|The following article is part of conference coverage from the European League Against Rheumatism (EULAR) Congress 2018 in Amsterdam, The Netherlands. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from EULAR 2018.|
In biologic-naive patients with psoriatic arthritis (PsA) who are treated with apremilast, early onset of effect was observed across PsA manifestations, including morning stiffness severity and enthesitis, with sustained improvements reported through 104 weeks in participants who continued apremilast therapy, according to the results of the phase 3b, randomized, controlled ACTIVE trial presented at the European League Against Rheumatism (EULAR) Congress held in Amsterdam, June 13 to 16, 2018.
The ACTIVE study is the first of its kind to demonstrate the onset of response to apremilast beginning at 2 weeks in biologic-naive patients with PsA who may have had prior exposure to a conventional disease-modifying antirheumatic drug. The investigators sought to determine the efficacy and safety of apremilast through 104 weeks in the ACTIVE study. Participants were randomly assigned in a 1:1 ratio to receive apremilast 30 mg twice daily or placebo for 24 weeks. After 24 weeks, all participants received active treatment with apremilast.
A total of 219 patients were randomly assigned to receive apremilast (n=110) or placebo (n=109). Overall, 89% (142 of 160) of the participants who entered the second year of the study completed the visit at 104 weeks. Moreover, 64.8% (142 of 219) of participants completed the visit at 104 weeks, which included 60.9% (67 of 110) of the participants who were randomly assigned to receive apremilast at baseline.
Early onset of response to apremilast was observed for American College of Rheumatology 20% improvement (ACR20) response, along with improvements in Disease Activity Score in 28 joints (DAS28-CRP), Health Assessment Questionnaire Disability Index (HAQ-DI), enthesitis, and severity of morning stiffness.
With continued apremilast therapy, ACR20 response rate at 104 weeks was 62.9%, and ACR50 and ACR70 response rates were 33.3% and 20.1%, respectively. The mean percentage change in swollen joint count was −75.9%, and mean percentage change in tender joint count was −68.3%. Overall, 65.7% of apremilast-treated patients with baseline enthesitis achieved a Gladman Enthesitis Index score of 0. Improvements in severity of morning stiffness was achieved by more than half of the apremilast-treated participants. Researchers also observed 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 HAAQ-DI score of −0.37 at 104 weeks.
The most frequently reported adverse events (≥5% of participants) during the apremilast exposure period included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, hypertension, headache, and bronchitis. During long-term apremilast treatment, serious adverse events were reported in 7.3% of participants, and 8.3% discontinued treatment because of an adverse event.
The investigators concluded that long-term treatment with apremilast was associated with sustained improvements across PsA manifestations, with adverse events consistent with those reported for other phase 3 apremilast studies in psoriasis and PsA.
Disclosures: P. Nash Grant received research support from Celgene Corporation; K. Ohson Grant received research support from Celgene Corporation; J. Walsh Grant received research support from Amgen, Pfizer, UCB, Celgene Corporation, Novartis; N. Delev is an employee of Celgene Corporation; D. Nguyen is an employee of Celgene Corporation; L. Teng is an employee of Celgene Corporation; M. Paris is an employee of Celgene Corporation; J. Gomez-Reino Grant received research support from Roche and Schering-Plough and is a consultant for BMS, Pfizer, Roche, Schering-Plough, UCB; J. Aelion Grant received research support from AbbVie, Ardea Biosciences, AstraZeneca, BMS, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, Takeda Pharmaceuticals, UCB, Vertex Pharmaceuticals.
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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.