Journal article
Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial
- Abstract:
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Objectives: Oligoarticular psoriatic arthritis (PsA) is frequent but rarely studied. The objective was to assess the efficacy of apremilast in early oligoarticular PsA.
Methods: FOREMOST (NCT03747939) was a Phase 4 multicentre, randomised, double-blind, placebo-controlled trial. Patients had early (symptom duration ≤5 years) oligoarticular PsA (>1 but ≤4 swollen and >1 but ≤4 tender joints; 2-8 total active joints). Patients were randomised 2:1 to apremilast 30 mg twice daily or placebo for 24 weeks, with an early escape at Week 16. The primary endpoint was the proportion of patients at Week 16 who achieved minimal disease activity (MDA)-Joints (modification of MDA mandating ≤1 swollen joint and ≤1 tender joint) based on sentinel joints (those affected at baseline) with a combination of non-responder imputation and multiple imputations. Exploratory analysis assessed all joints.
Results: Of 308 patients randomised (apremilast: n=203; placebo: n=105), mean (standard deviation [SD]) PsA duration was 9.9 (10.2) months, mean (SD) age was 50.9 (12.5) years, and 39.9% of patients were using a csDMARD. MDA-Joints (sentinel joints [primary endpoint], all joints) was achieved by significantly more patients with apremilast (33.9% and 21.3%) vs placebo (16.0% and 7.9%) at Week 16 (P=0.0008 and nominal P=0.0028, respectively). Greater improvements in patient-reported outcomes, clinical disease activity, and skin involvement also were seen with apremilast vs placebo.
Conclusions: FOREMOST is the first randomised controlled trial designed for early oligoarticular PsA and showed apremilast improves clinical and patient-reported outcomes. This trial may inform optimal management of PsA in these patients.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 528.6KB, Terms of use)
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- Publisher copy:
- 10.1136/ard-2024-225833
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- Annals of the Rheumatic Diseases More from this journal
- Volume:
- 83
- Issue:
- 11
- Pages:
- 1480-1488
- Publication date:
- 2024-08-20
- Acceptance date:
- 2024-07-25
- DOI:
- EISSN:
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1468-2060
- ISSN:
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0003-4967
- Language:
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English
- Keywords:
- Pubs id:
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2018717
- Local pid:
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pubs:2018717
- Deposit date:
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2024-07-29
- ARK identifier:
Terms of use
- Copyright holder:
- Gossec et al.
- Copyright date:
- 2024
- Rights statement:
- © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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