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

Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Behavioral: QUESTIONNAIRE ON SMOKING HABITS

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

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• Romania
  • Arad, Romania, 310112
    • Stoica Dan Marius Dermatology Office Arad
  • Bacau, Romania, 600114
    • Emergency Hospital Bacau / Dermatology Department
  • Botosani, Romania, 710211
    • County Emergency Hospital "Mavromati" Botosani / Dermatology Department
  • Brasov, Romania, 500326
    • County Emergency Hospital Brasov / Dermatology Department
  • Bucharest, Romania, 010825
    • Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department
  • Bucharest, Romania, 011461
    • Elias Emergency University Hospital Bucharest / Dermatology Department
  • Bucharest, Romania, 011464
    • Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department
  • Bucharest, Romania, 020125
    • Clinical Hospital Colentina Bucharest / Dermatology Department
  • Bucharest, Romania, 030303
    • Hospital "Dr. Victor Babes" Bucharest / Dermatology Department
  • Iasi, Romania, 700106
    • County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department
  • Iasi, Romania, 700506
    • Railways Hospital Iasi / Dermatology Department
  • Suceava, Romania, 720019
    • Bucovina Medical Office Suceava
  • Arges
    • Pitesti, Arges, Romania, 110121
      • Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department
    • Pitesti, Arges, Romania, 110283
      • County Emergency Hospital Pitesti / Dermatology Department
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400001
      • SCBI Ambulatory Cluj-Napoca / Dermatology Department
    • Cluj-Napoca, Cluj, Romania, 400105
      • Dr. Remus Orasan Medical Office
  • Dambovita
    • Targoviste, Dambovita, Romania, 130086
      • County Hospital Targoviste / Dermatology Department
  • Dolj
    • Craiova, Dolj, Romania, 200061
      • Dr Ianosi Medical Center Craiova / Dermatology Department
    • Craiova, Dolj, Romania, 200642
      • Emergency County Hospital Craiova / Dermatology Department
    • Craiova, Dolj, Romania, 200642
      • Helios Medica Ambulatory Craiova / Dermatology Department
  • Maramures
    • Baia Mare, Maramures, Romania, 430341
      • Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen
  • Mehedinti
    • Drobeta Turnu Severin, Mehedinti, Romania, 220097
      • County Emergency Hospital Drobeta Turnu Severin / Dermatology Department
  • Mures
    • Reghin, Mures, Romania, 545300
      • Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin
    • Sighisoara, Mures, Romania, 545400
      • Sighisoara Municipal Hospital / Dermatology Department
    • Targu Mures, Mures, Romania, 540342
      • Mures County Clinical Hospital / Dermatology Department
  • Prahova
    • Ploiesti, Prahova, Romania, 100184
      • County Emergency Hospital Ploiesti / Dermatology Department
    • Ploiesti, Prahova, Romania, 100576
      • County Emergency Hospital Ploiesti / Dermatology Department
  • Salaj
    • Zalau, Salaj, Romania, 450123
      • County Emergency Hospital Zalau / Dermatology Department
  • Timis
    • Timisoara, Timis, Romania, 300077
      • Municipal Emergency Hospital Timisoara / Dermatology Department
  • Vrancea
    • Focsani, Vrancea, Romania, 620034
      • County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: smokers patients group; smokers (more than 10 cigarettes per day)	Behavioral: QUESTIONNAIRE ON SMOKING HABITS; Data on smoking will include the age at which cigarette smoking began and ceased and the average amount smoked daily. Intensity (number of cigarettes smoked per day), duration of smoking (years), and time since cessation (years) will be categorized. Also, the smoking status of the patient prior psoriasis diagnosis will be assessed (smoker or non-smoker and years of smoking prior to psoriasis diagnosis). Smoking habit evaluation: baseline and changes in smoking habit at 12 and 24-weeks follow-up time points.
Group 2 : non-smokers patients group; 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	Behavioral: QUESTIONNAIRE ON SMOKING HABITS; Data on smoking will include the age at which cigarette smoking began and ceased and the average amount smoked daily. Intensity (number of cigarettes smoked per day), duration of smoking (years), and time since cessation (years) will be categorized. Also, the smoking status of the patient prior psoriasis diagnosis will be assessed (smoker or non-smoker and years of smoking prior to psoriasis diagnosis). Smoking habit evaluation: baseline and changes in smoking habit at 12 and 24-weeks follow-up time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at 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).	Baseline, Week 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2015
• Primary Completion (Actual): December 5, 2016
• Study Completion (Actual): December 5, 2016

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: B1801392