Response to ritlecitinib with or without narrow-band ultraviolet B add-on therapy in patients with active nonsegmental vitiligo: Results from a phase 2b extension study - 19/03/25
Abstract |
Background |
Ritlecitinib demonstrated efficacy in a phase 2b trial of nonsegmental vitiligo.
Objective |
To evaluate the efficacy and tolerability of ritlecitinib with add-on narrow-band ultraviolet B (nbUVB) phototherapy in patients with nonsegmental vitiligo.
Methods |
Following a 24-week, placebo-controlled, dose-ranging period, patients received ritlecitinib 200 mg for 4 weeks then 50 mg for 20 weeks, with or without nbUVB phototherapy 2x/week. Missing data were handled using last observation carried forward and observed case (OC).
Results |
Forty-three patients received ritlecitinib + nbUVB and 187 received ritlecitinib-monotherapy. Nine patients receiving ritlecitinib + nbUVB discontinued due to nbUVB group-specific efficacy criteria requiring >10% improvement in % change from baseline (% change from baseline) in Total-Vitiligo Area Scoring Index at week 12. At week 24, mean % change from baseline in Facial-VASI score was −57.0 vs −51.5 (last observation carried forward; P = .158) and −69.6 vs −55.1 (OC; P = .009), for ritlecitinib + nbUVB vs ritlecitinib-monotherapy, respectively. Mean % change from baseline in Total-Vitiligo Area Scoring Index at week 24 was −29.4 vs −21.2 (last observation carried forward; P = .043) and −46.8 vs −24.5 (OC; P < .001), respectively. nbUVB addition to ritlecitinib was well tolerated with no new safety signals.
Limitations |
Exploratory analysis; discontinuation criterion applied only to the ritlecitinib + nbUVB group; small sample size.
Conclusion |
Ritlecitinib alone and with nbUVB therapy improved facial and total body repigmentation and was well tolerated. Adding nbUVB may improve ritlecitinib efficacy.
Le texte complet de cet article est disponible en PDF.Key words : clinical trial, JAK inhibitor, nonsegmental vitiligo, ritlecitinib, skin depigmentation, TEC inhibitor, VASI, vitiligo
Abbreviations used : ANCOVA, BSA, CFB, CI, CXCL, F-VASI, IFN-γ, JAK, LOCF, nbUVB, NSV, OC, PGIC-V, QD, T-VASI, TEAE, TEC, VWG
Plan
| Funding sources: This study was funded by Pfizer, Inc. |
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| Previous presentation: A portion of this work was presented as an oral late-breaking presentation at the 2024 AAD Annual Meeting, March 8-12, 2024, San Diego, California. |
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| Patient consent: Consent for the publication of recognizable patient photographs or other identifiable material was obtained by the authors. All patients gave written informed consent with the understanding that this information may be publicly available. |
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| IRB approval status: The final protocol, any amendments, and informed consent documentation were approved by the institutional review board/independent ethics committee at each study center. |
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| Data sharing statement: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See trial-data-and-results for more information. |
Vol 92 - N° 4
P. 781-789 - avril 2025 Retour au numéro
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