Psoriatic Inflammation Markers Predictive of Response to Adalimumab (IMPRA)

Poitiers University Hospital

Status

Completed

Conditions

Psoriasis Vulgaris

Treatments

Diagnostic Test: cutaneous

Study type

Interventional

Funder types

Other

Identifiers

NCT03389984

IMPRA

Details and patient eligibility

About

The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and Severity Index 75 response at 16 weeks) with the transcriptomic profile of patient non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order to define predictive markers of response to the treatment.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic plaque psoriasis involving at least 10% of body surface area, with a PASI score >10,
Negative pregnancy test for women of childbearing potential, and use of an effective method of contraception,
Pretreatment assessment to identify contraindications to anti-tumor necrosis factor-alpha therapy (chest x-ray and Intradermal reaction (detection of latent tuberculosis),
Anti-tumor necrosis factor-alpha treatment with adalimumab has been prescribed

Exclusion criteria

Classical exclusion criteria for adalimumab therapy (hypersensitivity to the product, severe heart failure, abscess, tuberculosis or other opportunistic infection),
History of demyelinating disease, any unstable medical condition, patients with recurrent serious infections , history of cardiovascular or cerebrovascular disease , history of cancer
Patients not having tuberculosis prophylaxis as per local guidelines for latent tuberculosis, or patients non-treated active tuberculosis
Ongoing pregnancy or breastfeeding
Absence of written consent,
Prior treatment with one of the following anti-psoriatic treatments: biologics during the 3 months prior baseline visit, other systemic treatment during the 4 weeks prior baseline visit or topical therapy during the 2 weeks prior baseline visit.