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Apremilast successfully treated patients with plaque psoriasis

Apremilast, at oral dosages of 20 mg or 30 mg twice daily, appeared to be effective and safe for patients with moderate to severe plaque psoriasis, according to study results.

Researchers randomly assigned 352 patients with moderate to severe psoriasis (mean age, 44.3 years; 63% men) into one of four groups in a phase 2b, multicenter trial. Patients were assigned twice-daily treatment for 24 weeks of: oral placebo (n=88), 10 mg apremilast (n=89), 20 mg apremilast (n=87) or 30 mg apremilast (n=88). The placebo group was assigned 20 mg or 30 mg apremilast twice daily at week 16 through week 24. Treatment assignments were hidden from investigators and participants for the first 16 weeks; researchers revealed that all treatment was active during weeks 16 to 24, but dose amounts were concealed.

The proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI-75) at week 16 was significantly higher in cohorts assigned 20 mg apremilast (OR=6.69; 95% CI, 2.43-18.5) or 30 mg apremilast (OR=11.5; 95% CI, 4.24-31.16) compared with placebo. The 10-mg apremilast group did not significantly differ from placebo (OR=2.10; 95% CI, 0.69-6.42). PASI-75 was achieved by 6% of the placebo group, 11% of the 10-mg apremilast group (P=.19), 29% of the 20-mg apremilast group (P<.0001) and 41% of the 30-mg group (P<.0001).

Mild or moderate adverse events were reported by at least 5% of participants at week 16. Eight serious adverse events (three in placebo and 20-mg apremilast groups, two in apremilast 30-mg group) were considered unrelated to apremilast, which also had no apparent effect on hematological, urinalysis, immunological or inflammation, serum chemistry or electrocardiographic tests.

“Our results support continuing, longer-term studies,” the researchers said. “These findings, along with oral dosing and apparent lack of need for monitoring of liver and kidney function, suggest that apremilast offers an efficacious treatment option with an acceptable safety and tolerability profile of improved convenience compared with present options and could help fill a gap in the management of psoriasis.”

Disclosure: See the study for a full list of relevant disclosures.