Apremilast improves joint response vs placebo in early oligoarticular psoriatic arthritis
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SAN DIEGO — Apremilast is superior to placebo regarding joint response and disease control in patients with early oligoarticular psoriatic arthritis, according to data presented at ACR Convergence 2023.
“One of the things we know about apremilast [Otezla, Amgen] is its efficacy is more modest than some of the blockbuster drugs we have,” Philip J. Mease, MD, of Swedish Medical Center/Providence St. Joseph Health, and the University of Washington School of Medicine, Seattle, told Healio. “However, this is balanced with pristine safety profile.”
That said, Mease acknowledged that there are some tolerability issues with apremilast.
“We see nausea, diarrhea and vomiting in the first several weeks until patients get used to it,” he said. “These events tend to resolve.”
To analyze the efficacy of apremilast in patients with early oligoarticular PsA, Mease and colleagues conducted FOREMOST, a phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. The researchers enrolled a total of 308 patients with a PsA disease duration of no more than 5 years and limited joint involvement, defined as between two and four swollen and tender joints. Among these patients, 203 were randomly assigned to apremilast, while 105 received placebo.
The primary endpoint was the proportion of patients who achieved minimal disease activity (MDA) at week 16. MDA was defined as a swollen and total joint count of no more than 1, as well as 3/5 alternate items. Other outcomes of interest included Clinical Disease Activity in Psoriatic Arthritis (cDAPSA) remission, low disease activity, a Patient’s Global Assessment of Disease Activity (PtGA) score of 20 or less, a patient assessment of pain score of 15 or less, a Psoriatic Arthritis Disease Activity Score (PASDAS) good or moderate response, and change from baseline in Psoriatic Arthritis Impact of Disease 12-item (PsAID-12).
Included patients had a mean age of 50.9 years (SD, 12.5) and the mean PsA duration was 9.9 months (standard deviation, 10.2). In addition, 30.9% of the cohort were using a conventional synthetic disease-modifying antirheumatic drug.
According to the researchers, 33.9% of patients in the apremilast group, and 16% of those in the placebo group, achieved the primary endpoint at week 16 (P = .0008). Mease and colleagues added that a “significantly greater” proportion of patients in the study drug group reached secondary endpoints compared with placebo.
A post-hoc analysis of patients with two to four impacted joints at baseline showed that joint MDA was reported in 34.3% of patients receiving apremilast, vs. 17% of those receiving placebo. Moreover, patients in the placebo group progressed to a joint count greater than four through week 16, while no patients in the apremilast group progressed to this designation.
The researchers observed no new safety signals, Mease said.
An important component of this study is that participants had oligoarticular disease, he said.
“We really have not done trials specifically to see if patients with oligoarticular PsA respond differently to different treatments,” Mease said. “Our results showed that, yes, apremilast was more effective at treating oligoarticular patients.
“This study teaches us that early use of apremilast can benefit patients with oligoarticular disease,” he added. “We should not wait until a patient has had multiple drug failures before we try this one.”
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Mease PJ. Abstract 1691. Presented at: ACR Convergence 2023; Nov. 10-15, 2023; San Diego (hybrid meeting).
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