General Description

Spevigo (spesolimab-sbzo) injection is an interleukin-36 receptor antagonist. 

Spevigo is specifically indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults.

Spevigo is supplied as an injection for intravenous administration. Administer as a single 900 mg dose by intravenous infusion over 90 minutes. If flare symptoms persist, may administer an additional intravenous 900 mg dose one week after the initial dose.

Mechanism of Action

Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways. The precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.

Side Effects

Adverse effects associated with the use of Spevigo may include, but are not limited to, the following:

• asthenia and fatigue
• nausea and vomiting
• headache
• pruritus and prurigo
• infusion site hematoma and bruising
• urinary tract infection

Clinical Trial Results

The FDA’s approval of spesolimab is based on results from the pivotal EFFISAYIL 1 Phase 2 clinical trial. In the 12-week trial, patients (n=53) experiencing a GPP flare were treated with a single 900 mg intravenous dose of spesolimab or placebo. Most patients at the outset of the trial had a high, or very high, density of pustules, and impaired quality of life. After one week, 54% of patients treated with spesolimab showed no visible pustules compared to 6% of patients treated with placebo.