199 Assessment of Disability Levels in a Cohort of 1489 Patients with Active Psoriatic Arthritis and the Effect of Apremilast Treatment: Pooled Data from Three Phase III Randomized Controlled Trials

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Background: PsA reduces physical function. PALACE 1 (NCT01172938), 2 (NCT01212757) and 3 (NCT01212770) compared apremilast (APR) efficacy and safety with placebo in patients with active PsA despite prior conventional DMARDs and/or biologics. The impact of treatment with APR 30 mg twice a day (APR30) on disability over 104 weeks was assessed using the HAQ Disability Index (HAQ-DI) in a pooled analysis of the PALACE 1–3 database.

Methods: Patients were randomized (1:1:1) to placebo, APR30 or APR 20 mg twice a day (APR20). At week 24, the remaining placebo patients were re-randomized to APR30 or APR20. HAQ-DI scores were collected at baseline and weeks 16, 24, 40, 52, 65, 78, 91 and 104. Data were analysed by intention to treat and last observation carried forward (LOCF) for week 16 and described as data observed to week 104. The proportion reaching the minimum clinically important difference (MCID) was calculated. Disability levels were calculated using HAQ-DI cut-off levels ≤1.0 (clinically significant disability), ≤0.5 (minimal disease activity criteria) and ≤0.25. Category shifts showing changes in functionality were observed using 0.25 increments.