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Introduction <p>Alopecia areata (AA) is an autoimmune disease characterized by nonscarring hair loss. Ritlecitinib, an oral JAK3/TEC family kinase inhibitor, inhibits cytokines that may be involved in humoral and cellular immunity and is approved to treat severe AA in patients aged ≥ 12&#xa0;years. This sub-study of a phase&#xa0;3 study evaluated primary immune responses to the meningococcal groups A, C, Y, and W-135 oligosaccharide diphtheria CRM<sub>197</sub> conjugate (MenACWY-CRM) vaccine and secondary immune responses to tetanus toxoid booster (Tdap) in patients with AA receiving ritlecitinib.</p> Methods <p>Adult participants in the ALLEGRO-LT study (NCT04006457) receiving open-label ritlecitinib 50-mg once-daily for ≥ 6&#xa0;months were eligible. Participants received a single-dose of 0.5-mL Tdap booster alone or in combination with a single dose of 0.5-mL MenACWY-CRM vaccine. Blood samples were collected at baseline pre-vaccination and 1&#xa0;month post-vaccination.</p> Results <p>Overall, 17 participants received Tdap vaccination, of whom 13 also received meningococcal vaccination. At month&#xa0;1 post-vaccination, 62.5% (10/16) of participants exhibited a tetanus booster response. All participants (16/16) achieved anti-tetanus antibody levels of 1.0&#xa0;IU/mL and 0.1&#xa0;IU/mL; 50% (8/16) showed a &gt; fourfold increase from baseline. For the MenACWY-CRM vaccine, 20% (1/5) and 40% (2/5) of participants achieved human serum bactericidal activity titer for serogroup&#xa0;C ≥ 1:8 and ≥ 1:4, respectively. The geometric mean titer of antibodies for serogroup&#xa0;C increased from baseline (<i>n</i> = 12) to month&#xa0;1 (<i>n</i> = 11). In total, three adverse events (AEs) occurred in three participants. No vaccine-related AEs, serious AEs, or permanent discontinuations due to AEs were reported.</p> Conclusions <p>Primary and secondary immune responses to the meningococcal and tetanus vaccines were observed in patients with AA during chronic ritlecitinib therapy, although the study was limited by the small sample size. The vaccines were well tolerated, no vaccine-related AEs were reported, and there was no exacerbation of underlying disease.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT04006457.</p>

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Responses to Tetanus and Meningococcal Vaccines in Patients with Alopecia Areata Treated with Ritlecitinib

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月24日

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  • Rahmat Ishowo-Adejumo,
  • Agnieszka Zareba,
  • Dalia Wajsbrot,
  • Robert Wolk

摘要

Introduction

Alopecia areata (AA) is an autoimmune disease characterized by nonscarring hair loss. Ritlecitinib, an oral JAK3/TEC family kinase inhibitor, inhibits cytokines that may be involved in humoral and cellular immunity and is approved to treat severe AA in patients aged ≥ 12 years. This sub-study of a phase 3 study evaluated primary immune responses to the meningococcal groups A, C, Y, and W-135 oligosaccharide diphtheria CRM197 conjugate (MenACWY-CRM) vaccine and secondary immune responses to tetanus toxoid booster (Tdap) in patients with AA receiving ritlecitinib.

Methods

Adult participants in the ALLEGRO-LT study (NCT04006457) receiving open-label ritlecitinib 50-mg once-daily for ≥ 6 months were eligible. Participants received a single-dose of 0.5-mL Tdap booster alone or in combination with a single dose of 0.5-mL MenACWY-CRM vaccine. Blood samples were collected at baseline pre-vaccination and 1 month post-vaccination.

Results

Overall, 17 participants received Tdap vaccination, of whom 13 also received meningococcal vaccination. At month 1 post-vaccination, 62.5% (10/16) of participants exhibited a tetanus booster response. All participants (16/16) achieved anti-tetanus antibody levels of 1.0 IU/mL and 0.1 IU/mL; 50% (8/16) showed a > fourfold increase from baseline. For the MenACWY-CRM vaccine, 20% (1/5) and 40% (2/5) of participants achieved human serum bactericidal activity titer for serogroup C ≥ 1:8 and ≥ 1:4, respectively. The geometric mean titer of antibodies for serogroup C increased from baseline (n = 12) to month 1 (n = 11). In total, three adverse events (AEs) occurred in three participants. No vaccine-related AEs, serious AEs, or permanent discontinuations due to AEs were reported.

Conclusions

Primary and secondary immune responses to the meningococcal and tetanus vaccines were observed in patients with AA during chronic ritlecitinib therapy, although the study was limited by the small sample size. The vaccines were well tolerated, no vaccine-related AEs were reported, and there was no exacerbation of underlying disease.

Trial Registration

ClinicalTrials.gov identifier, NCT04006457.