Sustained hair regrowth with continued ritlecitinib treatment through week 48 in patients with alopecia areata with or without early target responses: Post hoc analysis of the ALLEGRO phase 2b/3 trial - 14/11/24

Doi : 10.1016/j.jaad.2024.09.064

Melissa Piliang, MD ^a, Charles Lynde, MD ^b, Brett King, MD, PhD ^c, Paradi Mirmirani, MD ^d, Rodney Sinclair, MBBS, MD ^e, Maryanne Senna, MD ^f, Seth Forman, MD ^g, Lindsey Bordone, MD ^h, Pablo De La Cueva Dobao, MD ⁱ, Robert Wolk, MD, PhD ^j, Samuel H. Zwillich, MD ^j, Helen Tran, PharmD ^k, Dalia Wajsbrot, MSc ^k, Haytham Mohamed Ahmed, BSc ^l, Liza Takiya, PharmD ^m,^⁎
^a Department of Dermatology, Cleveland Clinic, Cleveland, Ohio
^b Department of Medicine, University of Toronto, Toronto, Ontario, Canada
^c Department of Dermatology, Yale School of Medicine, New Haven, Connecticut
^d Department of Dermatology, The Permanente Medical Group, Vallejo, California
^e Sinclair Dermatology, Melbourne, Victoria, Australia
^f Department of Dermatology, Lahey Hospital and Medical Center, Burlington, Massachusetts
^g ForCare Medical Center, Tampa, Florida
^h Department of Dermatology, Columbia University Medical Center, New York, New York
ⁱ Departamento de Dermatología, Hospital Universitario Infanta Leonor, Madrid, Spain
^j Pfizer Inc, Groton, Connecticut
^k Pfizer Inc, New York, New York
^l Pfizer Inc, Dubai, United Arab Emirates
^m Pfizer Inc, Collegeville, Pennsylvania

^∗Correspondence to: Liza Takiya, PharmD, Pfizer Inc, 500 Arcola Rd, Collegeville, PA 19426.Pfizer IncCollegevillePA

En prensa. Pruebas corregidas por el autor. Disponible en línea desde el Thursday 14 November 2024
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Abstract

Background

Few treatments for alopecia areata have demonstrated sustained efficacy.

Objective

Evaluate the efficacy and safety of continued ritlecitinib treatment to week 48 in patients with alopecia areata with or without target efficacy responses at week 24.

Methods

Patients aged ≥12 years received daily ritlecitinib (±4-week loading dose): 200/50 mg, 200/30 mg, 50 mg, or 30 mg. Patients with clinical response at week 24, based on a Severity of Alopecia Tool (SALT) score ≤20 and ≤10, were evaluated for sustained response through week 48. Nonresponders at week 24 were assessed for response through week 48.

Results

Among ritlecitinib-treated patients with SALT score ≤20 and ≤10 responses at week 24, ≥85% and ≥68%, respectively, sustained these responses through week 48. Of those with a SALT score >20 at week 24, 22% to 34% achieved a SALT score ≤20 at week 48. Of those with a SALT score >10 at week 24, 20% to 26% achieved a SALT score ≤10 at week 48. Safety was similar across subgroups.

Limitations

Small sample size.

Conclusion

Hair regrowth was sustained through week 48 in patients with response at week 24. Up to one-third of patients who did not meet target efficacy at week 24 achieved response with continued ritlecitinib treatment.

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Key words : alopecia, alopecia areata, clinical research, drug response, hair research, JAK3/TEC family kinase inhibitor, ritlecitinib, sustained response

Abbreviations used : AA, AE, AT, AU, EB, EBA, EL, ELA, JAK, SALT

Esquema

Sustained efficacy in patients with clinical response at week 24

Efficacy in patients without target clinical response at week 24

Safety

Discussion

	Funding sources: This study was funded by Pfizer Inc. Third-party medical writing assistance, provided by Hannah Humphries, PhD, and Ellen Mercado, PhD, of Nucleus Global, was funded by Pfizer Inc.
	Previous presentation: A portion of this work was presented as an oral presentation at the 2022 World Congress for Hair Research and the 2023 American Academy of Dermatology Annual Meeting; New Orleans, LA.
	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.
	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.
	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 anonymized participant data. See trial-data-and-results for more information.