Apremilast Leads to Early, Sustained Improvements in Biologic-Naïve Active Psoriatic Arthritis
In biologic-naïve psoriatic arthritis (PsA) patients treated with apremilast (APR), early onset of effect was observed across PsA manifestations, including morning stiffness severity and enthesitis, with improvements sustained through week 104 in those continuing APR therapy, according to the results of the phase 3b, randomized, placebo-controlled ACTIVE trial presented at the 2018 European League Against Rheumatism (EULAR) Congress held in Amsterdam from June 13 to June 16.
The ACTIVE trial randomly assigned 219 patients to APR (n=110) or placebo (n=109). Overall, 89% (142/160) of the study participants who entered year 2 of the study completed the week 104 visit, and 64.8% (142/219) of randomized participants completed the week 104 visit, including 60.9% (67/110) of those randomized to APR at baseline.
Early onset of response to APR was observed for the American College of Radiology 20 (ACR20) response, which requires at least 20% improvement in the core set measures for a patient to be considered responsive. There were also improvements in Disease Activity Score in 28 joints (DAS28-CRP), Health Assessment Questionnaire Disability Index (HAQ-DI), enthesitis (in those with the condition at baseline), and morning stiffness severity.
Following continued APR exposure, at week 104, the ACR20 response rate was 62.9%, the ACR50 response rate was 33.3%, and the ACR70 response rate was 20.1%. The mean percentage change in swollen joint count was −75.9%, and the mean percentage change in tender joint count was −68.3%. Overall, 65.7% of APR-treated patients with baseline enthesitis reached a Gladman Enthesitis Index score of 0. Additionally, more than 50% of APR-treated patients had improvements in morning stiffness severity, and there were sustained improvements in physical function, with a mean change of 5.9 in the Short-Form Health Survey version 2 (SF-36v2) physical functioning score and a mean change in HAQ-DI score of −0.37 at week 104.
No new safety issues were observed. The most commonly reported adverse effects (AEs; ≥5% of subjects) during the APR-exposure period included diarrhea (16.5%), nausea (8.7%), upper respiratory tract infection (8.3%), nasopharyngitis (8.3%), hypertension (6.3%), headache (6.3%), and bronchitis (5.3%). New incidences of protocol-defined diarrhea (≥2 watery/liquid stools/day) decreased during long-term APR exposure. Over the APR-exposure period, serious AEs occurred in 7.3% of participants, and 8.3% of participants discontinued treatment due to an AE.
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Nahs P, Ohson K, Walsh J, et al. Sustained improvements with up to 104 weeks of apremilast monotherapy in biologic-naïve subjects with active psoriatic arthritis: results from a phase 3b, randomized, controlled trial. Presented at: European League Against Rheumatism (EULAR) Congress 2018; June 13-16, 2018; Amsterdam, The Netherlands. Abstract AB0943.