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

Launched by PFIZER · Oct 5, 2015

Keywords

ClinConnect Summary

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 t...

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Eligibility criteria

• 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