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

Completed

Conditions: Chronic Plaque Psoriasis

Interventions: Behavioral: QUESTIONNAIRE ON SMOKING HABITS

Registration Number: NCT02570750

Lead Sponsor: Pfizer

Brief Summary: The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis.

Detailed Description: Study hypothesis was based on the following rationale:

* Psoriasis vulgaris is a chronic inflammatory skin disease with several extracutaneous manifestations and significant comorbidities (among others cardiovascular disease, metabolic syndrome, obesity and depression).

* An increased prevalence of smoking among psoriasis patients, as compared with healthy subjects, has been observed in several studies

* More recent studies suggest that cigarette smoking may trigger the development of psoriasis through oxidative, inflammatory and genetic mechanisms.Furthermore, smoking is associated with the clinical severity of psoriasis

* Smoking also contributes to higher morbidity and mortality from smoking related disorders in these patients There is now some evidence that patients with psoriasis who smoke tend to be less responsive to treatment

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 183

Inclusion Criteria

Adult patients aged ≥18 years at the time of screening
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 prescribed independently by the investigator as per local clinical practice guideline
Stable plaque psoriasis for at least 2 months prior to Baseline
Diagnosis of severe psoriasis defined as PASI > 10
Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC)
Smokers with smoking >10 cigarettes daily for smokers group (Group 1) or non-smokers for non-smoking group (Group 2)
Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria

Previous or current treatment with antipsoriatic biologic drugs, such as Etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab.
Exclusion Criteria according to the Enbrel® SmPC, with particular attention to: hypersensitivity to the active substance (etanercept) or to any of the excipients; sepsis or risk of sepsis, active infections, including chronic or localised infections.
Positive pregnancy test, breast feeding or considering becoming pregnant during the study
Clinically significant drug or alcohol abuse

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: smokers patients group	QUESTIONNAIRE ON SMOKING HABITS	smokers (more than 10 cigarettes per day)
Group 2 : non-smokers patients group	QUESTIONNAIRE ON SMOKING HABITS	Smoking status will be classified as current and never/former. Former smokers will be defined as those who had stopped smoking at least 1 year before being interviewed for this study

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24	Baseline, Week 24	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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12	Week 12	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).
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24	Week 12, 24	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.
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants	Baseline, Week 12, 24	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.
Change From Baseline in Dermatology Life Quality Index (DLQI)	Baseline, Week 12, 24	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.
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24	Week 12, 24	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.

Trial Locations

Locations (29): County Emergency Hospital Zalau / Dermatology Department
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Zalau, Salaj, Romania
County Hospital Targoviste / Dermatology Department
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Targoviste, Dambovita, Romania
County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department
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Focsani, Vrancea, Romania
County Emergency Hospital Brasov / Dermatology Department
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Brasov, Romania
Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen
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Baia Mare, Maramures, Romania
Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin
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Reghin, Mures, Romania
Mures County Clinical Hospital / Dermatology Department
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Targu Mures, Mures, Romania
Bucovina Medical Office Suceava
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Suceava, Romania
Dr. Remus Orasan Medical Office
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Cluj-Napoca, Cluj, Romania
Helios Medica Ambulatory Craiova / Dermatology Department
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Craiova, Dolj, Romania
Clinical Hospital Colentina Bucharest / Dermatology Department
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Bucharest, Romania
Railways Hospital Iasi / Dermatology Department
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Iasi, Romania
Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department
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Pitesti, Arges, Romania
SCBI Ambulatory Cluj-Napoca / Dermatology Department
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Cluj-Napoca, Cluj, Romania
Sighisoara Municipal Hospital / Dermatology Department
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Sighisoara, Mures, Romania
Dr Ianosi Medical Center Craiova / Dermatology Department
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Craiova, Dolj, Romania
County Emergency Hospital Pitesti / Dermatology Department
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Pitesti, Arges, Romania
Emergency County Hospital Craiova / Dermatology Department
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Craiova, Dolj, Romania
County Emergency Hospital Drobeta Turnu Severin / Dermatology Department
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Drobeta Turnu Severin, Mehedinti, Romania
Municipal Emergency Hospital Timisoara / Dermatology Department
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Timisoara, Timis, Romania
Emergency Hospital Bacau / Dermatology Department
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Bacau, Romania
County Emergency Hospital Ploiesti / Dermatology Department
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Ploiesti, Prahova, Romania
Stoica Dan Marius Dermatology Office Arad
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Arad, Romania
Elias Emergency University Hospital Bucharest / Dermatology Department
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Bucharest, Romania
County Emergency Hospital "Mavromati" Botosani / Dermatology Department
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Botosani, Romania
Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department
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Bucharest, Romania
Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department
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Bucharest, Romania
Hospital "Dr. Victor Babes" Bucharest / Dermatology Department
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Bucharest, Romania
County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department
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Iasi, Romania