A randomized, double-blind, placebo-controlled phase II study to evaluate the efficacy and safety of ivarmacitinib (SHR0302) in adult patients with moderate-to-severe alopecia areata - 10/10/23
Abstract |
Background |
Alopecia areata (AA) is a CD8+ T cell–mediated autoimmune disease characterized by nonscarring hair loss. Ivarmacitinib, which is a selective oral Janus kinase 1 inhibitor, may interrupt certain cytokine signaling implicated in the pathogenesis of AA.
Objective |
To evaluate the efficacy and safety of ivarmacitinib in adult patients with AA who have ≥25% scalp hair loss.
Methods |
Eligible patients were randomized 1:1:1:1 to receive ivarmacitinib 2, 4, or 8 mg once daily or placebo for 24 weeks. The primary end point was the percentage change from baseline in the Severity of Alopecia Tool score at week 24.
Results |
A total of 94 patients were randomized. At week 24, the least squares mean difference in the percentage change from baseline in the Severity of Alopecia Tool score for ivarmacitinib 2, 4, and 8 mg and placebo groups were −30.51% (90% CI, −45.25, −15.76), −56.11% (90% CI, −70.28, −41.95), −51.01% (90% CI, −65.20, −36.82), and −19.87% (90% CI, −33.99, −5.75), respectively. Two serious adverse events—follicular lymphoma and COVID-19 pneumonia—were reported.
Limitations |
A small sample size limits the generalizability of the results.
Conclusion |
Treatment with ivarmacitinib 4 and 8 mg doses in patients with moderate and severe AA for 24 weeks was efficacious and generally tolerated.
Le texte complet de cet article est disponible en PDF.Key words : AA, alopecia, alopecia areata, ARQ-252, ARQ-255, autoimmune disease, efficacy, hair loss, ivarmacitinib, JAK, JAK1, JAK inhibitor, Janus kinase inhibitor, phase 2, safety, SHR0302
Abbreviations used : AA, AE, AT, AU, JAK, LSM, SAE, SALT
Plan
| Funding sources: This study was funded by Reistone Biopharma Co, Ltd. |
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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. Participating centers and IKB approval numbers are as follows: Centers and Peking University People's Hospital, Beijing, China (2020PHA012-001); Jiangsu Province Hospital, The First Affiliated Hospital with Nanjing Medical University, China (2020-MD-172); China-Japan Friendship Hospital, China (2020-58-Y22) The First Affiliated Hospital, College of Medicine, Zhejiang University, China (2020伦审第241）号); Beijing Tongren Hospital, CMU, China (TREC2020-25); Beijing Friendship Hospital, Capital Medical University, China (2020-P1-药019-01); Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, China (药物临床试验20200721-4); Guangdong Provincial People’s Hospital, China (YW2020-050-02); Shanghai Skin Disease Hospital, China (SSDH-IEC-SG-029-3.1); The First Affiliated Hospital of Fujian Medical University, China (LY2020-012-01); Henan Provincial People’s Hospital, China (AF/SC-08/04.0); The First Affiliated Hospital of Chongqing Medical University, China (CY20203503); Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, China (LLSY2020-06); Chongqing Traditional Chinese Medicine Hospital, China (SHR0302-1); Dermatology Hospital of Southern Medical University, China (2020007); Sinclair Dermatology, Skin Health Institute, Novatrials, Veracity Clinical Research, St George Dermatology and Skin Cancer Clinic, Australia (2019-11-982); Quest Dermatology Research, Dermatologists of Southwest Ohio, Progressive Clinical Research, Skin Search of Rochester, Inc., Skin Wellness Center, Dawes Fretzin Clinical Research, Moore Clinical Research, USA (20201053). |
Vol 89 - N° 5
P. 911-919 - novembre 2023 Retour au numéro
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