Apremilast in early oligoarticular PsA: phase 4 study results

The first-ever global randomised controlled trial with participants with early oligoarticular psoriatic arthritis (PsA) showed that apremilast achieved better disease control than placebo. The modified minimal disease activity score (MDA-Joints) response at 16 weeks was twice as high in the actively treated group. More participants with a joint count ≤4 at baseline shifted to a joint count of >4 with placebo.

Oligoarticular PsA can have a significant impact on the quality of life despite limited joint involvement, said Dr Philip Mease (University of Washington, WS, USA). He presented the results of the phase 4 FOREMOST study (NCT03747939), which evaluated apremilast efficacy in participants with limited joint involvement, defined as 2–4 swollen and 2–4 tender joints of 66–68 joints assessed.

The 308 participants had a disease duration of ≤5 years and were randomised 2:1 to apremilast (n=203) or placebo (n=105) for 24 weeks, with an early escape at week 16. The primary endpoint was the proportion of participants who achieved MDA-Joints. The mean age was 51 years; 40% were using a conventional synthetic disease-modifying antirheumatic drug (csDMARD), and the mean disease duration was 9.9 months, which made this one of the earliest PsA populations to have ever been studied in a randomised trial.

In the overall population, the MDA-Joints response at week 16 was twice as high in the apremilast group (33.9%) than in the placebo group (16.0%) (treatment difference of 18.5%; 95% CI 8.9-28.1; P=0.0008). Additionally, secondary endpoints at week 16 also favoured apremilast, including the proportion of participants achieving Clinical Disease Activity in Psoriatic Arthritis (cDAPSA) remission or low disease activity (70.2% vs 51.8%; P=0.0017) and Psoriatic Arthritis Disease Activity Score (PASDAS) good or moderate response (59.9% vs 42.7%; P=0.0043). The mean swollen joint count (1.2 vs 2.2) and the tender joint count (2.9 vs 5.5) were lower in the bariticinib group, as well as the Patient's Global Assessment of Disease Activity (PtGA) (48.4% vs 28.9%; P=0.0011).

In a post hoc analysis, similar MDA-Joints response rates were seen in the subgroup of 268 participants with 2–4 joints involved at baseline compared with the overall study population at week 16. Treatment-emergent adverse events were consistent with the known safety profile of apremilast. No new safety signals emerged.

1. Mease P, et al. 16-Week results from FOREMOST, a placebo-controlled study involving oligoarticular psoriatic arthritis treated with apremilast. 1691, ACR Convergence 2023, 10–15 November, San Diego, USA.

Medical writing support was provided by Michiel Tent.
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Posted on 1 December, 20231 December, 2023