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The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

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ClinicalTrials.gov Identifier: NCT02570750
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Chronic Plaque Psoriasis
Intervention Behavioral: QUESTIONNAIRE ON SMOKING HABITS
Enrollment 183
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per summary of product characteristics (SmPC), were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Period Title: Overall Study
Started 110 73
Completed 96 68
Not Completed 14 5
Reason Not Completed
Inclusion/exclusion criteria deviation             1             0
Protocol deviation             4             2
Withdrawal by Subject             5             0
Lost to Follow-up             2             2
Adverse Event             2             1
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers Total
Hide Arm/Group Description Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. Total of all reporting groups
Overall Number of Baseline Participants 96 68 164
Hide Baseline Analysis Population Description
Per protocol set included all treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 68 participants 164 participants
52.3  (13.5) 49.1  (14.5) 51.0  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 68 participants 164 participants
Female
38
  39.6%
31
  45.6%
69
  42.1%
Male
58
  60.4%
37
  54.4%
95
  57.9%
1.Primary Outcome
Title Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
Hide Description PASI 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 on a scale of 0 (no involvement) to 6 (90–100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set included all treated participants.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Overall Number of Participants Analyzed 96 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 23.1  (6.2) 23.4  (6.1)
Change at Week 24 16.5  (5.2) 17.1  (5.4)
2.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI)
Hide Description 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): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame Baseline, Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set included all treated participants.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Overall Number of Participants Analyzed 96 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 22.0  (5.3) 21.7  (4.8)
Change at Week 12 12.3  (6.0) 12.8  (4.9)
Change at Week 24 16.4  (6.0) 16.8  (4.6)
3.Secondary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
Hide Description PASI 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 on a scale of 0 (no involvement) to 6 (90–100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline.
Time Frame Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set included all treated participants.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Overall Number of Participants Analyzed 96 68
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 9.3 4.4
Week 24 45.8 44.1
4.Secondary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24
Hide Description PASI 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 on a scale of 0 (no involvement) to 6 (90–100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline.
Time Frame Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set included all treated participants.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Overall Number of Participants Analyzed 96 68
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 77.0 82.3
Week 24 97.9 98.5
5.Secondary Outcome
Title Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
Hide Description PASI 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 on a scale of 0 (no involvement) to 6 (90–100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set included all treated participants.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Overall Number of Participants Analyzed 96 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.6  (4.4) 12.8  (4.6)
6.Secondary Outcome
Title Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants
Hide Description PASI 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 on a scale of 0 (no involvement) to 6 (90–100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index >30 kilogram per meter square were said to be obese in this outcome measure.
Time Frame Baseline, Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set included all treated participants. Here, "N" (overall number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
Overall Number of Participants Analyzed 36 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 24.2  (6.12) 23.9  (7.14)
Change at Week 12 12.2  (4.52) 12.1  (5.21)
Change at Week 24 17.1  (5.79) 16.8  (4.26)
Time Frame Baseline up to 1 year
Adverse Event Reporting Description Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
 
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician’s discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
All-Cause Mortality
Etanercept: Non Smokers Etanercept: Smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)   1/68 (1.47%) 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept: Non Smokers Etanercept: Smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   2/96 (2.08%)   3/68 (4.41%) 
Endocrine disorders     
Diabetic gangrene * 1  1/96 (1.04%)  0/68 (0.00%) 
Immune system disorders     
Erytrodermic psoriasis * 1  0/96 (0.00%)  1/68 (1.47%) 
Infections and infestations     
Inflammation at site injection * 1  0/96 (0.00%)  1/68 (1.47%) 
Nervous system disorders     
Cerebellar haematoma * 1  1/96 (1.04%)  0/68 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/96 (0.00%)  1/68 (1.47%) 
1
Term from vocabulary, MedDRA v20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept: Non Smokers Etanercept: Smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   4/96 (4.17%)   4/68 (5.88%) 
Blood and lymphatic system disorders     
Leukopenia * 1  1/96 (1.04%)  0/68 (0.00%) 
General disorders     
Injection site erythema * 1  0/96 (0.00%)  1/68 (1.47%) 
Infections and infestations     
Urinary tract infection * 1  1/96 (1.04%)  1/68 (1.47%) 
Investigations     
Increase of serum transaminases * 1  0/96 (0.00%)  1/68 (1.47%) 
Renal and urinary disorders     
Proteinuria * 1  1/96 (1.04%)  0/68 (0.00%) 
Skin and subcutaneous tissue disorders     
Erytrodermic psoriasis * 1  1/96 (1.04%)  0/68 (0.00%) 
Pustular psoriasis * 1  0/96 (0.00%)  1/68 (1.47%) 
1
Term from vocabulary, MedDRA v20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02570750     History of Changes
Other Study ID Numbers: B1801392
First Submitted: October 5, 2015
First Posted: October 7, 2015
Results First Submitted: June 4, 2018
Results First Posted: December 20, 2018
Last Update Posted: December 20, 2018