title: Can baseline ML Flow test results predict leprosy reactions? An investigation in a cohort of patients enrolled in the uniform multidrug therapy clinical trial for leprosy patients in Brazil.
abstract: BACKGROUND
  The predictive value of the serology to detection of IgM against the Mycobacterium leprae-derived phenolic glycolipid-I/PGL-I to identify leprosy patients who are at higher risk of developing reactions remains controversial. Whether baseline results of the ML Flow test can predict leprosy reactions was investigated among a cohort of patients enrolled in The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR).
  
  
  METHODS
  This was a descriptive study focusing on the main clinical manifestations of leprosy patients enrolled in the U-MDT/CT-BR from March 2007 to February 2012 at two Brazilian leprosy reference centers. For research purposes, 753 leprosy patients were categorized according to a modified Ridley-Jopling (R&J) classification and according to the development of leprosy reactions (reversal reaction/RR and erythema nodosum leprosum/ENL), and whether they had a positive or negative bacillary index/BI.
  
  
  RESULTS
  More than half of the patients (55.5 %) reported leprosy reaction: 18.3 % (138/753) had a RR and 5.4 % (41/753) had ENL. Leprosy reactions were more frequent in the first year following diagnosis, as seen in 27 % (205/753) of patients, while 19 % (142/753) developed reactions during subsequent follow-up. Similar frequencies of leprosy reactions and other clinical manifestations were observed in paucibacillary (PB) and multibacillary (MB) leprosy patients treated with U-MDT and regular MDT (R-MDT) (P = 0.43 and P = 0.61, respectively). Compared with PB patients, leprosy reactions were significantly more frequent in MB patients with a high BI, and more patients developed RR than ENL. However, RR and neuritis were also reported in patients with a negative BI. At baseline, the highest rate of ML Flow positivity was observed in patients with a positive BI, especially those who developed ENL, followed by patients who had neuritis and RR. Among reaction-free patients, 81.9 % were ML Flow positive, however, the differences were not statistically significant compared to reactional patients (P = 0.45).
  
  
  CONCLUSIONS
  MB and PB patients treated with R-MDT and U-MDT showed similar frequencies of RR and other clinical manifestations. Positive ML Flow tests were associated with MB leprosy and BI positivity. However, ML Flow test results at baseline showed limited sensitivity and specificity for predicting the development of leprosy reactions.
authors.affiliation: Tropical Pathology and Public Health Institute, Federal University of Goiás, Goiania, Goiás, Brazil.
authors.forename: Emerith Mayra
authors.initials: EM
authors.lastname: Hungria
authors.affiliation: Tropical Pathology and Public Health Institute, Federal University of Goiás, Goiania, Goiás, Brazil.
authors.forename: Regiane Morillas
authors.initials: RM
authors.lastname: Oliveira
authors.affiliation: Tropical Medicine Centre, University of Brasília, Brasília, DF, Brazil.
authors.forename: Gerson Oliveira
authors.initials: GO
authors.lastname: Penna
authors.affiliation: Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil.
authors.forename: Lúcio Cartaxo
authors.initials: LC
authors.lastname: Aderaldo
authors.affiliation: Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil.
authors.forename: Maria Araci de Andrade
authors.initials: MA
authors.lastname: Pontes
authors.affiliation: Tropical Medicine Foundation/Foundation "Alfredo da Matta", Manaus, Amazonas, Brazil.
authors.forename: Rossilene
authors.initials: R
authors.lastname: Cruz
authors.affiliation: Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil.
authors.forename: Heitor de Sá
authors.initials: HS
authors.lastname: Gonçalves
authors.affiliation: Epidemiology and Biostatistics Department, Federal University Fluminense, Niterói, Rio de Janeiro, Brazil.
authors.forename: Maria Lúcia Fernandes
authors.initials: ML
authors.lastname: Penna
authors.affiliation: Department of Community Health, Federal University of Ceará, Fortaleza, Brazil.
authors.forename: Ligia Regina Franco Sansigolo
authors.initials: LR
authors.lastname: Kerr
authors.affiliation: Tropical Pathology and Public Health Institute, Federal University of Goiás, Goiania, Goiás, Brazil.
authors.forename: Mariane Martins de Araújo
authors.initials: MM
authors.lastname: Stefani
authors.affiliation: Tropical Pathology and Public Health Institute, Federal University of Goiás, Goiania, Goiás, Brazil. samira@buhrer.net.
authors.forename: Samira
authors.identifier: http://orcid.org/0000-0002-5984-7770
authors.initials: S
authors.lastname: Bührer-Sékula
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000276:immunology; D001938:Brazil; D002648:Child; D015331:Cohort Studies; D004893:Erythema Nodosum / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005500:Follow-Up Studies; D006017:Glycolipids / Q000276:immunology; D006801:Humans; D007075:Immunoglobulin M / Q000276:immunology*; D007917:Leprostatic Agents / Q000627:therapeutic use*; D015440:Leprosy, Lepromatous / Q000188:drug therapy* / Q000382:microbiology; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000942:Antigens, Bacterial; D006017:Glycolipids; D007075:Immunoglobulin M; D007917:Leprostatic Agents; C045169:phenolic glycolipid I, Mycobacterium leprae
keywords: Bacillary index; Brazil; Clinical trial; Leprosy; Leprosy reactions; ML Flow test; Phenolic glycolipid-I; U-MDT/CT-BR