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Psoriatic arthritis patients displayed response to apremilast up to 1 year
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Patients with psoriatic arthritis continued to demonstrate meaningful clinical response beyond 24 weeks of apremilast treatment, according to research presented at the annual congress of the European League Against Rheumatism in Madrid.
“Over the course of their disease, patients with psoriatic arthritis may take a variety of treatment regimens over extended periods of time,” researcher Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, said in a press release. “This relatively large study suggests that apremilast [a novel, oral phosphodiesterase 4 inhibitor] has sustained efficacy and tolerability over a year among patients previously treated with [disease-modifying antirheumatic drugs] and/or other biologic agents.”
In a phase 3, multicenter, double blind parallel-group study, researchers randomly assigned 504 patients with active psoriatic arthritis to 20 mg apremilast (APR) twice daily (n=168), 30 mg APR twice daily (n=168) or placebo (n=168) for 24 weeks. Before apremilast, patients underwent 24-week therapy with disease-modifying antirheumatic drugs or biologics.
Patients with less than 20% reduction from baseline in swollen/tender joint counts at week 16 were re-randomized to APR20 or APR30. Remaining placebo patients at 24 weeks were randomly converted to APR20 or APR30 through week 52.
More APR20 (31.3%; P=.014) and APR30 (40.4%; P<.0001) patients achieved ACR20 response at week 16 compared with placebo patients (19.4%). Sixty-three percent of APR20 patients and 54.6% of APR30 patients maintained ACR20 at 1 year.
Adverse events (AEs), severe AEs and serious AEs had exposure-adjusted incidence rates that were comparable at 0-24 weeks and 0-52 weeks. Exposure up to 1 year showed no clinically meaningful laboratory findings.
“The proportion of patients remaining on APR to week 52 who first reported the most common GI disturbances (eg, diarrhea, nausea and vomiting) after week 24 was low (0.6-3% for APR20 and 0-1.8% for APR30),” the researchers reported. “Apremilast continued to be well tolerated with an acceptable longer-term safety profile.”
“These results show that apremilast may become a potential therapy for psoriatic arthritis patients,” Kavanaugh said.
Disclosure: See the abstract for a full list of relevant disclosures.
For more information:
Kavanaugh A. LB0001: Long-Term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis. Presented at: EULAR 2013; June 12-15, Madrid.