Articular and extra-articular benefits in ACR20 non-responders at week 104 treated with apremilast: pooled analysis of three randomized controlled trials

Mease, P. J., Gladman, D. D., Kavanaugh, A., McGonagle, D., Nash, P., Guerette, B., Nakasato, P., Brunori, M., Teng, L. and McInnes, I. B. (2021) Articular and extra-articular benefits in ACR20 non-responders at week 104 treated with apremilast: pooled analysis of three randomized controlled trials. Rheumatology and Therapy, 8(4), pp. 1677-1691. (doi: 10.1007/s40744-021-00369-x) (PMID:34536218)

Abstract

Introduction: PALACE 1, 2, and 3 were phase 3 studies aimed to evaluate apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior treatment with conventional disease-modifying anti-rheumatic drugs and/or biologics. The pooled analysis reported here further characterized the clinical outcomes associated with long-term apremilast exposure in patients failing to achieve ≥ 20% improvement in the American College of Rheumatology response criteria (ACR20) at Week 104. Methods: Patients randomized to apremilast 30 mg twice daily at baseline and classified as ACR20 non-responders (ACR20NRs) or ACR20 responders (ACR20Rs) at Week 104 were included. Efficacy outcomes included change from baseline to Week 104 in ACR core components and other endpoints. Results: At Week 104, a total of 109 patients were ACR20NRs and 193 were ACR20Rs. As expected, the ACR20R group had improvements in all indices assessed. The ACR20NR group demonstrated substantial mean improvements from baseline in swollen joint count (SJC; − 58%), tender joint count (TJC; − 42%), and Physician’s Global Assessment of Disease Activity (PhGA; − 44%); resolution of enthesitis (34%) and dactylitis (68%); and achievement of ≥ 75% reduction from baseline Psoriasis Area and Severity Index scores (among patients with psoriasis involving ≥ 3% of the body surface area) (36%). Conclusion: Despite not fulfilling a formal ACR20 response at Week 104, ACR20NRs experienced sustained improvements in several PsA core domains, including SJC, TJC, enthesitis, dactylitis, and psoriasis, as well as the PhGA (visual analog scale) scores, with apremilast treatment. Trial Registration: ClinicalTrials.gov identifier: NCT01172938, NCT01212757, and NCT01212770.

• Item Type: Articles
• Additional Information: This study was funded by Celgene. Amgen Inc. acquired the worldwide rights to Otezla® (apremilast) on 21 November 2019. Amgen Inc. also funded the Rapid Service Fee of Rheumatology and Therapy.
• Keywords: Psoriatic arthritis, articular, extra-articular, apremilast, ACR20 non-responders.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McInnes, Professor Iain
• Authors: Mease, P. J., Gladman, D. D., Kavanaugh, A., McGonagle, D., Nash, P., Guerette, B., Nakasato, P., Brunori, M., Teng, L., and McInnes, I. B.
• College/School: College of Medical Veterinary and Life Sciences > School of Infection & Immunity
• Research Centre: College of Medical Veterinary and Life Sciences > School of Infection & Immunity > Centre for Immunobiology
• Journal Name: Rheumatology and Therapy
• Publisher: Springer
• ISSN: 2198-6576
• ISSN (Online): 2198-6584
• Published Online: 18 September 2021
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in Rheumatology and Therapy 8(4): 1677-1691
• Publisher Policy: Reproduced under a Creative Commons License