乌鸦传媒

The FDA has approved the monoclonal antibody spesolimab (Spevigo) as the first treatment for generalized pustular psoriasis (GPP), Boehringer Ingelheim .

The approval stipulates use of the drug to treat GPP flares in adults. Spesolimab inhibits activation of the interleukin-36 receptor to interfere with inflammatory processes that drive GPP.

"GPP flares can greatly impact a patient's life and lead to serious, life-threatening complications," said Mark Lebwohl, MD, of the Icahn School of Medicine at Mount Sinai in New York City, in a statement from the sponsor. "The approval of Spevigo is a turning point for dermatologists and clinicians. We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares."

Support for the approval came from the phase II placebo-controlled EFFISAYIL 1 trial. One week after receiving a single injection of spesolimab, 54% of patients had complete clearance of pustules as compared with 6% in the placebo group. Adverse events occurred in a majority of patients in both groups, including infections in 17% of spesolimab-treated patients and 6% of the placebo arm during the first week of treatment. Serious adverse events occurred in 6% of the spesolimab group. At week 12, infections were reported in 47% of patients who received spesolimab at any time in the trial (including placebo patients who crossed over).

In contrast to plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disorder. Characterized by widespread eruption of painful sterile pustules, GPP can occur as a relapsing or persistent condition. Flare frequency varies from patient to patient and may be spontaneous or triggered by infection, stress, medication, or pregnancy. The eruptions may be accompanied by pain, fever, malaise, fatigue, and extracutaneous manifestations such as arthritis and neutrophilic cholangitis.

GPP-associated mortality ranges from 2-16%, often attributed to septic shock or cardiorespiratory failure.

Results with spesolimab in the EFFISAYIL 1 trial were "truly remarkable," Joel Gelfand, MD, of the University of Pennsylvania in Philadelphia, told 乌鸦传媒 following publication of the results in the New England Journal of Medicine late last year. "Spesolimab offers a tremendous step forward for our patients."

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