Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 450 mg/7.5 mL (60 mg/mL)) |
| Drug Class | Interleukin-36 receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
Summary
- Spesolimab (Spevigo) is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older, weighing at least 40 kg. It targets the IL36 receptor, offering a specific approach to GPP management.
- Two systematic reviews/meta-analyses provided information on this drug's safety profile and efficacy in managing GPP flares. However, these studies highlighted a gap in long-term data regarding flare-up prevention.
- The first study recognized GPP as distinct from plaque psoriasis with no specific treatment guidelines until the advent of Spesolimab. This study emphasized its strong performance but called for further research into its long-term safety and outcomes.
- The second study was a network meta-analysis comparing the performance of biologics in treating palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP). While Secukinumab showed high efficacy for PP, none of the treatments significantly outperformed placebo based on PPPPGA scores for PPP.
- In terms of comparative positioning against other drugs like Secukinumab or Guselkumab used to treat similar conditions such as PP/PPP, direct comparisons are challenging due to a lack of head-to-head trials involving Spevigo specifically against these drugs within these conditions.
- Both studies independently suggest that while current evidence supports the efficacy of newer biologics, including Spesolimab (Spevigo), there is a considerable need for more comprehensive studies focusing on understanding the full potential across varied patient populations over longer periods.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Spevigo (spesolimab-sbzo) prescribing information. | 2024 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative efficacy of biologics and oral agents in palmoplantar psoriasis and palmoplantar pustulosis: a systematic review and network meta-analysis of randomized clinical trials. | 2023 | Journal of the American Academy of Dermatology |
| Efficacy and safety of spesolimab for the management of generalized pustular psoriasis: a drug safety evaluation. | 2023 | Expert opinion on Drug Safety |
| Small-molecule inhibitors and biologics for palmoplantar psoriasis and palmoplantar pustulosis: a systematic review and network meta-analysis. | 2023 | American Journal Of Clinical Dermatology |