Socio-demographic and clinical characteristics.
<div><p>Background</p><p>Leprosy remains endemic in many regions despite the global rollout of multidrug therapy (MDT). Clinical cure—defined by completion of a time-based MDT regimen—may not reflect proper bacteriological clearance, particularly in patients with persistent r...
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| _version_ | 1849927627410767872 |
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| author | Andrea Maia Fernandes de Araújo Fonseca (10333122) |
| author2 | Patrícia Sammarco Rosa (10333125) Andrea de Faria Fernandes Belone (22683541) Cleverson Teixeira Soares (16652880) Daniele de Faria Ferreira Bertoluci (22683544) Suzana Madeira Diório (5672051) Luciana Raquel Vincenzi Fachin (6194669) Rodrigo Feliciano do Carmo (12971144) Francisco Bezerra de Almeida Neto (22683547) |
| author2_role | author author author author author author author author |
| author_facet | Andrea Maia Fernandes de Araújo Fonseca (10333122) Patrícia Sammarco Rosa (10333125) Andrea de Faria Fernandes Belone (22683541) Cleverson Teixeira Soares (16652880) Daniele de Faria Ferreira Bertoluci (22683544) Suzana Madeira Diório (5672051) Luciana Raquel Vincenzi Fachin (6194669) Rodrigo Feliciano do Carmo (12971144) Francisco Bezerra de Almeida Neto (22683547) |
| author_role | author |
| dc.creator.none.fl_str_mv | Andrea Maia Fernandes de Araújo Fonseca (10333122) Patrícia Sammarco Rosa (10333125) Andrea de Faria Fernandes Belone (22683541) Cleverson Teixeira Soares (16652880) Daniele de Faria Ferreira Bertoluci (22683544) Suzana Madeira Diório (5672051) Luciana Raquel Vincenzi Fachin (6194669) Rodrigo Feliciano do Carmo (12971144) Francisco Bezerra de Almeida Neto (22683547) |
| dc.date.none.fl_str_mv | 2025-11-25T18:36:03Z |
| dc.identifier.none.fl_str_mv | 10.1371/journal.pntd.0013616.t002 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/dataset/Socio-demographic_and_clinical_characteristics_/30714484 |
| dc.rights.none.fl_str_mv | CC BY 4.0 info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Biochemistry Medicine Microbiology Cell Biology Neuroscience Pharmacology Biotechnology Cancer Infectious Diseases Virology Environmental Sciences not elsewhere classified retrospective case series recommend integrating post many regions despite simplified neurological assessment neurological impairment increased neurological complaints — 74 ), qpcr 123 ), slit known resistance mutations identify therapeutic failure therapeutic failure resistance mutations 101 ), neurological symptoms neurological function 123 specimens treatment histopathological skin smear sequencing (< qpcr detected prevent long persistent reactions november 2023 multidrug therapy morphological indices leprae </ january 2016 gyra </ guide retreatment global rollout extended 24 disease activity confirm cure bacillary persistence assessed using 94 %) 88 ). 44 %) 41 %), 08 %). 05 %). 02 %) 00 %) |
| dc.title.none.fl_str_mv | Socio-demographic and clinical characteristics. |
| dc.type.none.fl_str_mv | Dataset info:eu-repo/semantics/publishedVersion dataset |
| description | <div><p>Background</p><p>Leprosy remains endemic in many regions despite the global rollout of multidrug therapy (MDT). Clinical cure—defined by completion of a time-based MDT regimen—may not reflect proper bacteriological clearance, particularly in patients with persistent reactions or neurological symptoms. We aimed to assess subclinical disease activity in multibacillary patients who completed an extended 24-dose MDT course.</p><p>Methods</p><p>In this retrospective case series, between January 2016 and November 2023, 131 multibacillary patients treated at the Petrolina Infectious Diseases Service (SEINPE) underwent skin biopsy upon completing 24 monthly MDT doses. Disease activity was evaluated by histopathology (H&E and Fite–Faraco staining; n = 123), slit-skin smear with bacilloscopic and morphological indices (BI, n = 126; MI, n = 74), qPCR for <i>M. leprae</i> (n = 101), and nude mice footpad inoculation (n = 45) at Instituto Lauro de Souza Lima, Bauru, Brazil. Drug-resistance mutations were detected by sequencing (<i>folP1, rpoB, gyrA</i>; n = 88). Neurological function was assessed using a Simplified Neurological Assessment (n = 117).</p><p>Results</p><p>Histopathology revealed active disease or bacillary persistence in 62/123 specimens (50.41%), while 29/45 inoculations (64.44%) yielded viable bacilli. qPCR detected <i>M. leprae</i> DNA in 96/101 patients (95.05%). Known resistance mutations were identified in 2/88 patients (2.27%). Clinically, 89/131 patients (67.94%) no longer exhibited skin lesions post-MDT; however, neurological impairment increased from 70/131 (53.44%) at diagnosis to 114/131 (87.02%) at discharge. The proportion with grade 2 disability increased from 5/100 (5.00%) to 27/117 (23.08%). Exact 95% CIs are reported in the manuscript.</p><p>Conclusions</p><p>More than half of patients treated with an extended 24-dose MDT regimen harbored persistent <i>M. leprae</i> activity despite apparent dermatological cure, and most experienced worsening neural function. Time-based discharge criteria alone are inadequate to confirm cure. We recommend integrating post-treatment histopathological, molecular, and inoculation assessments—particularly in patients with persistent reactions or neurological complaints—to identify therapeutic failure, guide retreatment, and prevent long-term disability.</p></div> |
| eu_rights_str_mv | openAccess |
| id | Manara_a24aa6b1cf49db522a652b8a8cd3c2b2 |
| identifier_str_mv | 10.1371/journal.pntd.0013616.t002 |
| network_acronym_str | Manara |
| network_name_str | ManaraRepo |
| oai_identifier_str | oai:figshare.com:article/30714484 |
| publishDate | 2025 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | Socio-demographic and clinical characteristics.Andrea Maia Fernandes de Araújo Fonseca (10333122)Patrícia Sammarco Rosa (10333125)Andrea de Faria Fernandes Belone (22683541)Cleverson Teixeira Soares (16652880)Daniele de Faria Ferreira Bertoluci (22683544)Suzana Madeira Diório (5672051)Luciana Raquel Vincenzi Fachin (6194669)Rodrigo Feliciano do Carmo (12971144)Francisco Bezerra de Almeida Neto (22683547)BiochemistryMedicineMicrobiologyCell BiologyNeurosciencePharmacologyBiotechnologyCancerInfectious DiseasesVirologyEnvironmental Sciences not elsewhere classifiedretrospective case seriesrecommend integrating postmany regions despitesimplified neurological assessmentneurological impairment increasedneurological complaints —74 ), qpcr123 ), slitknown resistance mutationsidentify therapeutic failuretherapeutic failureresistance mutations101 ),neurological symptomsneurological function123 specimenstreatment histopathologicalskin smearsequencing (<qpcr detectedprevent longpersistent reactionsnovember 2023multidrug therapymorphological indicesleprae </january 2016gyra </guide retreatmentglobal rolloutextended 24disease activityconfirm curebacillary persistenceassessed using94 %)88 ).44 %)41 %),08 %).05 %).02 %)00 %)<div><p>Background</p><p>Leprosy remains endemic in many regions despite the global rollout of multidrug therapy (MDT). Clinical cure—defined by completion of a time-based MDT regimen—may not reflect proper bacteriological clearance, particularly in patients with persistent reactions or neurological symptoms. We aimed to assess subclinical disease activity in multibacillary patients who completed an extended 24-dose MDT course.</p><p>Methods</p><p>In this retrospective case series, between January 2016 and November 2023, 131 multibacillary patients treated at the Petrolina Infectious Diseases Service (SEINPE) underwent skin biopsy upon completing 24 monthly MDT doses. Disease activity was evaluated by histopathology (H&E and Fite–Faraco staining; n = 123), slit-skin smear with bacilloscopic and morphological indices (BI, n = 126; MI, n = 74), qPCR for <i>M. leprae</i> (n = 101), and nude mice footpad inoculation (n = 45) at Instituto Lauro de Souza Lima, Bauru, Brazil. Drug-resistance mutations were detected by sequencing (<i>folP1, rpoB, gyrA</i>; n = 88). Neurological function was assessed using a Simplified Neurological Assessment (n = 117).</p><p>Results</p><p>Histopathology revealed active disease or bacillary persistence in 62/123 specimens (50.41%), while 29/45 inoculations (64.44%) yielded viable bacilli. qPCR detected <i>M. leprae</i> DNA in 96/101 patients (95.05%). Known resistance mutations were identified in 2/88 patients (2.27%). Clinically, 89/131 patients (67.94%) no longer exhibited skin lesions post-MDT; however, neurological impairment increased from 70/131 (53.44%) at diagnosis to 114/131 (87.02%) at discharge. The proportion with grade 2 disability increased from 5/100 (5.00%) to 27/117 (23.08%). Exact 95% CIs are reported in the manuscript.</p><p>Conclusions</p><p>More than half of patients treated with an extended 24-dose MDT regimen harbored persistent <i>M. leprae</i> activity despite apparent dermatological cure, and most experienced worsening neural function. Time-based discharge criteria alone are inadequate to confirm cure. We recommend integrating post-treatment histopathological, molecular, and inoculation assessments—particularly in patients with persistent reactions or neurological complaints—to identify therapeutic failure, guide retreatment, and prevent long-term disability.</p></div>2025-11-25T18:36:03ZDatasetinfo:eu-repo/semantics/publishedVersiondataset10.1371/journal.pntd.0013616.t002https://figshare.com/articles/dataset/Socio-demographic_and_clinical_characteristics_/30714484CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/307144842025-11-25T18:36:03Z |
| spellingShingle | Socio-demographic and clinical characteristics. Andrea Maia Fernandes de Araújo Fonseca (10333122) Biochemistry Medicine Microbiology Cell Biology Neuroscience Pharmacology Biotechnology Cancer Infectious Diseases Virology Environmental Sciences not elsewhere classified retrospective case series recommend integrating post many regions despite simplified neurological assessment neurological impairment increased neurological complaints — 74 ), qpcr 123 ), slit known resistance mutations identify therapeutic failure therapeutic failure resistance mutations 101 ), neurological symptoms neurological function 123 specimens treatment histopathological skin smear sequencing (< qpcr detected prevent long persistent reactions november 2023 multidrug therapy morphological indices leprae </ january 2016 gyra </ guide retreatment global rollout extended 24 disease activity confirm cure bacillary persistence assessed using 94 %) 88 ). 44 %) 41 %), 08 %). 05 %). 02 %) 00 %) |
| status_str | publishedVersion |
| title | Socio-demographic and clinical characteristics. |
| title_full | Socio-demographic and clinical characteristics. |
| title_fullStr | Socio-demographic and clinical characteristics. |
| title_full_unstemmed | Socio-demographic and clinical characteristics. |
| title_short | Socio-demographic and clinical characteristics. |
| title_sort | Socio-demographic and clinical characteristics. |
| topic | Biochemistry Medicine Microbiology Cell Biology Neuroscience Pharmacology Biotechnology Cancer Infectious Diseases Virology Environmental Sciences not elsewhere classified retrospective case series recommend integrating post many regions despite simplified neurological assessment neurological impairment increased neurological complaints — 74 ), qpcr 123 ), slit known resistance mutations identify therapeutic failure therapeutic failure resistance mutations 101 ), neurological symptoms neurological function 123 specimens treatment histopathological skin smear sequencing (< qpcr detected prevent long persistent reactions november 2023 multidrug therapy morphological indices leprae </ january 2016 gyra </ guide retreatment global rollout extended 24 disease activity confirm cure bacillary persistence assessed using 94 %) 88 ). 44 %) 41 %), 08 %). 05 %). 02 %) 00 %) |