Early Oligoarticular Psoriatic Arthritis Responds to Treatment With Apremilast: Week 16 Results From FOREMOST - a Phase 4 Randomized Controlled Trial
Authors: Gossec Laure , Gladman Dafna , Coates Laura , Aelion Jacob , Vasandani Jitendra , Reddy Jyotsna , Wang Rebecca , Brunori Michele , Colgan Stephen , Mease Philip 
Published: March 2024

Early Oligoarticular Psoriatic Arthritis Responds to Treatment With Apremilast: Week 16 Results From FOREMOST – a Phase 4 Randomized Controlled Trial

Laure Gossec1, Dafna Gladman2, Laura C. Coates3, Jacob Aelion4, Jitendra Vasandani5, Jyotsna Reddy6, Rebecca Wang6, Michele Brunori6, Stephen Colgan6, Philip Mease7

1Sorbonne Université and Pitié Salpêtrière Hospital, Paris, France; 2Toronto Western Hospital, Toronto, ON, Canada; 3University of Oxford, Oxford, UK; 4West Tennessee Research Institute, Jackson, TN, USA; 5West Texas Clinical Research, Lubbock, TX, USA; 6Amgen Inc., Thousand Oaks, CA, USA; 7Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, USA

Introduction & Objectives:

Psoriatic arthritis (PsA) is underdiagnosed in dermatology practice, typically presenting 10 years after skin symptoms. Dermatologists may encounter early PsA since up to 30% of patients with psoriasis have PsA. Oligoarticular PsA affects ≤4 joints, is very common, and is underrepresented in clinical trials as most pivotal studies exclude patients with <3 swollen and tender joints. Here, we report the efficacy and safety of apremilast vs. placebo for the treatment of early oligoarticular PsA.

Materials & Methods:

FOREMOST (NCT03747939) is a phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients with PsA,based on CAPSAR criteria, duration ≤5 years, swollen joint count (SJC) >1 but ≤4, and tender joint count (TJC) >1 but ≤4 were randomized 2:1 to apremilast 30 mg BID (APR) or placebo for 24 weeks. The primary endpoint was the achievement of minimal disease activity (MDA)-Joints1 (mandating SJC ≤1 and TJC ≤1, and 3/5 alternate items) at week 16.

Results:

Of 308 patients randomized (APR: n=203; placebo: n=105), mean PsA duration was 9.9 months, mean age was 50.9 years, and 39.9% of patients were using csDMARD. MDA-Joints response was achieved in 33.9% vs. 16.0% for patients treated with APR vs. placebo (primary endpoint, P=0.0008). At week 16, a significantly greater proportion, 70.2%, of patients treated with APR achieved cDAPSA REM/LDA vs. 51.8% with placebo (P=0.0017). A greater proportion of patients achieved a good/moderate response in PASDAS score with APR (59.9%) vs. placebo (42.7%). Greater improvements from baseline in PsA Impact of Disease (PsAID)-12 score (LS mean change, −1.5 vs. −0.4; nominal P<0.0001) and nail psoriasis score (visual analog scale [VAS]; LS mean change, −13.9 vs. −6.8; nominal P=0.0094) were observed with APR vs. placebo at week 16. Patients treated with APR also achieved greater improvement in quality of life measures (Patient Pain [VAS ≤15: 59.6 vs. 13.8; nominal P=0.0022], Patient Global Assessment [PtGA; VAS ≤20: 61.7 vs. 20.1; nominal P=0.0286]) when compared to placebo at week 16. No new safety signals were identified.

Conclusion:

FOREMOST is the first global randomized controlled trial exclusively studying early oligoarticular PsA. We report the first results of FOREMOST, the primary outcome, and show better disease control is achievable with APR, with twice the MDA-Joint response compared with placebo at 16 weeks. These findings show APR treatment of early oligoarticular PsA improves clinical and quality of life outcomes and may inform optimal management of these patients.

Reference: 1. Coates LC, et al. J Rheumatol. 2016;43:371–5.