Advances in Psoriasis by Jeffrey M. Weinberg & Mark Lebwohl

Author:Jeffrey M. Weinberg & Mark Lebwohl
Language: eng
Format: epub
Publisher: Springer London, London

ADEPT

Adalimumab has also been studied in psoriatic arthritis. ADEPT was a phase III randomized, double-blind, parallel-group, placebo controlled trial examining adalimumab efficacy and safety in psoriatic arthritis patients [36]. Like other psoriatic arthritis trials, patients who had moderately to severely active psoriatic arthritis and a history of inadequate response to non-steroidal anti-inflammatory drugs (NSAIDS) were eligible to participate. Patients were stratified by methotrexate use and psoriasis skin involvement (≥3 % BSA or <3 %). Approximately half of patients were taking methotrexate at baseline. Patients in the adalimumab arm received 40 mg adalimumab subcutaneously every other week for 48 weeks. If improvement was not seen at week 12 (defined as at least a 20 % decrease in both swollen and tender joint counts on two consecutive visits), participants could receive corticosteroids or disease modifying anti-rheumatic drugs (DMARDS). Primary endpoints were the American College of Rheumatology 20 % improvement (ACR20) response at week 12 and changes in modified total Sharp score (mTSS) of structural damage at week 24. In addition, HRQoL was measured in all patients. For those patients who also had 3 % or more body surface area of psoriasis, skin improvement was also measured.

At 12 weeks, 58 % of the adalimumab group achieved ACR20, compared to 14 % of the placebo group (Table 13.8). Patients in the adalimumab group had a modified Psoriatic Arthritis Response Criteria (PsARC) response rate of 62 % at week 12, and 60 % at week 24, compared to placebo rates of 26 % at week 12 and 23 % at week 24. Adalimumab also inhibited joint destruction, as is seen with the TNF-inhibitors etanercept and infliximab [37]. Radiographs were taken at baseline and at week 24. The mean change in mTSS was −0.2 for patient receiving adalimumab compared to 1.0 for those receiving placebo. Erosion scores were examined, and there was improvement in those receiving adalimumab (mean change 0) compared to placebo (mean change 0.6). When joint space narrowing scores were examined, there was a mean change of −2 in the adalimumab group compared to 0.4 in those receiving placebo. Skin symptoms also improved in those patients who also had psoriasis (see Table 13.8). Improvements in health related quality of life, fatigue, and disability, measured using the DLQI, SF-36, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale and HAQ DI were also seen [38]. HAQ DI scores improved significantly in patients receiving adalimumab compared to the control group.Table 13.8Adalimumab efficacy in ADEPT at weeks 12 and 24

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