RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery
Background: World Health Organization (WHO) has recommended Multidrug Therapy (MDT/WHO) for Hansen’s Disease (HD) since 1982; nevertheless, relapse, antimicrobial resistance, and adverse reactions indicate the need for new therapeutic regimens. We evaluated the efficacy and safety of the new anti-HD...
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Elsevier
2025-07-01
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| Series: | Brazilian Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S141386702500042X |
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| author | Marco Andrey Cipriani Frade Gustavo Sartori Albertino Filipe Rocha Lima Natália Aparecida de Paula Fabiana Aparecida Correa Cinto Fernanda Cruz Perecin Andrezza Westin Wilson Marques Junior Helena Barbosa Lugão |
| author_facet | Marco Andrey Cipriani Frade Gustavo Sartori Albertino Filipe Rocha Lima Natália Aparecida de Paula Fabiana Aparecida Correa Cinto Fernanda Cruz Perecin Andrezza Westin Wilson Marques Junior Helena Barbosa Lugão |
| author_sort | Marco Andrey Cipriani Frade |
| collection | DOAJ |
| description | Background: World Health Organization (WHO) has recommended Multidrug Therapy (MDT/WHO) for Hansen’s Disease (HD) since 1982; nevertheless, relapse, antimicrobial resistance, and adverse reactions indicate the need for new therapeutic regimens. We evaluated the efficacy and safety of the new anti-HD regimen RIMOXCLAMIN (Rifampicin, Moxifloxacin, Clarithromycin, and Minocycline) compared with standard Multidrug Therapy provided by WHO (MDT/WHO). Methodology/principal findings: 66 multibacillary HD new cases (46: RIMOXCLAMIN / 20: MDT/WHO) were evaluated between 2015 and 2023. Patients were followed up at least bimonthly by hansenologists for neurological and cutaneous findings and side effects of treatments. Hands/feet tactile sensitivity tests by Semmes Weinstein Monofilaments (SWM) and Physical Disability Grade (PDG) were carried out on the diagnosis, 3rd, 6th, and 12th months. 84.8 % and 80 % of the patients were classified as Borderline-Borderline (BB) in RIMOXCLAMIN and MDT/WHO groups, respectively, with no significant difference between them (p = 0.12). Nerve thickening was reduced by palpation in both groups: in RIMOXCLAMIN, reduction occurred early (65 % to 28 % at 6-months, p = 0.03; 9 % at 12-months, p = 0.03), while in MDT/WHO, it was later (95 % to 40 % at 12-months, p = 0.002). The greatest difference was at 6 months (p < 0.0001). A significant reduction was observed in pain scales on the 3rd month of treatment only with RIMOXCLAMIN; in the end, both groups showed significant reductions in pain scales, being greater in RIMOXCLAMIN group. 0.5 % reduction in the number of abnormal SWM points on the hands compared to baseline, while in the MDT/WHO group, there was an increase of abnormal points of 5.4 %. On the feet, RIMOXCLAMIN showed a reduction of 17.9 %, while in the MDT/WHO, it was 10.3 %. During follow-up, the RIMOXCLAMIN showed a significant decrease in the sum of altered SWM points compared to MDT/WHO (p < 0.05). Only RIMOXCLAMIN improved PDG monitoring. Both groups reported mild adverse effects. Conclusions/significance: The results indicate that RIMOXCLAMIN was superior to MDT/WHO in terms of quick recovery of neurological damage, evidenced by the improvement of symptoms and sensitivity in hands and feet as early as the third month, with a progressive improvement, maintained after the end of treatment, including a reduce of patients with PDG. |
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| institution | DOAJ |
| issn | 1413-8670 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Elsevier |
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| series | Brazilian Journal of Infectious Diseases |
| spelling | doaj-art-0d759ef4eca642cda8b6c00ce0404e8c2025-08-20T02:42:34ZengElsevierBrazilian Journal of Infectious Diseases1413-86702025-07-0129410453910.1016/j.bjid.2025.104539RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recoveryMarco Andrey Cipriani Frade0Gustavo Sartori Albertino1Filipe Rocha Lima2Natália Aparecida de Paula3Fabiana Aparecida Correa Cinto4Fernanda Cruz Perecin5Andrezza Westin6Wilson Marques Junior7Helena Barbosa Lugão8Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Divisão de Dermatologia, Departamento de Medicina Interna, São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, Brazil; Corresponding author.Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Divisão de Dermatologia, Departamento de Medicina Interna, São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, BrazilUniversidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Departamento de Bioquímica e Imunologia, São Paulo, SP, BrazilUniversidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Divisão de Dermatologia, Departamento de Medicina Interna, São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, BrazilUniversidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Divisão de Assistência Farmacêutica, Unidade Especializada de Tratamento de Doenças Infeciosas (UETDI), São Paulo, SP, BrazilUniversidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, BrazilUniversidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, BrazilUniversidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Departamento de Neurologia, Divisão de Distúrbios Neuromusculares, Ribeirão Preto, SP, BrazilUniversidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Divisão de Dermatologia, Departamento de Medicina Interna, São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, BrazilBackground: World Health Organization (WHO) has recommended Multidrug Therapy (MDT/WHO) for Hansen’s Disease (HD) since 1982; nevertheless, relapse, antimicrobial resistance, and adverse reactions indicate the need for new therapeutic regimens. We evaluated the efficacy and safety of the new anti-HD regimen RIMOXCLAMIN (Rifampicin, Moxifloxacin, Clarithromycin, and Minocycline) compared with standard Multidrug Therapy provided by WHO (MDT/WHO). Methodology/principal findings: 66 multibacillary HD new cases (46: RIMOXCLAMIN / 20: MDT/WHO) were evaluated between 2015 and 2023. Patients were followed up at least bimonthly by hansenologists for neurological and cutaneous findings and side effects of treatments. Hands/feet tactile sensitivity tests by Semmes Weinstein Monofilaments (SWM) and Physical Disability Grade (PDG) were carried out on the diagnosis, 3rd, 6th, and 12th months. 84.8 % and 80 % of the patients were classified as Borderline-Borderline (BB) in RIMOXCLAMIN and MDT/WHO groups, respectively, with no significant difference between them (p = 0.12). Nerve thickening was reduced by palpation in both groups: in RIMOXCLAMIN, reduction occurred early (65 % to 28 % at 6-months, p = 0.03; 9 % at 12-months, p = 0.03), while in MDT/WHO, it was later (95 % to 40 % at 12-months, p = 0.002). The greatest difference was at 6 months (p < 0.0001). A significant reduction was observed in pain scales on the 3rd month of treatment only with RIMOXCLAMIN; in the end, both groups showed significant reductions in pain scales, being greater in RIMOXCLAMIN group. 0.5 % reduction in the number of abnormal SWM points on the hands compared to baseline, while in the MDT/WHO group, there was an increase of abnormal points of 5.4 %. On the feet, RIMOXCLAMIN showed a reduction of 17.9 %, while in the MDT/WHO, it was 10.3 %. During follow-up, the RIMOXCLAMIN showed a significant decrease in the sum of altered SWM points compared to MDT/WHO (p < 0.05). Only RIMOXCLAMIN improved PDG monitoring. Both groups reported mild adverse effects. Conclusions/significance: The results indicate that RIMOXCLAMIN was superior to MDT/WHO in terms of quick recovery of neurological damage, evidenced by the improvement of symptoms and sensitivity in hands and feet as early as the third month, with a progressive improvement, maintained after the end of treatment, including a reduce of patients with PDG.http://www.sciencedirect.com/science/article/pii/S141386702500042XHansen’s diseaseLeprosyRIMOXCLAMINTreatmentSensitivityMultidrug therapy |
| spellingShingle | Marco Andrey Cipriani Frade Gustavo Sartori Albertino Filipe Rocha Lima Natália Aparecida de Paula Fabiana Aparecida Correa Cinto Fernanda Cruz Perecin Andrezza Westin Wilson Marques Junior Helena Barbosa Lugão RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery Brazilian Journal of Infectious Diseases Hansen’s disease Leprosy RIMOXCLAMIN Treatment Sensitivity Multidrug therapy |
| title | RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery |
| title_full | RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery |
| title_fullStr | RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery |
| title_full_unstemmed | RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery |
| title_short | RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery |
| title_sort | rimoxclamin new therapeutic regimen for hansen s disease cure based on effective sensitivity recovery |
| topic | Hansen’s disease Leprosy RIMOXCLAMIN Treatment Sensitivity Multidrug therapy |
| url | http://www.sciencedirect.com/science/article/pii/S141386702500042X |
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