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Original Research |

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

Stacey L. Martiniano, MD, MCSC; Brandie D. Wagner, PhD; Adrah Levin, MPH; Jerry A. Nick, MD; Scott D. Sagel, MD, PhD; Charles L. Daley, MD.
Author and Funding Information

Conflict of Interest Statements:

Drs. Martiniano, Nick and Sagel receive grants from the Cystic Fibrosis Foundation and National Institutes of Health that fund research involving individuals with cystic fibrosis and mycobacterial infection.

Dr. Wagner and Ms. Levin have no conflicts of interest to disclose.

Dr. Daley received a research grant from Insmed and served on a data monitoring committee for Novartis.

Fundinginformation: This work was supported by the Cystic Fibrosis Foundation (MARTIN14A0, NICK15R0)

1Department of Pediatrics, Children’s Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, USA

2Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, USA

3Division of Mycobacterial and Respiratory Infections, National Jewish Health, Denver, CO, USA

4Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, CO, USA

Corresponding Author: Stacey L. Martiniano, MD, Children’s Hospital Colorado, 13123 E. 16th Ave. B 395 Aurora, CO 80045 Institutions: Children’s Hospital Colorado, University of Colorado, National Jewish Health


Copyright 2017, . All Rights Reserved.


Chest. 2017. doi:10.1016/j.chest.2017.04.175
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Abstract

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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