medwireNews: Results of the phase IIIB ACTIVE trial suggest that the phosphodiesterase 4 inhibitor apremilast is superior to placebo for the treatment of psoriatic arthritis (PsA), and the benefits are seen after 2 weeks of treatment.
As reported in the Annals of the Rheumatic Diseases, patients with active PsA who had not received prior biologic treatment were randomly assigned to take oral apremilast 30 mg or placebo twice daily.
Approximately 70% of participants had received prior treatment with conventional synthetic DMARDs, which were discontinued at least 1 day before study entry. Patients were able to continue treatment with corticosteroids or nonsteroidal anti-inflammatory drugs throughout the study, which were taken by approximately 12% and 70% of patients, respectively.
At the 2-week follow-up, a significantly higher proportion of the 110 patients given apremilast achieved at least a 20% improvement in ACR criteria (ACR20) from baseline compared with the 109 patients receiving placebo, at 16.4% versus 6.4%.
ACR20 response rates at week 16 – the primary endpoint – were significantly higher among patients receiving apremilast versus placebo, at 38.2% versus 20.2%. At this timepoint, placebo-treated patients who did not experience a 10% or greater improvement in swollen and tender joint counts were switched to apremilast.
The remainder of participants continued to receive their original treatment allocation for 24 weeks, after which time all patients received apremilast until the 1-year follow-up.
The ACTIVE (Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients With Psoriatic Arthritis) investigators, led by Peter Nash (University of Queensland, Brisbane, Australia), also observed significant improvements in measures of disease activity, morning stiffness, and enthesitis at weeks 2 and 16 among patients treated with apremilast versus placebo, and these improvements were maintained until the 1-year follow-up.
Speaking to medwireNews, Medicine Matters editorial board member Oliver FitzGerald (St Vincent’s University Hospital, Dublin, Ireland) said the trial results demonstrated that “[a]premilast is effective as monotherapy in patients with psoriatic arthritis early in disease.”
He noted that less than 40% of apremilast-treated patients achieved an ACR20 response at week 16, which, based on recent trials of anti-tumor necrosis factor agents or interleukin-17 inhibitors, may be “somewhat inferior to what you might expect in a biologic agent,” and may suggest that the efficacy of apremilast lies somewhere between that of methotrexate and biologic agents.
However, in the absence of head-to-head trials, we do not know “where to place apremilast in the treatment algorithm for patients with psoriatic arthritis,” he added.
Nash and colleagues report that the overall incidence of adverse events was “generally similar” between patients receiving apremilast and those given placebo, at 67.0% versus 63.3% at week 24, noting that “[n]o new safety concerns were observed.”
Diarrhea was the most frequently occurring adverse event during the placebo-controlled part of the trial, affecting 14.7% of patients given apremilast and 11.0% of those in the placebo group. A total of 10 and five patients, respectively, discontinued treatment due to adverse events between baseline and week 24.
Over the full study duration, the adverse event profile was “comparable with longer apremilast exposure,” say Nash and colleagues.
FitzGerald noted that the adverse effects observed in this study were “what you would have expected given the previous publications,” and that “there were no surprises.”
And the researchers conclude that, when taken together with the results of the four PALACE studies, the ACTIVE findings “further support apremilast as a treatment option for patients with PsA across the spectrum of treatment experiences.”
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