A subcutaneous injection of the interleukin-36 receptor antagonist spesolimab may be effective at reducing flares in patients with generalized pustular psoriasis, according to a report from Medscape. Experts stressed that the disease may cause painful pustules and can lead to potentially fatal complications such as sepsis and shock, pointing to a significant need for new targeted therapies. In the phase IIb Effisayil 2 trial—presented by Lebwohl et al at the 25th WCD—123 patients were randomly assigned to receive either a high-dose regimen consisting of 600 mg of spesolimab and subsequent doses of 300 mg once every 4 weeks, a medium-dose regimen of an initial 600 mg followed by 300 mg once every 12 weeks, a low-dose regimen of an initial 300 mg followed by 150 mg once every 12 weeks, or placebo. After a follow-up of 48 weeks, researchers discovered that patients who received the high-dose regimen experienced 84% fewer flares compared with those who received placebo (hazard ratio = 0.16, 95% confidence interval = 0.05–0.54). Further, high doses of the agent proved effective at preventing flares after the 4-week period. Patients who received the high-dose regimen of spesolimab also had a reduced risk difference of –39% regarding the occurrence of flares by week 48 compared with those who received placebo. The new findings may support the use of spesolimab to mitigate flares in patients with generalized pustular psoriasis.
July 13, 2023