Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody used for the treatment of generalized pustular psoriasis (GPP).[4] It is an interleukin-36 receptor (IL-36R) antagonist.[4][6] It is given via injection into a vein.[4][6]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Interleukin 36 receptor (IL1RL2/IL1RAP) |
| Clinical data | |
| Trade names | Spevigo |
| Other names | BI-655130, spesolimab-sbzo |
| AHFS/Drugs.com | Monograph |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6480H9988N1736O2012S46 |
| Molar mass | 145880.08 g·mol−1 |
The most common adverse reactions include fatigue, nausea and vomiting, headache, pruritus (itching) and prurigo (itchy bumps), bruising, and urinary tract infection.[4][6]
It was approved for medical use in the United States in September 2022,[7][8][9][10] and in European Union in December 2022.[5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11][12]
Medical uses
Spesolimab is indicated for the treatment of generalized pustular psoriasis flares in adults.[4][6]
History
The US Food and Drug Administration (FDA) approved spesolimab based on evidence from a clinical trial of 53 adults with generalized pustular psoriasis flare.[6] The trial was conducted at three sites in the United States and 23 sites globally (Africa, Asia, and Europe).[6] Spesolimab was evaluated in one clinical trial (Study Effisayil-1/NCT03782792) of 53 adults with generalized pustular psoriasis flare.[6] In the trial, participants received a single treatment with either spesolimab or placebo.[6] Participants were evaluated for clearance of pustules based on a Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) pustulation sub score of 0 (indicating no visible pustules) at Week 1.[6] Neither the participant nor the healthcare providers knew which treatment was being given until after week 1.[6] After week 1, all participants, whether they initially received spesolimab or placebo, who continued to experience flare symptoms, had the option to receive a single open-label treatment of spesolimab (second treatment and first treatment for participants in the spesolimab and placebo groups, respectively).[6] After week 1 to week 12, participants in either original treatment group whose generalized pustular psoriasis flare reoccurred after achieving a clinical response were eligible to receive a single open-label rescue treatment of spesolimab, with a maximum of three total treatments of spesolimab throughout the trial.[6]
Society and culture
Legal status
In October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Spevigo, intended for the treatment of flares in adult patients with generalised pustular psoriasis.[13] The applicant for this medicinal product is Boehringer Ingelheim International GmbH.[13] Spesolimab was approved for medical use in the European Union in December 2022.[5][14]
References
External links
- Clinical trial number NCT03782792 for "Effisayil 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis" at ClinicalTrials.gov
