For the treatment of palmoplantar pustulosis resistant to conventional therapies, guselkumab appeared safe and effective, according to recent findings.
In a double-blind, randomized, placebo-controlled, parallel-group, 24-week trial, researchers evaluated 35 patients with moderate to severe palmoplantar pustulosis (PPP) who were resistant to conventional treatments. Most patients were women (71%), and median age was 52 years (range, 28-77). Conventional treatments included topical corticosteroids, vitamin D3 analogues, etretinate, and phototherapy. Eligible patients also had active lesions at both screening and at study baseline, and had a palmoplantar pustulosis severity index score of 7 or greater.
Tadashi Terui, MD, PhD, of the Nihon University School of Medicine in Tokyo, and colleagues conducted the study between May 14, 2013, and September 27, 2014, at 11 Japanese sites. They randomly assigned patients 1:1 to receive treatment with subcutaneous guselkumab (Tremfya, Janssen) 200 mg or placebo at weeks 0 and 4.
subscores at week 24 and PPP area and severity index (PPPASI) total score at weeks 16 and 24.
Researchers tested serum IL-17A and IL17F cytokine levels at baseline, week 4 and week 16. They assessed safety through week 24 and included measures including treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, injection site reactions, and allergic reactions.
The researchers observed that guselkumab-treated patients showed significant improvements in mean PPSI total scores (–3.3) vs. placebo (–1.8) (least square mean difference, –1.5; 95%CI, –2.9 to 0.2).
At week 16, there were significant improvements in PPP area and severity index scores (least squares mean difference, –5.65; 95% CI, –9.8 to 1.5) and percentage of patients to achieve PPPASI-50 (difference in proportion, 39.2; 95% CI, 14-64.3).
Compared with placebo, the guselkumab group had a higher percentage of patients with a physician’s global assessment score of 1 or less. The guselkumab group maintained a greater decrease in mean PPSI total score from week 16 though week 24. At weeks 4 and 16, there were significant decreases from baseline in serum levels of IL-17A and IL-17F cytokines. The two groups demonstrated comparable prevalence of treatment-emergent adverse events (guselkumab group, 19 of 25 patients [76%] vs. placebo group, 18 of 24 patients [75%]). The frequent adverse effects observed included nasopharyngitis (n = 14, 29%), headache (n = 3, 6%) contact dermatitis (n = 3, 6%) and injection site erythema (n = 3, 6%). Researchers did not observe any major safety concerns during the study.
“Overall, guselkumab demonstrated therapeutic potential in Japanese patients with moderate to severe PPP,” the researchers wrote. “Long-term, phase 3 studies with placebo crossover design and continued maintenance dosing in larger patient populations are required to further characterize the therapeutic benefit of guselkumab for the treatment of PPP.” – by Jennifer Byrne
Disclosures: Terui reports research support from and performing consulting work for Janssen Pharmaceutical K.K.