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Войти в исследования Schizophrenia bulletin · 2026
Clozapine-Associated Neutropenia among People on Clozapine in Japan: A Nationally Representative Retrospective Cohort Study.
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Trott Mike, Northwood Korinne, Hata Takeo, Nishida Keiichiro, Siskind Dan, Kanazawa Tetsufumi
Аннотация
BACKGROUND AND HYPOTHESIS: Clozapine is the most effective antipsychotic for treatment-resistant schizophrenia, but use is constrained by potentially life-threatening neutropenia and mandatory hematological monitoring. Evidence from Western cohorts suggests risk is concentrated early in treatment, yet data from Japan where monitoring is stringent, remain limited.
STUDY DESIGN: Retrospective study including all patients prescribed clozapine from July 2009-January 2020 in Japan. Mild neutropenia was defined as absolute neutrophil count (ANC) 1.0-1.5 × 109/L, and serious neutropenia as ANC <1.0 × 109/L. Cumulative incidence of first mild and serious neutropenia was estimated using competing-risks methods. Associations with serious neutropenia were examined using Fine-Gray regression, including 2-week titration rate.
STUDY RESULTS: The cohort comprised 8263 individuals contributing 764 180 blood tests, with a median follow-up of 102 weeks. Overall, 3.0% patients experienced mild neutropenia and 2.2% had serious neutropenia. Among clozapine-naïve patients, cumulative incidence was 1.8% for mild and 1.6% for serious neutropenia at 18 weeks, rising to 3.1% and 2.5% at 104 weeks, respectively. Faster clozapine titration rate was associated with higher incidence of serious neutropenia (sub-distribution hazard ratio [sHR] 1.22, 95% CI, 1.02-1.45 per 50 mg dosage increase at 2-weeks), as was older age (sHR 1.05, 95% CI, 1.04-1.06), while prior clozapine exposure was associated with lower incidence (sHR 0.27, 95% CI, 0.09-0.86).
CONCLUSIONS: In Japan, neutropenia among clozapine-treated patients accrued predominantly within the first 1-2 years, with faster titration in the first 2-weeks being associated with a 22% increase in serious neutropenia risk per 50 mg. These findings support risk-stratified, less intensive monitoring approaches beyond the first 2 years.
STUDY DESIGN: Retrospective study including all patients prescribed clozapine from July 2009-January 2020 in Japan. Mild neutropenia was defined as absolute neutrophil count (ANC) 1.0-1.5 × 109/L, and serious neutropenia as ANC <1.0 × 109/L. Cumulative incidence of first mild and serious neutropenia was estimated using competing-risks methods. Associations with serious neutropenia were examined using Fine-Gray regression, including 2-week titration rate.
STUDY RESULTS: The cohort comprised 8263 individuals contributing 764 180 blood tests, with a median follow-up of 102 weeks. Overall, 3.0% patients experienced mild neutropenia and 2.2% had serious neutropenia. Among clozapine-naïve patients, cumulative incidence was 1.8% for mild and 1.6% for serious neutropenia at 18 weeks, rising to 3.1% and 2.5% at 104 weeks, respectively. Faster clozapine titration rate was associated with higher incidence of serious neutropenia (sub-distribution hazard ratio [sHR] 1.22, 95% CI, 1.02-1.45 per 50 mg dosage increase at 2-weeks), as was older age (sHR 1.05, 95% CI, 1.04-1.06), while prior clozapine exposure was associated with lower incidence (sHR 0.27, 95% CI, 0.09-0.86).
CONCLUSIONS: In Japan, neutropenia among clozapine-treated patients accrued predominantly within the first 1-2 years, with faster titration in the first 2-weeks being associated with a 22% increase in serious neutropenia risk per 50 mg. These findings support risk-stratified, less intensive monitoring approaches beyond the first 2 years.