Adalimumab Superior to Placebo for Patient-Reported Outcomes in PsA

An analysis of the randomized, controlled ADEPT trial was presented at the ACR/ARP Annual Meeting and demonstrated adalimumab’s superiority to placebo among patients with psoriatic arthritis (PsA).

The study compared the effects of adalimumab versus placebo on patient-reported outcomes (PROs) in patients with PsA after 12 weeks of treatment. A total of 315 patients with moderate-to-severe disease and no history of receiving biologic disease-modifying antirheumatic drugs were randomized to receive adalimumab 40 mg (n=151) or placebo (n=162) every other week.

The following PROs were evaluated at baseline and 12 weeks: the 36-item Short-Form (SF-36) Health Survey physical (PCS) and mental component summary (MCS) scores, eight domain scores on a 100-point scale (0=worst), and the SF-6D utility measure derived from all eight SF-36 domains (scores ranged from 0.296 [worst] to 1.00 [best]; minimally important difference [MID] was 0.041). Patients were also evaluated using the Patient Global Assessment of disease activity (PtGA) and pain, both of which used a 100 mm visual analog scale, and Health Assessment Questionnaire disability index (HAQ-DI). Outcomes included mean changes from baseline, proportion of patients with improvements meeting or exceeding minimum clinically important differences (MCID), and scores meeting or exceeding age- and sex-matched normative values.

Baseline PROs did not largely differ between the groups, but by week 12, the adalimumab group presented significantly greater improvements compared with the placebo group in PtGA, pain, HAQ-DI, and SF-36 PCS (change, 9.3 vs. 1.4; P<0.001) but not in SF-36 MCS (1.6 vs. 1.2). The adalimumab group also presented significantly greater improvements in six of the eight SF-36 domains: physical functioning, role physical, bodily pain, general health, social functioning, and vitality. Improvements in SF-6D exceeded MID with adalimumab (change, 0.071) but not placebo (0.018).

Adalimumab-treated patients had SF-6D scores (0.724) that were close to the age- and sex-matched norm (0.778). The adalimumab group had a greater proportion of patients whose improvements met or exceeded the MCID at 12 weeks compared with placebo in all measured outcomes except SF-36 role emotional and mental health domains.