Spesolimab Approved in US, China for Generalized Pustular Psoriasis in Patients 12 and Older

Boehringer Ingelheim has announced the US Food and Drug Administration (FDA) approval of spesolimab-sbzo (Spevigo) injection for generalized pustular psoriasis (GPP) treatment of patients aged 12 years and older weighing ≥40 kg.¹

The FDA approval follows recent news of the Chinese National Medical Products Administration’s (NMPA) approval of subcutaneous spesolimab treatment for GPP in the same patient population and with the same parameters.

“Until now, people living with GPP have not had any approved options to treat their disease,” Bruce Strober, MD, PhD, clinical professor of dermatology at Yale University and Central Connecticut Dermatology, said in a statement. “(Spesolimab) has the potential to redefine the treatment options for the patients we serve.”

A novel humanized selective IgG1 antibody designed to impact the interleukin-36 receptor (IL-36R), which is known to be a critical element of the body’s immune system signaling pathway that also affects GPP.

GPP is known for being a heterogeneous inflammatory neutrophilic disorder which is chronic and characterized by patients having painful symptoms on their skin as well as systemic manifestations such as fever and pain. The condition can appear persistent or relapsing courses.

Both the FDA and NMPA approvals followed the positive findings that represented the conclusion of the Effisayil 2 clinical study on spesolimab for GPP.² Effisayil 2 was a 48-week study in which 92 individuals were placed in the treatment arm—specifically, 30 were in the high dose group, 31 in medium dose, and 31 in low dose—and 31 individuals were placed in the placebo arm.

Investigators ended up finding that spesolumab led to an 84% GPP flare risk reduction compared to patients given a placebo. The trial investigators had included 123 individuals, and no flares in GPP were shown to have been reported following the 4-week mark on subcutaneous spesolimab treatment in the high-dose cohort of the study.

A notable finding was that there was a rise in incidence (≥9 cases per 100 patient-years) of reactions at injection sites, arthralgia, urinary tract infections, and itch as opposed to those in the placebo arm in Effisayil 2.

The approvals are considered by many dermatologists to be important, given that emergency medical care is frequently needed for patients with GPP, especially given the possible threat of sepsis or multi-organ failure. The chronic skin disease is impactful, with long-term life quality impacts leading to anxiety and fear among those affected.

References

1. ^{SPEVIGO® approved for expanded indications in China and the US. Boehringer Ingelheim. March 19, 2024. https://www.boehringer-ingelheim.com/us/spevigo-approved-expanded-indications-china-and-us. Date accessed: March 19, 2024.}
2. ^{Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402(10412):1541-1551. doi:10.1016/S0140-6736(23)01378-8.}