This retrospective analysis included 10 patients with relapsed/refractory warm autoimmune hemolytic anemia (wAIHA) who received zanubrutinib (treatment course: 3-6 months) and completed at least 3 months of follow-up at Peking Union Medical College Hospital from July 2022 to January 2024. The cohort included two male and eight female patients with a median age of 63 years (range: 36-76), who had received a median of 9 months (range: 3-22) of previous therapies. At 1-month, 3-month, and final follow-up (median 7 months), the overall response (OR) rates were 30%, 60%, and 60%, with corresponding complete response (CR) rates of 20%, 40%, and 40%, respectively. The median time to achieve a response was 2 months (range: 1-2) among the responders. No disease relapse or clonal progression was documented during follow-up. Treatment-related adverse events occurred in 30% of the patients (all grade 1-2 reversible events). One responder died of infectious multiple organ failure at 8 months after treatment initiation. Our results indicate that zanubrutinib provides rapid amelioration of anemia with manageable short-term safety in patients with relapsed/refractory wAIHA.

This retrospective analysis included 10 patients with relapsed/refractory warm autoimmune hemolytic anemia (wAIHA) who received zanubrutinib (treatment course: 3-6 months) and completed at least 3 months of follow-up at Peking Union Medical College Hospital from July 2022 to January 2024. The cohort included two male and eight female patients with a median age of 63 years (range: 36-76), who had received a median of 9 months (range: 3-22) of previous therapies. At 1-month, 3-month, and final follow-up (median 7 months), the overall response (OR) rates were 30%, 60%, and 60%, with corresponding complete response (CR) rates of 20%, 40%, and 40%, respectively. The median time to achieve a response was 2 months (range: 1-2) among the responders. No disease relapse or clonal progression was documented during follow-up. Treatment-related adverse events occurred in 30% of the patients (all grade 1-2 reversible events). One responder died of infectious multiple organ failure at 8 months after treatment initiation. Our results indicate that zanubrutinib provides rapid amelioration of anemia with manageable short-term safety in patients with relapsed/refractory wAIHA.