Response to ritlecitinib with or without narrow-band UVB add-on therapy in patients with active nonsegmental vitiligo: results from a phase 2b extension study

Yuji Yamaguchi; Elena Peeva; Roni Adiri; Pranab Ghosh; Lynne Napatalung; Iltefat Hamzavi; Amit G Pandya; Ronald N Shore; Khaled Ezzedine; Emma Guttman-Yassky

doi:10.1016/j.jaad.2024.11.064

Response to ritlecitinib with or without narrow-band UVB add-on therapy in patients with active nonsegmental vitiligo: results from a phase 2b extension study

J Am Acad Dermatol. 2024 Dec 19:S0190-9622(24)03381-4. doi: 10.1016/j.jaad.2024.11.064. Online ahead of print.

Authors

Affiliations

¹ Pfizer Inc, Collegeville, PA, USA.
² Pfizer Inc, Cambridge, MA, USA.
³ Pfizer Pharmaceutical Israel LTD, Herzliya Pituach, Israel.
⁴ Pfizer Inc, New York, NY, USA; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁵ Department of Dermatology, Henry Ford Hospital, Detroit, MI, USA.
⁶ Palo Alto Foundation Medical Group, Sunnyvale, CA, USA; Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
⁷ Ronald N. Shore Dermatology, Rockville, MD, USA.
⁸ Department of Dermatology, Hôpital Henri Mondor, Creteil, France.
⁹ Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: emma.guttman@mountsinai.org.

PMID: 39709084
DOI: 10.1016/j.jaad.2024.11.064

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 UVB (nbUVB) phototherapy in patients with nonsegmental vitiligo.

Methods: Following a 24-week, placebo-controlled, dose-ranging period, patients received ritlecitinib 200mg for 4 weeks then 50mg for 20 weeks, with or without nbUVB phototherapy 2x/week. Missing data were handled using last observation carried forward (LOCF) 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 (%CFB) in Total-Vitiligo Area Scoring Index (T-VASI) at week 12. At week 24, mean %CFB in Facial-VASI score was -57.0 vs -51.5 (LOCF; P=0.158) and -69.6 vs -55.1 (OC; P=0.009), for ritlecitinib+nbUVB vs ritlecitinib-monotherapy, respectively. Mean %CFB in T-VASI at week 24 was -29.4 vs -21.2 (LOCF; P=0.043) and -46.8 vs -24.5 (OC; P<0.001), 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.

Keywords: JAK inhibitor; TEC inhibitor; VASI; clinical trial; nonsegmental vitiligo; ritlecitinib; skin depigmentation; vitiligo.