Spevigo (spesolimab-sbzo) is a first-in-class monoclonal antibody indicated for the treatment of adults with generalized pustular psoriasis (GPP) flares. GPP is a rare and potentially life-threatening autoinflammatory skin disease characterized by widespread sterile pustules, fever, and systemic inflammation.
How Spevigo Works
Spevigo works by blocking the interleukin-36 (IL-36) pathway. IL-36 is a cytokine that plays a key role in the development and progression of GPP. By blocking IL-36, Spevigo can help to reduce inflammation and improve the symptoms of GPP.
Clinical Studies
The efficacy and safety of Spevigo were evaluated in a Phase 3 clinical trial called Effisayil-1. The trial included 114 adults with GPP flares. Participants were randomized to receive either Spevigo or placebo.
The results of the trial showed that Spevigo was significantly more effective than placebo at clearing GPP flares. At 14 weeks, 93% of participants who received Spevigo had achieved complete or nearly complete clearance of their flares, compared to only 18% of participants who received placebo.
Spevigo was also well tolerated in the trial. The most common side effects were headache, fatigue, and injection site reactions.
How to Use Spevigo
Spevigo is administered as a single intravenous infusion over 90 minutes. The recommended dose is 900 mg. If GPP flare symptoms persist, an additional intravenous 900 mg dose may be administered one week after the initial dose.
Important Safety Information
Spevigo can increase the risk of serious infections, including tuberculosis. Before starting Spevigo, your doctor will test you for tuberculosis. Spevigo can also reactivate latent tuberculosis infection.
Spevigo can also increase the risk of other side effects, such as:
- Allergic reactions
- Inflammatory bowel disease (IBD)
- Psoriasis worsening
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Diarrhea
- Nausea
- Fatigue
Indications
Spevigo is indicated for the treatment of adults with GPP flares.
Precautions
Spevigo should be used with caution in patients with a history of serious infections, tuberculosis, IBD, or other autoimmune diseases.
Spevigo should not be used in patients who have a history of severe allergic reactions to Spevigo or other biologic medications.
Interactions
Spevigo may interact with other medications, including live vaccines and biologic medications. Be sure to tell your doctor about all of the medications you are taking before starting Spevigo.
Contraindications
Spevigo is contraindicated in patients with a history of severe allergic reactions to Spevigo or other biologic medications.
Overdose
There is no known overdose of Spevigo.
Side Effects
The most common side effects of Spevigo are upper respiratory tract infections, headache, diarrhea, nausea, fatigue, and injection site reactions.
More serious side effects of Spevigo include serious infections, IBD, psoriasis worsening, and allergic reactions.
If you experience any side effects while taking Spevigo, be sure to tell your doctor.
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