Spesolimab beneficial for prevention of generalized pustular psoriasis flares: Effisayil 2 trial
USA: New late-breaking data from the Effisayil 2 trial revealed an 84% reduction in the risk for generalized pustular psoriasis (GPP) flares with Spesolimab over the course of 48 weeks compared to placebo.
Additionally, no flares were observed after week 4 of spesolimab treatment in the high-dose group among 123 trial participants.
The pharmaceutical company Boehringer Ingelheim presented findings from the EFFISAYIL 2 trial, the largest and the first multinational, randomized clinical trial evaluating treatments for the prevention of GPP flares, at the 25th World Congress of Dermatology (WCD).
“These results provide further compelling clinical evidence for the role IL-36 signalling plays in the GPP pathogenesis,” Bruce Strober, MD, PhD, Clinical Professor, Dermatology at Yale University, said in a statement. “Moving forward, we hope that dermatologists not only have a specific treatment for GPP flares but that we can effectively prevent them in the future.”
Flares in GPP patients are characterized by papules on the body, which are known to be painful and frequently lead to emergency care, in addition to causing near-fatal complications such as organ failure, sepsis, and shock. The uncertainty GPP patients live with regarding the possible effects of their next flare that might occur can emotionally burden patients in a substantial way.
Spesolimab, an approved GPP flare treatment, is a novel, humanized, selective antibody known to block the activation of the interleukin-36 receptor (IL-36R). This signalling pathway in the body’s immune system is involved in autoinflammatory disease pathogenesis.
"Through our comprehensive EFFISAYIL clinical program, we have already delivered spesolimab as a major advancement for flaring GPP patients," Carinne Brouillon, Head of Human Pharma at Boehringer Ingelheim, said in a statement. "The EFFISAYIL 2 trial results build on this success bringing us closer to achieving our ultimate goal of a flare-free future for everyone living with GPP."
The phase 2 trial, EFFISAYIL 1, revealed that administering a solitary intravenous infusion of spesolimab led to swift alleviation of pustular and skin symptoms in those experiencing flares.
These findings were essential in obtaining regulatory approval for spesolimab, which became the pioneering targeted therapy for managing such flares in adult patients.
In the EFFISAYIL 2 trial, spesolimab was shown to have a favourable safety profile, with a similar incidence of patients with adverse events across spesolimab and placebo treatment arms.
Spesolimab has recently received Breakthrough Therapy Designation (BTD) from the U.S. FDA (Food and Drug Administration) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as an investigational treatment for the prevention of GPP flares.
