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Patients With Psoriasis Experience Improved Quality of Life Following Adalimumab Treatment: Presented at EADV

By Jenny Powers

BERLIN -- October 13, 2009 -- Patients reported improved quality of life with adalimumab (ADA) both as a monotherapy and in combination with topical calcipotriol/betamethasone (ADA + C/B), according to study results presented here on October 8 at the 18th Congress of the European Academy of Dermatology and Venereology (EADV).

Andreas Katsambas, MD, PhD, General Hospital, Athens, Greece, reported on the BELIEVE study (Adalimumab in Combination With Topical Treatment [Calcipotriol/Betamethasone] in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment). The study sought to determine the effect of ADA + C/B compared with ADA + vehicle on patient-reported outcome (PRO) measurements.

The BELIEVE study was a phase 3b, 16-week randomised controlled trial that enrolled 730 patients with moderate to severe psoriasis. In all, patients were administered ADA (80 mg at week 0 and 40 mg every other week at weeks 1 to 15) and either a topical placebo vehicle or topical C/B (once daily for 4 weeks, then as needed).

The primary study endpoint was the percentage of patients who achieved PASI 75 at week 16.

Of the patients, 366 received ADA plus C/B, and 364 were given ADA plus vehicle; patients had received prior treatments of cyclosporine (n = 55%); methotrexate (n = 70%); photochemotherapy (n = 43%); and biologics (n = 48%). They had a mean PASI of 19.5 and affected body surface area of 33%.

At week 16, 64.8% of patients receiving ADA + C/B achieved a PASI 75 response rate compared with 70.9% in the group receiving ADA + vehicle (P = .086). There was a mean improvement in the Dermatology Life Quality Index (DLQI) of -67.2% compared with -71.5% (P = .228).

At week 2, efficacy was greater with combination therapy than with ADA monotherapy (week 2 DLQI in the ADA + C/B group was -47.5% vs -32.1% in the ADA + vehicle group, [P < .001]).

Pain and pruritus, as reported by patients, improved similarly for both groups.

The researchers concluded that, based upon these study results, clinically relevant improvements were demonstrated by all PRO assessments, indicating improved patient quality of life. The most rapid results were seen in the ADA + C/B treatment group; however improvement in the degree of psoriasis severity was seen in both adalimumab treatment groups.

Funding for this study was provided by Abbott Laboratories.

[Presentation title: Improvement in Quality of Life in Patients Treated With Adalimumab Plus Adjunctive Topical Therapy (Calcipotriol/Betamethasone) for Moderate to Severe Psoriasis: Results of the BELIEVE Study. Abstract P1169]

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