Nash P, et al. - Experts sought to assess the effectiveness of apremilast across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naive subjects having PsA. Results suggested that onset of effect with apremilast was observed at week 2 and continued through week 52, in biological-naive patients with PsA. The safety profile was noted to be consistent with previous reports.

Methods

• Authors randomised the patients (1:1) to apremilast 30 mg twice daily or placebo.
• The subjects whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape, at week 16.
• All patients, at week 24, received apremilast through week 52.

Results

• Findings suggested that among 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast vs placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) vs 6.4% (7/109) (P=0.025).
• At week 2, improvements were noted in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, with apremilast.
• It was demonstrated that apremilast markedly reduced PsA disease activity vs placebo at week 16, with changes in DAS-28 (CRP) (P <0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001).
• Through week 52, improvements were maintained with continued treatment.
• Over 52 weeks, consistent safety profile of apremilast’s was noted with prior phase 3 studies in psoriasis and PsA.
• Data revealed that during weeks 0–24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo).
• As per the outcomes, serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo).