Plaque Psoriasis
Conditions
Keywords
plaque psoriasis, smoking, etanercept
Brief summary
Pilot observational study to describe the relationship between the smoking status of a psoriatic individual and the success of etanercept therapy in psoriasis treatment
Detailed description
non-interventional study There is no sampling
Interventions
BEHAVIORALsmoking questionnaire
patients fill in a smoking questionnaire about their smoking habits
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator Patients who are scheduled by their dermatologist to initiate treatment with Etanercept
Exclusion criteria
Previous or current treatment with antipsoriatic biologic drugs, such as etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab Chronic or acute infections requiring intravenous or oral anti-infectives within 14 days prior to the Baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Baseline (Day 1), Week 24 | PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 | Baseline, Week 12 | PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. |
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 12, 24 | PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. |
| Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24 | Baseline, Week 12, 24 | Percentage improvement in PASI score from baseline was calculated at Week 12 and 24 in terms of percent change from baseline. PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted | Day 1 | Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking which included the age of participants at which they started smoking and the age at which they quitted smoking. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. |
| Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants | Day 1 | Smoking habit questionnaire which was conducted on Day 1, assessed the data on smoking which included the mean duration (in years) of smoking among participants. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. |
| Smoking Habit Questionnaire: Smoking Status of Participants | Day 1 | Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking status of participants. Smoking status of participants was classified as never smoked, current smokers, and former smokers. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. |
Countries
Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician's discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet the exclusion criteria | 1 |
| Overall Study | Other | 8 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 47.37 years STANDARD_DEVIATION 15.59 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Time frame: Baseline (Day 1), Week 24
Population: All treated participants with available post-baseline documentation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Baseline | 21.02093 units on a scale | Standard Deviation 6.298742 |
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Change at Week 24 | -18.40349 units on a scale | Standard Deviation 6.606279 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Baseline | 20.40769 units on a scale | Standard Deviation 4.991266 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Change at Week 24 | -15.64615 units on a scale | Standard Deviation 8.649496 |
95% CI: [-5.916307, 0.401638]
Secondary
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Time frame: Baseline, Week 12
Population: All treated participants with available post-baseline documentation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 | -18.18837 units on a scale | Standard Deviation 6.236787 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 | -17.27692 units on a scale | Standard Deviation 6.819402 |
95% CI: [-3.73847, 1.915572]
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
Time frame: Week 12, 24
Population: All treated participants with available post-baseline documentation.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept: Non Smokers | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 24 | 86.05 percentage of participants | — |
| Etanercept: Non Smokers | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 12 | 82.56 percentage of participants | 6.937556 |
| Etanercept: Smokers | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 24 | 69.23 percentage of participants | — |
| Etanercept: Smokers | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 12 | 76.92 percentage of participants | 8.768914 |
Secondary
Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24
Percentage improvement in PASI score from baseline was calculated at Week 12 and 24 in terms of percent change from baseline. PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Time frame: Baseline, Week 12, 24
Population: All treated participants with available post-baseline documentation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Non Smokers | Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24 | Week 12 | 0.139 percent change | Standard Deviation 0.163 |
| Etanercept: Non Smokers | Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24 | Week 24 | 0.120 percent change | Standard Deviation 0.196 |
| Etanercept: Smokers | Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24 | Week 12 | 0.168 percent change | Standard Deviation 0.218 |
| Etanercept: Smokers | Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24 | Week 24 | 0.257 percent change | Standard Deviation 0.358 |
Other Pre-specified
Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted
Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking which included the age of participants at which they started smoking and the age at which they quitted smoking. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.
Time frame: Day 1
Population: All treated participants with available post-baseline documentation. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for each arm. Data for this outcome measure was planned to be analyzed in smokers and former smokers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Non Smokers | Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted | Age when participants started smoking (n =61) | 18.55738 years | Standard Error 0.7493256 |
| Etanercept: Non Smokers | Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted | Age when participants quitted smoking (n =35) | 21.25714 years | Standard Error 2.165948 |
Other Pre-specified
Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants
Smoking habit questionnaire which was conducted on Day 1, assessed the data on smoking which included the mean duration (in years) of smoking among participants. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.
Time frame: Day 1
Population: All treated participants with available post-baseline documentation. Here, 'N' signifies those participants who were evaluable for this measure. Data for this outcome measure was planned to be analyzed in smokers and former smokers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Non Smokers | Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants | 21 years | Standard Error 1.604808 |
Other Pre-specified
Smoking Habit Questionnaire: Smoking Status of Participants
Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking status of participants. Smoking status of participants was classified as never smoked, current smokers, and former smokers. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.
Time frame: Day 1
Population: All treated participants with available post-baseline documentation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Non Smokers | Smoking Habit Questionnaire: Smoking Status of Participants | Never smoke | 51 participants |
| Etanercept: Non Smokers | Smoking Habit Questionnaire: Smoking Status of Participants | Current smokers | 0 participants |
| Etanercept: Non Smokers | Smoking Habit Questionnaire: Smoking Status of Participants | Former smokers | 35 participants |
| Etanercept: Smokers | Smoking Habit Questionnaire: Smoking Status of Participants | Never smoke | 0 participants |
| Etanercept: Smokers | Smoking Habit Questionnaire: Smoking Status of Participants | Current smokers | 26 participants |
| Etanercept: Smokers | Smoking Habit Questionnaire: Smoking Status of Participants | Former smokers | 0 participants |