How Effective is Clofazimine in Treating Multidrug-Resistant Tuberculosis?

Should clofazimine remain a “second-choice agent” for treating patients with multidrug-resistant tuberculosis? A meta-analysis reviews the current evidence.

Using clofazimine in the treatment of drug-resistant tuberculosis (TB) is linked to better outcomes, including treatment completion and cure rates, and to lower treatment failure risk. These findings were published in a meta-analysis in Microbes and Infection.

Researchers state current guidelines conditionally recommend clofazimine — a drug that is used to treat leprosy — as a “second-choice agent” for patients with multidrug-resistant TB. However, given the need for better treatment options for multidrug-resistant TB, several studies have recently evaluated the efficacy, safety, and tolerability of clofazimine for drug-resistant TB. The current review and meta-analysis was undertaken to summarize existing evidence.

Reviewers searched the PubMed, Web of Science, and EMBASE databases for studies published up to July 10, 2021. After screening by reviewers, 8 studies with 3219 patients were selected for the meta-analysis.

Treatment completion rates were higher for patients receiving clofazimine-containing regimens compared with those not receiving the drug (RR 1.185, 95% CI 1.060-1.325, P =.003). Patients in the clofazimine treatment group also showed a significant reduction in treatment failure (RR 0.598, 95% CI 0.473-0.756, P <.001).

Additional subgroup analysis of randomized control trials revealed that the clofazimine group had higher rates of favorable outcomes (RR 1.203, 95% CI 1.029-1.407, P =.020), treatment completion (RR 3.167, 95% CI 2.043-4.908, P <.001), and cure (RR 1.251, 95% CI 1.031-1.518, P =.023). Patients in the clofazimine group had a lower risk of treatment failure (RR 0.529, 95% CI 0.454-0.616, P <.001), but there was no significant effect on all-cause mortality between groups.

A common adverse reaction to clofazimine is skin discoloration; the incidence rate for this was 10.4% to 94.3% among patients included in the meta-analysis.

Study limitations included the small number of studies involving clofazimine and significant heterogeneity between the results of these studies. Moreover, the inclusion of HIV patients in some studies may have contributed to inconsistent all-cause mortality rates, and some studies used other drugs in addition to clofazimine.

 “In general, our findings indicate that the use of clofazimine will benefit patients with [multidrug-resistant] TB/[extensively drug-resistant] TB,” the researchers concluded.


Wang M-G, Liu X-M, Wu S-Q, He J-Q. Impacts of clofazimine on the treatment outcomes of drug-resistant tuberculosis. Microbes Infect. Published online July 2, 2022. doi:10.1016/j.micinf.2022.105020