Safety and Effectiveness of Clofazimine for Primary and Refractory Nontuberculous Mycobacterial Infection

Background

Clofazimine is an antimicrobial agent that has activity in vitro against mycobacteria. Increasingly, it has been used for the treatment of nontuberculous mycobacteria (NTM), despite limited data supporting use in this setting. The objective of this study was to evaluate safety, tolerability, and clinical outcomes associated with clofazimine in patients with NTM infection.

Methods

Observational-cohort study of clofazimine used for pediatric and adult cystic fibrosis (CF) and non-CF patients with pulmonary and extrapulmonary NTM infection as part of a multidrug regimen from 2006-2014. Treatment regimens and adverse drug reactions (ADRs) were captured.

Results

One hundred twelve subjects were included (median age 62 years); 24 subjects (21%) had CF. Eighty-seven (78%) had refractory disease with failure of prior therapy. Fifty-four subjects (48%) had M. abscessus complex, 41 (37%) had M. avium complex, and 16 (14%) had two NTM species. The median duration of clofazimine use was 383 days (range 3 – 2,419 days). Sixteen subjects (14%) stopped clofazimine due to an ADR after a median of 101 days (95% CI, 63-119 days). Forty-one of 82 subjects (50%) with pulmonary disease converted to negative NTM cultures within 12 months.

Conclusions

Clofazimine is a safe, reasonably tolerated, and active oral drug for NTM infection in our heterogeneous population of pediatric and adult CF and non-CF patients. It should be considered as an alternative drug for treatment of NTM disease.

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