Trial Outcomes & Findings for Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis (NCT NCT02192164)
NCT ID: NCT02192164
Last Updated: 2017-06-28
Results Overview
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.
COMPLETED
126 participants
Baseline (Day 1), Week 24
2017-06-28
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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126
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Overall Study
Etanercept Treated Population
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112
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Overall Study
COMPLETED
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112
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Overall Study
NOT COMPLETED
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14
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Other
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8
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Physician Decision
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4
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Overall Study
Did not meet the exclusion criteria
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1
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Baseline Characteristics
Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis
Baseline characteristics by cohort
| Measure |
Etanercept
n=112 Participants
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.
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Age, Continuous
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47.37 years
STANDARD_DEVIATION 15.59 • n=5 Participants
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Sex: Female, Male
Female
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45 Participants
n=5 Participants
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Sex: Female, Male
Male
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67 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 1), Week 24Population: All treated participants with available post-baseline documentation.
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.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=86 Participants
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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Etanercept: Smokers
n=26 Participants
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
Baseline
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21.02093 units on a scale
Standard Deviation 6.298742
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20.40769 units on a scale
Standard Deviation 4.991266
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Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
Change at Week 24
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-18.40349 units on a scale
Standard Deviation 6.606279
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-15.64615 units on a scale
Standard Deviation 8.649496
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SECONDARY outcome
Timeframe: Baseline, Week 12Population: All treated participants with available post-baseline documentation.
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.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=86 Participants
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
|
Etanercept: Smokers
n=26 Participants
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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|---|---|---|
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Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
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-18.18837 units on a scale
Standard Deviation 6.236787
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-17.27692 units on a scale
Standard Deviation 6.819402
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SECONDARY outcome
Timeframe: Week 12, 24Population: All treated participants with available post-baseline documentation.
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.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=86 Participants
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
|
Etanercept: Smokers
n=26 Participants
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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|---|---|---|
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Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
Week 12
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82.56 percentage of participants
6.937556
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76.92 percentage of participants
8.768914
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Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
Week 24
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86.05 percentage of participants
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69.23 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: All treated participants with available post-baseline documentation.
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.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=86 Participants
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
|
Etanercept: Smokers
n=26 Participants
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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|---|---|---|
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Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24
Week 12
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0.139 percent change
Standard Deviation 0.163
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0.168 percent change
Standard Deviation 0.218
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Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24
Week 24
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0.120 percent change
Standard Deviation 0.196
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0.257 percent change
Standard Deviation 0.358
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OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: All treated participants with available post-baseline documentation.
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.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=86 Participants
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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Etanercept: Smokers
n=26 Participants
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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|---|---|---|
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Smoking Habit Questionnaire: Smoking Status of Participants
Never smoke
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51 participants
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0 participants
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Smoking Habit Questionnaire: Smoking Status of Participants
Current smokers
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0 participants
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26 participants
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Smoking Habit Questionnaire: Smoking Status of Participants
Former smokers
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35 participants
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0 participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=61 Participants
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
|
Etanercept: Smokers
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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|---|---|---|
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Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted
Age when participants started smoking (n =61)
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18.55738 years
Standard Error 0.7493256
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—
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Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted
Age when participants quitted smoking (n =35)
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21.25714 years
Standard Error 2.165948
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=61 Participants
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
|
Etanercept: Smokers
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
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|---|---|---|
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Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants
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21 years
Standard Error 1.604808
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—
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Adverse Events
Etanercept: Non Smokers
Etanercept: Smokers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER