A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results - 08/07/21
, Emma Guttman-Yassky, MD b, Elena Peeva, MD c, Anindita Banerjee, PhD c, Rodney Sinclair, MD d, Ana B. Pavel, PhD b, Linda Zhu, MD, PhD c, Lori Ann Cox, DO e, Brittany Craiglow, MD a, f, Linda Chen, MPH, MPA g, Christopher Banfield, PhD c, Karen Page, PhD c, Weidong Zhang, PhD c, Michael S. Vincent, MD, PhD cAbstract |
Background |
Alopecia areata (AA) is an autoimmune form of hair loss with limited treatments.
Objective |
To evaluate the efficacy and safety of the Janus kinase inhibitors ritlecitinib and brepocitinib in patients who have AA with ≥ 50% scalp hair loss.
Methods |
Patients were randomized to once-daily ritlecitinib, brepocitinib, or placebo. The primary efficacy endpoint was a 24-week change from baseline in the Severity of Alopecia Tool (SALT) score. The key secondary efficacy endpoint was the proportion of patients achieving 30% improvement in SALT score (SALT30).
Results |
The ritlecitinib, brepocitinib, and placebo groups included 48, 47, and 47 patients, respectively. At week 24, least-squares mean difference from placebo in SALT score change from baseline was 31.1 (95% confidence interval [CI], 18.8-43.5) for ritlecitinib and 49.2 (95% CI, 36.6-61.7) for brepocitinib (P < .0001 for both comparisons with placebo). SALT30 was achieved by 50% (90% CI, 38%-62%) of patients receiving ritlecitinib, 64% (90% CI, 51%-75%) receiving brepocitinib, and 2% (90% CI, 0%-9%) receiving placebo. Two patients experienced a serious adverse event (rhabdomyolysis) in the brepocitinib group only.
Limitations |
Only a single-dosage regimen of each study drug was included.
Conclusion |
Treatment with ritlecitinib or brepocitinib for 24 weeks was efficacious and generally well tolerated.
El texto completo de este artículo está disponible en PDF.Key words : alopecia areata, brepocitinib, efficacy, Janus kinase inhibitor, phase 2, ritlecitinib, safety
Abbreviations used : AA, AASIS, AE, AT, AU, CI, IC50, IL, IFN, IGA, IP-10, JAK, QD, SALT, TEC, TYK2, ULN
Esquema
| Drs King and Guttman-Yassky contributed equally to this article. |
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| Funding sources: The study was funded by Pfizer. Pfizer designed the study in consultation with all authors and Pfizer collected the data. All authors had full access to the data and participated in data analysis and interpretation and in writing the report. The corresponding author had final responsibility for the decision to submit for publication. |
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| IRB approval status: The ethics committee or institutional review board at each participating center approved the study protocol and all patients provided written informed consent. |
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| Reprints not available from the authors. |
Vol 85 - N° 2
P. 379-387 - août 2021 Regresar al número
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