Apremilast (Otezla) has shown efficacy in treating early oligoarticular psoriatic arthritis (PsA), according to results from the FOREMOST trial. The study, which involved over 300 patients, found that a significantly higher proportion of patients treated with apremilast achieved minimal disease activity (MDA) in their sentinel joints compared to those receiving placebo after 16 weeks.
FOREMOST Trial Details
The FOREMOST trial, a randomized controlled study, evaluated the effectiveness of apremilast in patients with early oligoarticular PsA. Participants had at least one swollen and one tender joint, but no more than four of either. The trial initially capped disease duration at 2 years, later extended to 5 years to facilitate recruitment. Patients could continue using methotrexate or sulfasalazine if already on these medications, and stable doses of corticosteroids and non-steroidal anti-inflammatory drugs were permitted. Exclusion criteria included prior use of biologic agents, Janus kinase inhibitors, or three or more traditional disease-modifying antirheumatic drugs (DMARDs).
Primary and Secondary Endpoints
The primary endpoint was MDA in sentinel joints at week 16, defined as having a maximum of one swollen and one tender joint. Secondary outcomes included MDA across all joints, clinical remission, low disease activity (LDA), patient pain ratings, and overall response assessments by both patients and physicians. Remission was defined as a Clinical Disease Activity in Psoriatic Arthritis (cDAPSA) score of 4 or less, and LDA as a score between 4 and 13.
Key Findings
At 16 weeks, 33.9% of patients on apremilast achieved MDA in sentinel joints, compared to 16.0% in the placebo group. When considering all joints, MDA rates were 21.3% with apremilast versus 7.9% with placebo. All secondary outcomes significantly favored apremilast. Specifically, 60% of the apremilast group achieved remission or LDA, compared to 38% in the placebo group (P < 0.001). Additionally, a combined physician and patient global response assessment showed that approximately 60% of the apremilast group had good/moderate responses, versus 40% in the placebo group (P = 0.001).
Safety Profile
The safety profile of apremilast was consistent with previous studies. Treatment-emergent adverse events were more frequent in the apremilast group, primarily due to increased rates of diarrhea and nausea. Two patients in the apremilast group died during the study, but investigators determined the deaths were not treatment-related.
Clinical Implications
These results suggest that early intervention with apremilast may be beneficial for patients with oligoarticular PsA, potentially minimizing disease progression and improving quality of life. The findings from the FOREMOST trial may inform clinical management strategies for these patients, although further research is needed to confirm these benefits and explore long-term outcomes. As Laure Gossec, MD, PhD, of Sorbonne Université in Paris, and colleagues noted, up to half of all PsA patients have the oligoarticular form of the disease, which, despite being less severe, can significantly impact quality of life.
