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Study: Apremilast linked with improved clinical outcomes in patients with psoriatic arthritis
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Patients with psoriatic arthritis treated with apremilast had clinical improvements for outcomes — including signs and symptoms, physical function and psoriasis — for up to 13 months, according to results.
Researchers randomly assigned 484 patients with psoriatic arthritis to receive apremilast 20 mg twice daily, apremilast 30 mg twice daily or placebo. Researchers re-randomized patients in the placebo group to apremilast 20 mg or apremilast 30 mg at week 16, while patients initially randomized to an apremilast group continued their initial dose. Patients with swollen and tender joint count improvement of less than 20% at week 16 entered early escape, researchers noted. Finally, researchers re-randomized any patients remaining on placebo at week 24 to apremilast 20 mg or apremilast 30 mg. The proportion of patients achieving greater than ACR20 at 16 weeks was the primary endpoint, according to researchers.
Results showed more patients in the apremilast 20-mg or apremilast 30-mg group achieved ACR20 by week 16 vs. placebo. Through week 52, patients in the apremilast groups had clinically meaningful improvements in signs and symptoms of psoriatic arthritis, physical function and psoriasis, according to results. Researchers noted diarrhea, nausea, headache and upper respiratory tract infection were the most common adverse events. Researchers also found infrequent and transient laboratory abnormalities. – by Casey Tingle
Disclosures: Cutolo received research grants or consulting fees from Actelion, Bristol-Myers Squibb, Mundipharm and Sanofi-Aventis. Please see the full study for a list of all other authors’ relevant financial disclosures.
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