FDA Okays Spesolimab, First Treatment for Generalized Pustular Psoriasis

Megan Brooks

September 02, 2022

UPDATED September 6, 2022 // Editor's note: This article has been updated to include comments from the investigator.

The US Food and Drug Administration (FDA) has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the company has announced.

Until this approval, "there were no FDA-approved options to treat patients experiencing a GPP flare," Mark Lebwohl, MD, principal investigator in the pivotal spesolimab trial, told Medscape. The approval "is a turning point for dermatologists and clinicians who treat patients living with this devastating and debilitating disease," he added.

Treatment with spesolimab "rapidly improves the clinical symptoms of GPP flares and will greatly improve our ability to help our patients manage painful flares," noted Lebwohl, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Spesolimab, manufactured by Boehringer Ingelheim is a novel, selective monoclonal antibody that blocks interleukin-36 signaling known to be involved in GPP. It received priority review and had orphan drug and breakthrough therapy designation.

GPP affects an estimated 1 of every 10,000 people in the US.

Though rare, GPP is a potentially life-threatening disease that is distinct from plaque psoriasis. GPP is caused by the accumulation of neutrophils in the skin. Throughout the course of the disease, patients may suffer recurring episodes of widespread eruptions of painful, sterile pustules across all parts of the body.

Spesolimab was evaluated in a global, 12-week, placebo-controlled clinical trial that involved 53 adults experiencing a GPP flare. After 1 week, significantly more patients treated with spesolimab than placebo showed no visible pustules (54% vs 6%), according to the company.

The most common adverse reactions, seen in at least 5% of patients treated with spesolimab, were asthenia and fatigue; nausea and vomiting; headache; pruritus and prurigo; hematoma and bruising at the infusion site; and urinary tract infection.

Full prescribing information and a medication guide are available online.

Lebwohl is a paid consultant to Boehringer Ingelheim.

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