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Background <p>We report pooled safety data for baricitinib treatment of severe alopecia areata in patients in BRAVE-AA1 (phase II/III) and BRAVE-AA2 (phase III), including data from the long-term extension and bridging extension periods.</p> Methods <p>Data are reported from the extended dataset (patients receiving continuous baricitinib 2 mg or 4 mg) and the all-baricitinib dataset (all patients receiving any dose of baricitinib at any time during the trials). Safety outcomes include treatment-emergent adverse events, adverse events of special interest, and abnormal changes in laboratory test results. Incidence rates (IRs) per 100 patient-years were calculated based on time at risk. Data cutoff dates were 22 May, 2023, for BRAVE-AA1 and 8 May, 2023, for BRAVE-AA2 and included follow-up through at least 152 weeks.</p> Results <p>Data were collected for 1303 patients treated with baricitinib, reflecting 2789.7 patient-years of exposure (median, 825 days; maximum, 1460 days). Most treatment-emergent adverse events were mild to moderate in severity. Incidence rates of serious adverse events (IR = 2.6) and treatment discontinuations because of adverse events (IR = 1.7) were generally low and remained similar to data presented through at least 104 weeks of follow-up. In an additional 1 year of follow-up, no new cases of serious infections, opportunistic infections, major adverse cardiovascular events, deep vein thromboses, or pulmonary embolisms were observed. The IRs for non-melanoma skin cancer (IR = 0.1) and other malignancies (IR = 0.2) remained stable over time. The IR of herpes zoster was comparable to previously reported IRs (IR = 1.9). Laboratory changes were generally consistent over time. No deaths were reported in either study.</p> Conclusions <p>Long-term safety data from BRAVE-AA1 and BRAVE-AA2 are consistent with previously reported data from the baricitinib alopecia areata clinical trial program and demonstrate no new safety concerns or signals for baricitinib through a maximum exposure of 4 years.</p> Clinical Trial Registration <p>BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) were registered on 18 June, 2018, and 1 April, 2019, respectively.</p>

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Safety of Baricitinib in Adults with Severe Alopecia Areata from Two Phase III Trials Over a Median of 2.3 Years and Up to 4 Years of Treatment

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月11日

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  • Brett King,
  • Arash Mostaghimi,
  • Yutaka Shimomura,
  • Bianca Maria Piraccini,
  • Ulrike Blume-Peytavi,
  • Angelina Sontag,
  • Yves Dutronc,
  • Karen Denning,
  • Jill Kolodsick,
  • Xiaoyu Lu,
  • Ayush Srivastava,
  • Rodney Sinclair

摘要

Background

We report pooled safety data for baricitinib treatment of severe alopecia areata in patients in BRAVE-AA1 (phase II/III) and BRAVE-AA2 (phase III), including data from the long-term extension and bridging extension periods.

Methods

Data are reported from the extended dataset (patients receiving continuous baricitinib 2 mg or 4 mg) and the all-baricitinib dataset (all patients receiving any dose of baricitinib at any time during the trials). Safety outcomes include treatment-emergent adverse events, adverse events of special interest, and abnormal changes in laboratory test results. Incidence rates (IRs) per 100 patient-years were calculated based on time at risk. Data cutoff dates were 22 May, 2023, for BRAVE-AA1 and 8 May, 2023, for BRAVE-AA2 and included follow-up through at least 152 weeks.

Results

Data were collected for 1303 patients treated with baricitinib, reflecting 2789.7 patient-years of exposure (median, 825 days; maximum, 1460 days). Most treatment-emergent adverse events were mild to moderate in severity. Incidence rates of serious adverse events (IR = 2.6) and treatment discontinuations because of adverse events (IR = 1.7) were generally low and remained similar to data presented through at least 104 weeks of follow-up. In an additional 1 year of follow-up, no new cases of serious infections, opportunistic infections, major adverse cardiovascular events, deep vein thromboses, or pulmonary embolisms were observed. The IRs for non-melanoma skin cancer (IR = 0.1) and other malignancies (IR = 0.2) remained stable over time. The IR of herpes zoster was comparable to previously reported IRs (IR = 1.9). Laboratory changes were generally consistent over time. No deaths were reported in either study.

Conclusions

Long-term safety data from BRAVE-AA1 and BRAVE-AA2 are consistent with previously reported data from the baricitinib alopecia areata clinical trial program and demonstrate no new safety concerns or signals for baricitinib through a maximum exposure of 4 years.

Clinical Trial Registration

BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) were registered on 18 June, 2018, and 1 April, 2019, respectively.