Evidence map›Paper›PMID 28222139›Full record

ArticlePLoS neglected tropical diseases2017

Leprosy reactions: The predictive value of Mycobacterium leprae-specific serology evaluated in a Brazilian cohort of leprosy patients (U-MDT/CT-BR).

Emerith Mayra Hungria, Samira Bührer-Sékula, Regiane Morillas de Oliveira, Lúcio Cartaxo Aderaldo, Araci de Andrade Pontes, Rossilene Cruz, Heitor de Sá Gonçalves, Maria Lúcia Fernandes Penna, Gerson Oliveira Penna, Mariane Martins de Araújo Stefani

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in PLoS neglected tropical diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00669643 (Independent Study to Establish the Efficacy of the Six Doses Uniform MDT Regimen), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00669643 phase4completednot on this map

Independent Study to Establish the Efficacy of the Six Doses Uniform MDT Regimen (U-MDT) for Leprosy Patients

TypeinterventionalSponsorUniversity of BrasiliaRan2007 to 2016Enrolled859ConditionsLeprosyArmsPB 6 doses - Rifampicin and Dapsone, PB 6 doses - Rifampicin, Clofazimine and Dapsone, MB 12 doses - Rifampicin, Clofazimine and Dapsone, MB 6 doses - Rifampicin, Clofazimine and Dapsone
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 41 citations in OpenAlex.

  1. Observational
  2. Article
  3. Article
  4. Article
  5. Challenges and advances in serological and molecular tests to aid leprosy diagnosis.Experimental biology and medicine (Maywood, N.J.) · 2023
    Review
  6. Qua vadis leprosy?The Indian journal of medical research · 2023
    Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Leprosy surveillance study in a highly endemic Brazilian area using leprosy specific serologic tests and IFNγ whole blood assay.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Frontiers in immunology · 2018
    Article
  17. A Study of NLRC4 in Patients with Leprosy.Indian journal of dermatology
    Article
  18. Review
  19. Drug Resistance inIndian dermatology online journal
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 2 countries.

Emerith Mayra HungriaInstituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, GO, Brasil.
Samira Bührer-SékulaInstituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, GO, Brasil.ORCID 0000-0002-5984-7770
Regiane Morillas de OliveiraInstituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, GO, Brasil.
Lúcio Cartaxo AderaldoCentro de Dermatologia Dona Libânia, Fortaleza, Ceará, Brasil.
Araci de Andrade PontesCentro de Dermatologia Dona Libânia, Fortaleza, Ceará, Brasil.
Rossilene CruzFundação de Dermatologia Tropical e Venereologia Alfredo da Matta, Manaus, Amazonas, Brasil.
Heitor de Sá GonçalvesCentro de Dermatologia Dona Libânia, Fortaleza, Ceará, Brasil.
Maria Lúcia Fernandes PennaDepartamento de Epidemiologia e Bioestatística, Universidade Federal Fluminense, Rio de Janeiro, Rio de Janeiro, Brasil.
Gerson Oliveira PennaNúcleo de Medicina Tropical, Universidade de Brasília, Brasília, DF, Brasil.
Mariane Martins de Araújo StefaniInstituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, GO, Brasil.
Universidade Federal de Goiás · BRInstituto de Dermatologia Dona Libania · BRFundação de Medicina Tropical · BRUniversidade de Brasília · BRUniversidade Federal Fluminense · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeprosy reactions, reversal reactions/RR and erythema nodosum leprosum/ENL, can cause irreversible nerve damage, handicaps and deformities. The study of Mycobacterium leprae-specific serologic responses at diagnosis in the cohort of patients enrolled at the Clinical Trial for Uniform Multidrug Therapy Regimen for Leprosy Patients in Brazil/U-MDT/CT-BR is suitable to evaluate its prognostic value for the development of reactions. METHODOLOGY: IgM and IgG antibody responses to PGL-I, LID-1, ND-O-LID were evaluated by ELISA in 452 reaction-free leprosy patients at diagnosis, enrolled and monitored for the development of leprosy reactions during a total person-time of 780,930 person-days, i.e. 2139.5 person-years, with a maximum of 6.66 years follow-up time. PRINCIPAL

findingsAmong these patients, 36% (160/452) developed reactions during follow-up: 26% (119/452) RR and 10% (41/452) had ENL. At baseline higher anti-PGL-I, anti-LID-1 and anti-ND-O-LID seropositivity rates were seen in patients who developed ENL and RR compared to reaction-free patients (p<0.0001). Seroreactivity in reactional and reaction-free patients was stratified by bacilloscopic index/BI categories. Among BI negative patients, higher anti-PGL-I levels were seen in RR compared to reaction-free patients (p = 0.014). In patients with 0<BI<3, (36 RR, 36 reaction-free), higher antibody levels to PGL-I (p = 0.014) and to LID-1 (p = 0.035) were seen in RR while difference in anti-ND-O-LID positivity was borderline (p = 0.052). Patients with BI≥3 that developed ENL had higher levels of anti-LID-1 antibodies (p = 0.028) compared to reaction-free patients. Anti-PGL-I serology had a limited predictive value for RR according to receiver operating curve/ROC analyses (area-under-the-curve/AUC = 0.7). Anti LID-1 serology at baseline showed the best performance to predict ENL (AUC 0.85).

conclusionsOverall, detection of anti-PGL-I, anti-LID-1 and anti-ND-O-LID antibodies at diagnosis, showed low sensitivity and specificity for RR prediction, indicating low applicability of serological tests for RR prognosis. On the other hand, anti-LID-1 serology at diagnosis has shown prognostic value for ENL development in BI positive patients.

trial registrationClinicalTrials.gov NCT00669643.

Indexed as

AdultAntibodies, BacterialBrazilEnzyme-Linked Immunosorbent AssayFemaleHumansImmunoglobulin GImmunoglobulin MLeprosyMaleMycobacterium lepraePredictive Value of TestsPrognosisSensitivity and SpecificitySerologic TestsAntibodies, BacterialImmunoglobulin GImmunoglobulin M

Identifiers

PMID28222139
PMCPMC5336302
OpenAlexW2590230045

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.