Keiichi Yamanaka, MD, PhD

A recent study found that efficacy for risankizumab for generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) patients was seen after 16 weeks of treatment, in addition to a strong long-term safety profile.

The relatively lower prevalence of both EP and GPP was noted as the reason for the lack of therapy developments, with the common treatments such as corticosteroids and antibiotics frequently having complications and trial data showing variable efficacy.

The study was led by Keiichi Yamanaka, MD, PhD, from the Department of Dermatology at Mie University Graduate School of Medicine in Japan.

“To date, no randomized, double-blind clinical studies have evaluated biologic treatment in patients with GPP and EP because of the limited number of patients, and evidence of the safety and efficacy of risankizumab in patients with GPP or EP is still lacking,” Yamanaka and colleagues wrote. “Here, we report the primary and long-term efficacy and safety data of risankizumab in treating Japanese patients with GPP or EP.”

Background

The study was known as IMMspire (A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis). It was reported as a randomized, open-label, phase 3 parallel design and involved 2 different treatment doses for patients.

The potential patients included in the study were age 20 or older and diagnosed with EP or GPP at least two months prior to informed consent being obtained. The patients were also each candidates for systemic or phototherapy depending on the research team’s views.

The investigators randomized the 17 total patients 1:1 and they were given subcutaneous administration of either 150 mg or 75 mg of open-label risankizumab first by week 0, then week 4, and then every 12 weeks following up until 160 weeks. The researchers’ main endpoint involved patients reporting a clinical response by 16 weeks.

Study Findings

The investigators found that every GPP and EP patient achieved clinical response by 16 weeks, as per the primary endpoint of the study. Dermatology Life Quality Index (DLQI) of 0 or 1 was reported to be achieved by almost 67% of those assessed, and this amount increased over time until all had achieved DLQI 0/1 by 160 weeks.

The investigators also noted that risankizumab’s safety profile in the IMMspire study was consistent with those of prior studies into the drug.

“Efficacy was achieved at week 16 and maintained throughout treatment, and up to the last follow-up visit,” they wrote. “The safety profile was consistent with the safety profiles outlined in other psoriasis studies with risankizumab treatment. These results suggest that risankizumab may be an effective long-term treatment option for GPP or EP.”

The study, “Efficacy and safety of risankizumab in Japanese patients with generalized pustular psoriasis or erythrodermic psoriasis: Primary analysis and 180-week follow-up results from the phase 3, multicenter IMMspire study,” was published online in the Journal of Dermatology.