Publication

Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report

Borisov, S., Danila, E., Maryandyshev, A., Dalcolmo, M., Miliauskas, S., Kuksa, L., Manga, S., Skrahina, A., Diktanas, S., Codecasa, L. R., Aleksa, A., Bruchfeld, J., Koleva, A., Piubello, A., Udwadia, Z. F., Akkerman, O. W., Belilovski, E., Bernal, E., Boeree, M. J., Loidi, J. C., Cai, Q., Cebrian Gallardo, J. J., Dara, M., Davidavičienė, E., Forsman, L. D., De Los Rios Jefe, J., Denholm, J., Drakšienė, J., Duarte, R., Elamin, S. E., Salinas, N. E., Ferrarese, M., Filippov, A., Garcia, A., García-García, J-M., Gaudiesiute, I., Gavazova, B., Gayoso, R., Rosso, R. G., Gruslys, V., Gualano, G., Hoefsloot, W., Jonsson, J., Khimova, E., Kunst, H., Laniado-Laborín, R., Li, Y., Magis-Escurra, C., Manfrin, V., Marchese, V., Robles, E. M., Matteelli, A., Mazza-Stalder, J., Moschos, C., Munoz-Torrico, M., Hamdan, H. M., Nakčerienė, B., Nicod, L., Marcos, M. N., Palmero, D. J., Palmieri, F., Papavasileiou, A., Payen, M-C., Pontarelli, A., Quirós, S., Rendon, A., Saderi, L., Šmite, A., Solovic, I., Souleymane, M. B., Tadolini, M., van den Boom, M., Vescovo, M., Viggiani, P., Yedilbayev, A., Zablockis, R., Zhurkin, D., Zignol, M., Visca, D., Spanevello, A., Caminero, J. A., Alffenaar, J-W., Tiberi, S., Centis, R., D'Ambrosio, L., Pontali, E., Sotgiu, G. & Migliori, G. B., 2019, In : European Respiratory Journal. 14 p.

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DOI

  • Sergey Borisov
  • Edvardas Danila
  • Andrei Maryandyshev
  • Margareth Dalcolmo
  • Skaidrius Miliauskas
  • Liga Kuksa
  • Selene Manga
  • Alena Skrahina
  • Saulius Diktanas
  • Luigi Ruffo Codecasa
  • Alena Aleksa
  • Judith Bruchfeld
  • Antoniya Koleva
  • Alberto Piubello
  • Zarir Farokh Udwadia
  • Onno W Akkerman
  • Evgeny Belilovski
  • Enrique Bernal
  • Martin J Boeree
  • Julen Cadiñanos Loidi
  • Qingshan Cai
  • Jose Joaquín Cebrian Gallardo
  • Masoud Dara
  • Edita Davidavičienė
  • Lina Davies Forsman
  • Jorge De Los Rios Jefe
  • Justin Denholm
  • Jacinta Drakšienė
  • Raquel Duarte
  • Seifeldin Eltaeb Elamin
  • Nadia Escobar Salinas
  • Maurizio Ferrarese
  • Aleksey Filippov
  • Ana Garcia
  • José-María García-García
  • Ieva Gaudiesiute
  • Blagovesta Gavazova
  • Regina Gayoso
  • Roscio Gomez Rosso
  • Vygantas Gruslys
  • Gina Gualano
  • Wouter Hoefsloot
  • Jerker Jonsson
  • Elena Khimova
  • Heinke Kunst
  • Rafael Laniado-Laborín
  • Yang Li
  • Cecile Magis-Escurra
  • Vinicio Manfrin
  • Valentina Marchese
  • Elena Martínez Robles
  • Alberto Matteelli
  • Jesica Mazza-Stalder
  • Charalampos Moschos
  • Marcela Munoz-Torrico
  • Hamdan Mustafa Hamdan
  • Birutė Nakčerienė
  • Lauren Nicod
  • Magnolia Nieto Marcos
  • Domingo Juan Palmero
  • Fabrizio Palmieri
  • Apostolos Papavasileiou
  • Marie-Christine Payen
  • Agostina Pontarelli
  • Sarai Quirós
  • Adrian Rendon
  • Laura Saderi
  • Agnese Šmite
  • Ivan Solovic
  • Mahamadou Bassirou Souleymane
  • Marina Tadolini
  • Martin van den Boom
  • Marisa Vescovo
  • Pietro Viggiani
  • Askar Yedilbayev
  • Rolandas Zablockis
  • Dmitry Zhurkin
  • Matteo Zignol
  • Dina Visca
  • Antonio Spanevello
  • Jose A Caminero
  • Jan-Willem Alffenaar
  • Simon Tiberi
  • Rosella Centis
  • Lia D'Ambrosio
  • Emanuele Pontali
  • Giovanni Sotgiu
  • Giovanni Battista Migliori

WHO (World Health Organization) recommends countries to implement pharmacovigilance and to collect information on aDSM (active drug safety monitoring and management of adverse events-AEs).Aim of this prospective study was to evaluate the frequency and severity of AEs to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project.AEs were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% males, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall 504 AE episodes were reported: 447 (447/504, 88.7%) were classified as minor (grade 1-2) and 57 (57/504, 11.3%) as serious (grade 3-5).The majority of the 57 serious AEs reported by 55 patients (51/57; 89.5%) ultimately resolved. Among patients reporting serious AEs some drugs held responsible were discontinued: bedaquiline in 0.35% (2/577), delamanid in 0.8% (1/121), linezolid in 1.9% (10/536) and clofazimine in 1.4% (3/213) of patients.Serious AEs were reported in 6.9% (9/131) of patients treated with amikacin, 0.4% (1/221) with ethionamide/prothionamide, 2.8% (15/536) with linezolid and 1.8% (8/498) with cycloserine/terizidone.The aDSM study provided valuable information but implementation needs scaling-up to support patient-centred care.

Original languageEnglish
Number of pages14
JournalEuropean Respiratory Journal
Publication statusE-pub ahead of print - 2019

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