Ankylosing Spondylitis
Conditions
Brief summary
Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period, we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing the efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100 mg/week) in subjects with AS refractory to conventional therapy. The interim results of said study do not appear to support the value of doubling the dose of etanercept in the treatment of subjects with AS. Once this study was finalised, the subjects continued to be monitored by their regular physician, who decided on the dose and treatment to follow according to the conditions of standard clinical practice. The objective of this observational study is to evaluate the course of the disease in the long-term (three years) under the conditions of standard clinical practice, in subjects who had participated in the LoadET study. Therefore, we would like to follow-up on those patients by reviewing their clinical histories for the three-year period between the finalisation of their participation in the LoadET Study (0881A3-102090) and now. This will allow us to assess the efficacy and survival of the drug, as well as the possible appearance of side effects in the three years following the finalisation of the study by comparing the results according to if the subjects had received 50 mg/week or 100 mg/week during the LoadET study (0881A3 102090).
Detailed description
Given that this is a follow-up study of subjects who participated in the LoadET study (0881A3-102090), we have planned the inclusion of all subjects who completed said study, that is, 97 of the 108 subjects in the LoadET study.
Interventions
DRUGETANERCEPT
During the LoadET study (0881A3-102090), subjects were treated with etanercept 100 mg versus 50 mg weekly. After completing this study, the subjects were allowed to continue the treatment with etanercept 50 mg weekly, etanercept 100 mg weekly, another drug, or abandoned medication at the discretion of their physician. This is a non-interventional study in which historic data will be collected retrospectively from the patient's clinical history. During the historical period covered in the Study, patients would have received the treatment and the medical care that their treating physicians considered appropriate under the conditions of standard clinical practice.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AS patients who had previously participated in the LoadET study (0881A3-102090). * Subjects who completed the LoadET Study. * Patients who grant their informed consent
Exclusion criteria
* Patients who participated in the LoadET study but who discontinued treatment and, therefore, did not complete the study. * Patients without standard follow-up by the physician since the end of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Discontinued Treatment With Etanercept | Baseline up to Year 3 | Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Diagnosis of Ankylosing Spondylitis | Baseline | Time to first diagnosis of alkylosing spondylitis was reported. |
| Number of Participants Who Received Non-pharmacological Treatment | Baseline up to Year 3 | Participants who received any non-pharmacological treatment (participant education, regular exercises and physical therapy) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported. |
| Number of Participants Who Received Pharmacological Treatment | Baseline up to Year 3 | Participants who received any pharmacological treatment (non-steroidal anti-inflammatory drugs \[NSAIDs\], disease-modifying antirheumatic drugs \[DMARDs\], corticosteroids and other treatments including anti-tumor necrosis factor-alpha \[TNFalpha\] or other biological agents etc.) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported. |
| Patient Global Assessment (PtGA) of Disease Activity Score | Baseline, Year 1, 2, 3 | Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad. |
| Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline, Year 1, 2, 3 | BASFI is a validated self-assessment tool that determines the degree of functional limitation in ankylosing spondylitis. Utilizing a VAS of 0-10, 0 = easy, 10 = impossible, participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions, final score ranged from 0-100, where higher score referred to higher impairment in the functional ability. |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline, Year 1, 2, 3 | 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 is a sum of the individual assessments. Final score ranged from 0-60, higher score indicates higher disease activity. |
| Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline, Year 1, 2, 3 | Participant's spinal pain - was assessed by answering question 2 of BASDAI on a 0 to10 VAS; participants were asked: How would you describe the overall level of ankylosing spondylitis neck, back or hip pain you have had? 0 =none and 10 =very severe. |
| Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist | Baseline | Time passed since the ankylosing spondylitis symptoms started until the participant arrived for the first time to visit the rheumatologist was reported. Ankylosing spondylitis symptoms may include pain, stiffness, axial manifestations, and enthesitis etc. |
| Modified Schober's Test | Baseline, Year 1, 2, 3 | Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured (in cm rounded to the nearest 0.1 cm) with participant maximally bend forward, knees fully extended, with spine in full flexion. The measurement of two attempts was made. |
| Occiput-to-wall Distance | Baseline, Year 1, 2, 3 | Occiput-to-wall distance: 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. The distance between the occiput and the wall was measured in cm (rounded to the nearest 0.1 cm), in two attempts. |
| Chest Expansion Measurement | Baseline, Year 1, 2, 3 | Chest expansion, measured in cm (rounded to the nearest 0.1 cm), is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation. The measurement of two attempts was made. |
| C-reactive Protein (CRP) | Baseline, Year 1, 2, 3 | 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. |
| Erythrocyte Sedimentation Rate (ESR) | Baseline, Year 1, 2, 3 | 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 millimeter/hour (mm/hr). A higher rate is consistent with inflammation. |
| Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Baseline, Year 1, 2, 3 | Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs). |
| Time to Treatment Discontinuation With Etanercept | Year 3 | Time to treatment discontinuation with etanercept was assessed retrospectively at Year 3 for participants who did not discontinue treatment at the end of previous LoadET study 0881A3-102090 (NCT00873730). It was defined as time from first dose of etanercept received in the previous LoadET study 0881A3-102090 (NCT00873730) to last dose of etanercept. |
| Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline, Year 1, 2, 3 | Participant's fatigue was assessed by answering question 1 of BASDAI on a 0 to 10 VAS; participants were asked: How would you describe the overall level of fatigue/tiredness you have experienced? 0=none and 10=very severe. |
Countries
Spain
Participant flow
Recruitment details
Participants who completed the LoadET study 0881A3-102090 (NCT00873730), were eligible for this study.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years. | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age Continuous | 45.90 years STANDARD_DEVIATION 10.67 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 85 |
| serious Total, serious adverse events | 2 / 85 |
Outcome results
Primary
Percentage of Participants Who Discontinued Treatment With Etanercept
Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes.
Time frame: Baseline up to Year 3
Population: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants Who Discontinued Treatment With Etanercept | 41.2 percentage of participants |
Secondary
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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 is a sum of the individual assessments. Final score ranged from 0-60, higher score indicates higher disease activity.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline (n=45) | 9.90 units on a scale |
| Etanercept | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 1 (n=34) | 10.60 units on a scale |
| Etanercept | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 2 (n=28) | 10.50 units on a scale |
| Etanercept | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 3 (n=48) | 9.30 units on a scale |
Secondary
Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is a validated self-assessment tool that determines the degree of functional limitation in ankylosing spondylitis. Utilizing a VAS of 0-10, 0 = easy, 10 = impossible, participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions, final score ranged from 0-100, where higher score referred to higher impairment in the functional ability.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline (n=45) | 26.00 units on a scale |
| Etanercept | Bath Ankylosing Spondylitis Functional Index (BASFI) | Year 1 (n=30) | 23.10 units on a scale |
| Etanercept | Bath Ankylosing Spondylitis Functional Index (BASFI) | Year 2 (n=25) | 23.00 units on a scale |
| Etanercept | Bath Ankylosing Spondylitis Functional Index (BASFI) | Year 3 (n=48) | 24.05 units on a scale |
Secondary
Chest Expansion Measurement
Chest expansion, measured in cm (rounded to the nearest 0.1 cm), is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation. The measurement of two attempts was made.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Chest Expansion Measurement | Baseline: Maximum Inspiration (n=39) | 98.00 cm |
| Etanercept | Chest Expansion Measurement | Baseline: Minimum Inspiration (n=32) | 98.13 cm |
| Etanercept | Chest Expansion Measurement | Year 1: Maximum Inspiration (n=5) | 96.25 cm |
| Etanercept | Chest Expansion Measurement | Year 1: Minimum Inspiration (n=5) | 101.00 cm |
| Etanercept | Chest Expansion Measurement | Year 2: Maximum Inspiration (n=6) | 100.50 cm |
| Etanercept | Chest Expansion Measurement | Year 2: Minimum Inspiration (n=7) | 86.00 cm |
| Etanercept | Chest Expansion Measurement | Year 3: Maximum Inspiration (n=36) | 96.75 cm |
| Etanercept | Chest Expansion Measurement | Year 3: Minimum Inspiration (n=32) | 94.38 cm |
Secondary
C-reactive Protein (CRP)
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: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | C-reactive Protein (CRP) | Baseline (n=45) | 0.27 milligram per milliliter (mg/mL) |
| Etanercept | C-reactive Protein (CRP) | Year 1 (n=46) | 0.25 milligram per milliliter (mg/mL) |
| Etanercept | C-reactive Protein (CRP) | Year 2 (n=47) | 0.47 milligram per milliliter (mg/mL) |
| Etanercept | C-reactive Protein (CRP) | Year 3 (n=49) | 0.40 milligram per milliliter (mg/mL) |
Secondary
Erythrocyte Sedimentation Rate (ESR)
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 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Erythrocyte Sedimentation Rate (ESR) | Baseline (n=50) | 2.00 mm/hr |
| Etanercept | Erythrocyte Sedimentation Rate (ESR) | Year 1 (n=44) | 4.00 mm/hr |
| Etanercept | Erythrocyte Sedimentation Rate (ESR) | Year 2 (n=49) | 4.00 mm/hr |
| Etanercept | Erythrocyte Sedimentation Rate (ESR) | Year 3 (n=46) | 6.00 mm/hr |
Secondary
Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Participant's fatigue was assessed by answering question 1 of BASDAI on a 0 to 10 VAS; participants were asked: How would you describe the overall level of fatigue/tiredness you have experienced? 0=none and 10=very severe.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline (n=45) | 1.70 units on a scale |
| Etanercept | Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 1 (n=33) | 2.00 units on a scale |
| Etanercept | Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 2 (n=27) | 1.50 units on a scale |
| Etanercept | Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 3 (n=48) | 2.00 units on a scale |
Secondary
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs).
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for each parameter at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Baseline: Total Cholesterol (n=42) | 189.50 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Baseline: High Density Lipoprotein (n=18) | 53.00 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Baseline: Triglycerides (n=34) | 77.00 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 1: Total Cholesterol (n=35) | 191.00 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 1: High Density Lipoprotein (n=24) | 58.00 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 1: Triglycerides (n=32) | 89.50 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 2: Total Cholesterol (n=39) | 191.00 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 2: High Density Lipoprotein (n=28) | 57.00 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 2: Triglycerides (n=34) | 103.50 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 3: Total Cholesterol (n=40) | 184.00 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 3: High Density Lipoprotein (n=23) | 51.00 milligram per deciliter (mg/dL) |
| Etanercept | Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Year 3: Triglycerides (n=32) | 102.50 milligram per deciliter (mg/dL) |
Secondary
Modified Schober's Test
Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured (in cm rounded to the nearest 0.1 cm) with participant maximally bend forward, knees fully extended, with spine in full flexion. The measurement of two attempts was made.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Modified Schober's Test | Baseline (n=43) | 17.75 cm |
| Etanercept | Modified Schober's Test | Year 1 (n=25) | 13.00 cm |
| Etanercept | Modified Schober's Test | Year 2 (n=25) | 11.00 cm |
| Etanercept | Modified Schober's Test | Year 3 (n=44) | 15.45 cm |
Secondary
Number of Participants Who Received Non-pharmacological Treatment
Participants who received any non-pharmacological treatment (participant education, regular exercises and physical therapy) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.
Time frame: Baseline up to Year 3
Population: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Number of Participants Who Received Non-pharmacological Treatment | 3 participants |
Secondary
Number of Participants Who Received Pharmacological Treatment
Participants who received any pharmacological treatment (non-steroidal anti-inflammatory drugs \[NSAIDs\], disease-modifying antirheumatic drugs \[DMARDs\], corticosteroids and other treatments including anti-tumor necrosis factor-alpha \[TNFalpha\] or other biological agents etc.) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.
Time frame: Baseline up to Year 3
Population: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants Who Received Pharmacological Treatment | NSAIDs | 55 participants |
| Etanercept | Number of Participants Who Received Pharmacological Treatment | DMARDs | 15 participants |
| Etanercept | Number of Participants Who Received Pharmacological Treatment | Corticosteroids | 7 participants |
| Etanercept | Number of Participants Who Received Pharmacological Treatment | Other | 26 participants |
Secondary
Occiput-to-wall Distance
Occiput-to-wall distance: 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. The distance between the occiput and the wall was measured in cm (rounded to the nearest 0.1 cm), in two attempts.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Occiput-to-wall Distance | Baseline (n=43) | 0.00 cm |
| Etanercept | Occiput-to-wall Distance | Year 1 (n=25) | 0.00 cm |
| Etanercept | Occiput-to-wall Distance | Year 2 (n=22) | 2.00 cm |
| Etanercept | Occiput-to-wall Distance | Year 3 (n=45) | 0.00 cm |
Secondary
Patient Global Assessment (PtGA) of Disease Activity Score
Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Patient Global Assessment (PtGA) of Disease Activity Score | Baseline (n=43) | 1.70 mm |
| Etanercept | Patient Global Assessment (PtGA) of Disease Activity Score | Year 1 (n=33) | 2.00 mm |
| Etanercept | Patient Global Assessment (PtGA) of Disease Activity Score | Year 2 (n=32) | 2.00 mm |
| Etanercept | Patient Global Assessment (PtGA) of Disease Activity Score | Year 3 (n=49) | 1.40 mm |
Secondary
Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Participant's spinal pain - was assessed by answering question 2 of BASDAI on a 0 to10 VAS; participants were asked: How would you describe the overall level of ankylosing spondylitis neck, back or hip pain you have had? 0 =none and 10 =very severe.
Time frame: Baseline, Year 1, 2, 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept | Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline (n=45) | 2.20 units on a scale |
| Etanercept | Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 1 (n=33) | 2.90 units on a scale |
| Etanercept | Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 2 (n=27) | 3.00 units on a scale |
| Etanercept | Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Year 3 (n=48) | 2.00 units on a scale |
Secondary
Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist
Time passed since the ankylosing spondylitis symptoms started until the participant arrived for the first time to visit the rheumatologist was reported. Ankylosing spondylitis symptoms may include pain, stiffness, axial manifestations, and enthesitis etc.
Time frame: Baseline
Population: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist | 6.35 years | Standard Deviation 7.27 |
Secondary
Time to Diagnosis of Ankylosing Spondylitis
Time to first diagnosis of alkylosing spondylitis was reported.
Time frame: Baseline
Population: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Time to Diagnosis of Ankylosing Spondylitis | 7.53 years | Standard Deviation 8.01 |
Secondary
Time to Treatment Discontinuation With Etanercept
Time to treatment discontinuation with etanercept was assessed retrospectively at Year 3 for participants who did not discontinue treatment at the end of previous LoadET study 0881A3-102090 (NCT00873730). It was defined as time from first dose of etanercept received in the previous LoadET study 0881A3-102090 (NCT00873730) to last dose of etanercept.
Time frame: Year 3
Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Time to Treatment Discontinuation With Etanercept | 3.56 years |