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INTERLEUKIN-36 RECEPTOR ANTAGONIST
Spevigo (spesolimab-sbzo) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat generalized pustular psoriasis (GPP) in adults and children ages 12 and older who weigh at least 40 kilograms.
Spevigo is a monoclonal antibody, a lab-made protein that helps block a target in the immune system.
Spevigo blocks the interleukin-36 receptor (IL-36R), which is involved in inflammation. The exact way reduced IL-36R activity helps treat GPP flares is not fully known.
Doctors prescribe Spevigo when adults and children ages 12 and older who weigh at least 40 kilograms need treatment for GPP.
When a person is not having a GPP flare, Spevigo is given as an injection under the skin. With proper training, people ages 12 and older or their caregivers may give these injections.
When a person is having a GPP flare, Spevigo is given as an intravenous (IV) infusion. An IV infusion means the medicine is given into a vein. IV Spevigo must be given by a healthcare professional in a healthcare setting.
The recommended dose of Spevigo for GPP differs depending on whether a person is having a flare.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of Spevigo for GPP, the most common side effects differed depending on whether the medicine was used during a flare or when a person was not having a flare.
Side effects during a flare include:
Side effects when not having a flare include:
Spevigo can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
LEO Pharma offers the SPEVIGO Copay Program through the SPEVIGO Patient Support Program. Eligible people with commercial insurance may pay as little as $0.
The SPEVIGO Patient Support Program also offers help understanding insurance coverage, exploring potential financial assistance options, and accessing educational resources and personalized support for GPP.
To learn more, visit the Spevigo Savings & Support Programs page or call 833-773-8446.
Before starting Spevigo, your doctor will test for active or latent (hidden) TB infection.
Before starting Spevigo, you should be up to date on all vaccines that are right for your age. Do not get live vaccines during treatment with Spevigo or for at least 16 weeks after treatment.
Tell your doctor if you have any allergies to spesolimab-sbzo or any ingredients in Spevigo.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Tell your doctor if you have an infection, a long-term infection, or infections that keep coming back.
Do not receive Spevigo if you have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in Spevigo.
If you miss a dose, use it as soon as possible. Then go back to your regular dosing schedule.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Spevigo, talk with your doctor about the risks and benefits.
These answers are fact-checked by our editorial staff.
How effective is Spevigo for GPP?
In a study of adults having a GPP flare, 54 percent of people who received one 900-milligram IV dose of Spevigo had no visible pustules at week 1. This was compared with 6 percent of people who received placebo (an inactive treatment).
In another study, Spevigo was studied in people with a history of GPP flares who were not having a flare at the start of treatment. By week 48, 10 percent of people taking Spevigo by injection under the skin had at least one GPP flare, compared with 52 percent of people who received placebo.
These results show that Spevigo helped clear pustules during a flare and helped reduce the chance of future flares in these studies.
How long does Spevigo take to work for GPP?
It depends on whether Spevigo is being used during a GPP flare or when a person is not having a flare.
For a GPP flare, Spevigo was studied as one 900-milligram IV dose. At week 1, 54 percent of people who received Spevigo had no visible pustules, compared with 6 percent of people who received placebo.
For people who were not having a flare, Spevigo was studied to determine whether it helped reduce future GPP flares. By week 48, 10 percent of people taking Spevigo had at least one GPP flare, compared with 52 percent of people taking placebo.
These are study assessment points rather than a guaranteed timeline for an individual response. Spevigo may work differently for each person, and your healthcare provider can tell you what to expect based on your treatment plan.
Should I receive Spevigo for GPP if I have an infection?
Spevigo may increase the risk of infections.
Treatment with Spevigo is not recommended if you have a clinically important active infection. The infection should resolve or be adequately treated before treatment with Spevigo.
Tell your healthcare provider if you have signs or symptoms of an important infection during or after treatment with Spevigo.
On MyPsoriasisTeam, people share their experiences with generalized pustular psoriasis, get advice, and find support from others who understand.
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