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

Pfizer

Status: Completed

Conditions: Chronic Plaque Psoriasis

Treatments: Behavioral: QUESTIONNAIRE ON SMOKING HABITS

Study type: Observational

Funder types: Industry

Identifiers

NCT02570750

B1801392

Details and patient eligibility

About

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.

Full 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

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

183 participants in 2 patient groups

Group 1: smokers patients group

Description:

smokers (more than 10 cigarettes per day)

Treatment:

Behavioral: QUESTIONNAIRE ON SMOKING HABITS

Group 2 : non-smokers patients group

Description:

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

Treatment:

Behavioral: QUESTIONNAIRE ON SMOKING HABITS