desquamation | 0.6 units on a scale | Standard Deviation 0.6 |
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 12: FFbH vs. Morning stiffness | -0.493 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 24: FFbH vs. Morning stiffness | -0.640 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 36: FFbH vs. Morning stiffness | -0.615 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 52: FFbH vs. Morning stiffness | -0.560 spearman correlation coefficient |
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. Fatigue | 0.630 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. Pain | 0.892 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. PHQ-2 | 0.609 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. PGA | 0.509 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. Pain | 0.664 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. PHQ-2 | 0.601 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. PGA | 0.324 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Pain vs. PHQ-2 | 0.628 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Pain vs. PGA | 0.529 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PHQ-2 vs. PGA | 0.381 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. Fatigue | 0.656 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. Pain | 0.881 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. PHQ-2 | 0.562 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. PGA | 0.559 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. Pain | 0.674 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. PHQ-2 | 0.620 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. PGA | 0.374 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Pain vs. PHQ-2 | 0.607 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Pain vs. PGA | 0.630 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PHQ-2 vs. PGA | 0.410 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. Fatigue | 0.692 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. Pain | 0.913 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. PHQ-2 | 0.645 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. PGA | 0.513 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. Pain | 0.724 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. PHQ-2 | 0.710 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. PGA | 0.423 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Pain vs. PHQ-2 | 0.658 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Pain vs. PGA | 0.532 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PHQ-2 vs. PGA | 0.357 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. Fatigue | 0.753 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. Pain | 0.908 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. PHQ-2 | 0.696 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. PGA | 0.565 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. Pain | 0.760 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. PHQ-2 | 0.726 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. PGA | 0.430 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Pain vs. PHQ-2 | 0.683 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Pain vs. PGA | 0.581 spearman correlation coefficient |
| Etanercept | Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PHQ-2 vs. PGA | 0.498 spearman correlation coefficient |
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 12: FFbH vs. Morning stiffness | -0.439 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 24: FFbH vs. Morning stiffness | -0.486 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 36: FFbH vs. Morning stiffness | -0.520 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 | Week 52: FFbH vs. Morning stiffness | -0.502 spearman correlation coefficient |
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA versus (vs.) Fatigue | 0.514 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. Pain | 0.825 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. PHQ-2 | 0.450 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PtGA vs. PGA | 0.603 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. Pain | 0.586 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. PHQ-2 | 0.577 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Fatigue vs. PGA | 0.370 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Pain vs. PHQ-2 | 0.529 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: Pain vs. PGA | 0.612 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 12: PHQ-2 vs. PGA | 0.376 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. Fatigue | 0.588 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. Pain | 0.859 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. PHQ-2 | 0.526 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PtGA vs. PGA | 0.600 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. Pain | 0.621 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. PHQ-2 | 0.591 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Fatigue vs. PGA | 0.389 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Pain vs. PHQ-2 | 0.558 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: Pain vs. PGA | 0.556 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 24: PHQ-2 vs. PGA | 0.379 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. Fatigue | 0.664 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. Pain | 0.839 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. PHQ-2 | 0.513 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PtGA vs. PGA | 0.609 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. Pain | 0.646 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. PHQ-2 | 0.614 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Fatigue vs. PGA | 0.463 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Pain vs. PHQ-2 | 0.532 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: Pain vs. PGA | 0.576 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 36: PHQ-2 vs. PGA | 0.367 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. Fatigue | 0.666 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. Pain | 0.861 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. PHQ-2 | 0.507 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PtGA vs. PGA | 0.632 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. Pain | 0.649 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. PHQ-2 | 0.574 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Fatigue vs. PGA | 0.485 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Pain vs. PHQ-2 | 0.545 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: Pain vs. PGA | 0.641 spearman correlation coefficient |
| Etanercept | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 | Week 52: PHQ-2 vs. PGA | 0.445 spearman correlation coefficient |
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Week 12 | 14.3 units on a scale | Standard Deviation 11 |
| Etanercept | Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Week 24 | 12.0 units on a scale | Standard Deviation 11.3 |
| Etanercept | Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Week 36 | 11.1 units on a scale | Standard Deviation 9.7 |
| Etanercept | Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 | Week 52 | 10.1 units on a scale | Standard Deviation 10.2 |
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52
To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, AxS or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 | Week 12 | 236.2 unit per milliliter (U/mL) | Standard Deviation 695.7 |
| Etanercept | Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 | Week 24 | 202.2 unit per milliliter (U/mL) | Standard Deviation 615.6 |
| Etanercept | Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 | Week 36 | 178.6 unit per milliliter (U/mL) | Standard Deviation 635.3 |
| Etanercept | Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 | Week 52 | 176.2 unit per milliliter (U/mL) | Standard Deviation 714.4 |
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 | Week 12 | 10.9 mg/L | Standard Deviation 33.9 |
| Etanercept | C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 | Week 24 | 10.9 mg/L | Standard Deviation 37.4 |
| Etanercept | C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 | Week 36 | 10.2 mg/L | Standard Deviation 31.4 |
| Etanercept | C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 | Week 52 | 9.7 mg/L | Standard Deviation 30.3 |
Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. 'Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 | Week 36 | 18.4 mm/hr | Standard Deviation 17.4 |
| Etanercept | Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 | Week 12 | 19.7 mm/hr | Standard Deviation 18.4 |
| Etanercept | Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 | Week 24 | 19.4 mm/hr | Standard Deviation 18.8 |
| Etanercept | Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 | Week 52 | 18.2 mm/hr | Standard Deviation 17.6 |
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Time frame: Weeks 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 | Week 36 | 35 Participants |
| Etanercept | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 | Week 52 | 32 Participants |
Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of Clear or Almost Clear And DLQI Total Score of 0 or 1 at Weeks 36 and 52
PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time frame: Weeks 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of Clear or Almost Clear And DLQI Total Score of 0 or 1 at Weeks 36 and 52 | Week 36 | 13 Participants |
| Etanercept | Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of Clear or Almost Clear And DLQI Total Score of 0 or 1 at Weeks 36 and 52 | Week 52 | 14 Participants |
Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA)
Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.
Time frame: Baseline
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etanercept | Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) | 223 Participants |
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
Time frame: Weeks 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52 | Week 36 | 93 Participants |
| Etanercept | Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52 | Week 52 | 87 Participants |
Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission.
Time frame: Weeks 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 | Week 36 | 173 Participants |
| Etanercept | Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 | Week 52 | 187 Participants |
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52
RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.
Time frame: Weeks 12, 24, 36, 52
Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, axSpA or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etanercept | Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 | Week 12 | 310 Participants |
| Etanercept | Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 | Week 24 | 259 Participants |
| Etanercept | Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 | Week 36 | 208 Participants |
| Etanercept | Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 | Week 52 | 173 Participants |