Rapid and sustained improvements in Generalized Pustular Psoriasis Physician Global Assessment scores with spesolimab for treatment of generalized pustular psoriasis flares in the randomized, placebo-controlled Effisayil 1 study - 20/06/23
, Mark G. Lebwohl, MD b, Milan J. Anadkat, MD c, Jonathan Barker, MD d, Kamran Ghoreschi, MD e, Shinichi Imafuku, MD f, Ulrich Mrowietz, MD g, Ling Li, MSc h, Manuel Quaresma, Lic i, Christian Thoma, MD j, Hervé Bachelez, MD k, lAbstract |
Background |
Effisayil 1 was a randomized, placebo-controlled study of spesolimab, which is an anti-IL-36 receptor antibody, in patients presenting with a generalized pustular psoriasis flare.
Objective |
To assess the effects of spesolimab over the 12-week study.
Methods |
The primary endpoint of the study was Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 at week 1. Patients (N = 53) were randomized (2:1) to receive a single intravenous dose of 900 mg spesolimab or placebo on day 1. Patients could receive open-label spesolimab for persistent flare symptoms on day 8.
Results |
Most patients receiving spesolimab achieved a GPPGA pustulation subscore of 0 (60.0%) and GPPGA total score of 0 or 1 (60.0%) by week 12. In patients randomized to placebo who received open-label spesolimab on day 8, the proportion with GPPGA pustulation subscore of 0 increased from 5.6% at day 8 to 83.3% at week 2. No factors predictive of spesolimab response were identified in patient demographics or clinical characteristics.
Limitations |
The effect of initial randomization was not determined conventionally beyond week 1 due to patients receiving open-label spesolimab.
Conclusion |
Rapid control of generalized pustular psoriasis flare symptoms with spesolimab was sustained over 12 weeks, further supporting its potential use as a therapeutic option for patients.
Il testo completo di questo articolo è disponibile in PDF.Key words : GPP, GPPGA, IL-36, IL-36R, pustular psoriasis, spesolimab
Abbreviations used : CGI, GPP, GPPGA, IL, ITT, MCID, OL, PASI
Mappa
| Funding sources: The study was supported and funded by Boehringer Ingelheim. |
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| IRB approval status: Study protocol approved at each study site and/or country. |
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| Reprints not available from the authors. |
Vol 89 - N° 1
P. 36-44 - luglio 2023 Ritorno al numero
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