Treatment Outcomes of Clofazimine-Containing Regimens in Mycobacterium avium Complex Pulmonary Disease: a retrospective study from two European reference centers

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Abstract

Background: Mycobacterium avium complex (MAC) is the major cause of nontuberculous mycobacterial pulmonary disease (NTM-PD) and clofazimine is increasingly used as an adjunctive therapy. We evaluated outcomes and tolerability of clofazimine-containing regimens in MAC-PD across two European centers. Methods : Retrospective observational study of MAC-PD treated from 2020–2024 in Milan (Italy) and Nijmegen (Netherlands). Diagnosis followed ATS/ERS/ESCMID/IDSA and BTS criteria. Clinical, radiological and microbiological data were collected. Outcomes included treatment completion, mortality and adverse drug events (ADEs). Results: A total of 90 cases were included (74% female, median age 68 years). Disease patterns differed by center, with nodular-bronchiectatic forms prevailing in Milan and fibrocavitary disease in Nijmegen. Clofazimine discontinuation due to ADEs occurred in 14%. Overall, 74% completed therapy and mortality was 8%. Conclusion : Clofazimine-containing regimens showed acceptable safety and favorable outcomes in diverse European MAC-PD populations, supporting its role as a valuable adjunct in MAC-PD management.

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