Clofazimine-ethambutol-macrolide regimen non-inferior to standard therapy for treating MAC-PD

An original article published in CHEST journal concluded that using clofazimine-ethambutol-macrolide regimen yielded outcomes comparable to those of the standard rifampicin-ethambutol-macrolide treatment in managing MAC-PD (Mycobacterium avium complex pulmonary disease. Although the frequency of adverse reactions was similar between the two regimens, their nature varied. It is essential to consider individual patient characteristics and potential drug-drug interactions when selecting an antibiotic regimen for MAC-PD.

In this clinical trial, adult patients with MAC-PD were randomly assigned ( 1:1) to receive either rifampicin or clofazimine as adjuncts to an ethambutol-macrolide treatment regimen. The primary outcome was successful sputum culture conversion after six months of therapy.

Key findings of this study are:

• Of 40 patients,19 received rifampicin, and 21 received clofazimine next to ethambutol and a macrolide.
• After six months of treatment, both arms showed similar percentages of sputum culture conversion based on intention-to-treat analysis: 58% and 62 % for rifampicin and clofazimine, respectively.
• Study discontinuation due to adverse events was equal in both arms, at 26% vs 33 %. On treatment analysis after six months, sputum culture conversion was 79% in both groups.
• Diarrhoea was more prevalent in the clofazimine arm (76% vs 37%)
• In the rifampicin arm, Arthralgia was more frequent (37% vs 5%).
• No significant difference in QTc prolongation frequency was observed between the two groups.

A clofazimine-ethambutol-macrolide regimen showed similar results to the standard rifampicin-ethambutol-macrolide regimen in treating MAC-PD. The frequency of adverse events was similar, but their nature differed. Consider individual patient characteristics and possible drug-drug interactions when choosing an antibiotic regimen for MAC-PD, they wrote.

Reference:

Zweijpfenning, et al. Clofazimine is a safe and effective alternative for rifampicin in Mycobacterium avium complex pulmonary disease treatment – outcomes of a randomized trial. Chest. https://doi.org/10.1016/j.chest.2023.11.038