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.
Valeria Santoro –
After receiving Spevigo, I noticed meaningful improvements within days. The inflammation subsided, my skin continued to heal, and I finally felt like myself again. My dermatologist has been very happy with my progress, and I feel much more confident knowing there’s an effective treatment available for GPP flares. I would gladly give Spevigo five stars.
Rasmus Holm –
Spevigo exceeded all of my expectations. My flare gradually came under control, and the redness and painful pustules improved significantly. I was able to return to my normal daily routine much sooner than I had anticipated. I’m incredibly thankful for this treatment and the positive impact it has had on my recovery.
Mina El Sayed –
Living with generalized pustular psoriasis has been extremely challenging, but Spevigo has helped me through one of my worst flares. My skin became noticeably calmer, and I was finally able to sleep comfortably again. My doctor was impressed with my recovery, and I feel much more optimistic about managing future flares.
Dominic Fraser –
My GPP flare was overwhelming, but Spevigo gave me hope. After treatment, my skin began improving much sooner than I expected, and the pain and discomfort steadily decreased. My healthcare team closely monitored my recovery, and every follow-up visit has been encouraging. This medication has been a true blessing.
Anastasia Georgiou –
Spevigo made an incredible difference during one of my generalized pustular psoriasis flares. The painful pustules and inflammation gradually improved, and I finally started feeling comfortable again. My dermatologist was very pleased with how well I responded to treatment. I’m extremely grateful that this medication was available when I needed it.