RIMOXCLAMIN's Therapeutic Impact in a Larger Brazilian Hansen's Disease Population

RIMOXCLAMIN, a new antibiotic regimen for Hansen's disease (HD), combines rifampicin, moxifloxacin, clarithromycin, and minocycline; the WHO-MDT combines rifampicin, dapsone, and clofazimine. To overcome limitations of WHO-MDT, we evaluated both regimens in a 2-arm cohort of multibacillary patients.

Two-arm observational cohort included 162 newly diagnosed multibacillary cases (103 RIMOXCLAMIN and 59 WHO-MDT) evaluated between 2015 and 2025. Patients were assessed at least quarterly (baseline and months 3, 6, and 12) for neurological and cutaneous findings, adverse events, tactile sensitivity, and physical disability grade (PDG).

Neurological symptoms were frequent regardless of lesion count (≤5 vs > 5; P > .05). RIMOXCLAMIN demonstrated a greater reduction in nerve thickening than WHO-MDT (P < .0001) and increased PDG-0 from 18% to 82% (P < .0001), compared with 22%-53% in the WHO-MDT group (P = .0006). RIMOXCLAMIN reduced PDG-2 by 67% at month 6 (P = .002) and 83% at discharge (P < .0001), whereas WHO-MDT showed no change at month 6 and a 50% reduction at discharge. At month 3, neurological symptoms were greater in the RIMOXCLAMIN group than in the WHO-MDT, with no intragroup differences. WHO-MDT showed higher adverse events, including severe anemia (requiring dapsone discontinuation in 33.9% [20/59]). RIMOXCLAMIN adverse events were mild, requiring regimen adjustments in 19.4% (20/103) without additional medications. A general limitation is that the groups are not fully socioeconomically comparable.

RIMOXCLAMIN was safe and clinically advantageous as a first-line HD regimen, offering faster neurological recovery, disability reversal, and minimal adverse event. These findings support incorporating neurological parameters of skin sensory changes, as lesion count alone does not appear to be a reliable marker of the clinical and neurological severity.