Apremilast improves palmoplantar pustulosis in phase 2 trial
BOSTON — A phase 2 trial found Japanese patients with palmoplantar pustulosis treated with apremilast showed significant and early improvement, according to a poster presented at the American Academy of Dermatology Annual Meeting.
“For clinicians, palmoplantar pustulosis (PPP) is a condition where it’s challenging and there have been limited treatment options,” Shauna Jardon, PharmD, Amgen’s Global Medical Director for Otezla (apremilast), told Healio.
The phase 2, randomized, placebo-controlled study enrolled 90 patients who were randomly assigned 1:1 to receive 30 mg of oral apremilast twice daily or placebo for 16 weeks.
At week 16, 78.3% of patients in the treatment group achieved an improvement of at least 50% in PPP Area and Severity Index (PPPASI-50), compared with 40.9% of those in the placebo group.
The median time to PPPASI-50 was also quicker in the apremilast group (4.1 weeks; 95% CI, 4-6.1) compared with placebo (11.9 weeks; 95% CI, 8.1-14.1).
An improvement in Palmoplantar Severity Index (PPSI) of –4.2 was recorded in the apremilast group and –2.6 in the placebo group, while a mean pruritus Visual Analog Scale (VAS) change of –27.5 was reported in the treatment group compared with –7.2 in the placebo group.
The mean pain VAS improved –26.3 in the treatment cohort and –10.2 in the placebo group.
“These data are highly promising as Otezla shows significant efficacy vs. placebo in reducing the palmoplantar pustulosis disease severity and the debilitating symptoms such as burn and itching, which are so burdensome for these patients,” Jardon said. “Based on these results, our phase 3 trial is already underway and for clinicians, Otezla would be a therapeutic option with a unique mechanism of action, established safety profile and a convenient, oral route of administration.”