Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study

•WHO recommends countries monitor the safety profile of new drugs and regimens.•WHO developed the active TB drug safety monitoring and management (aDSM) package.•aDSM data are not yet available globally.•A project to prove aDSM feasibility was launched by the Global Tuberculosis Network; 41 centres...

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Published in:	International Journal of Infectious Diseases Vol. 83; pp. 72 - 76
Main Authors:	Akkerman, Onno, Aleksa, Alena, Alffenaar, Jan-Willem, Al-Marzouqi, Nada Hassan, Arias-Guillén, Miguel, Belilovski, Evgeny, Bernal, Enrique, Boeree, Martin J., Borisov, Sergey E., Bruchfeld, Judith, Cadiñanos Loidi, Julen, Cai, Qingshan, Caminero, Jose A., Cebrian Gallardo, Jose Joaquín, Centis, Rosella, Codecasa, Luigi Ruffo, D’Ambrosio, Lia, Dalcolmo, Margareth, Danila, Edvardas, Dara, Masoud, Davidavičienė, Edita, Davies Forsman, Lina, De Los Rios Jefe, Jorge, Denholm, Justin, Duarte, Raquel, Elamin, Seifeldin Eltaeb, Ferrarese, Maurizio, Filippov, Alexey, Ganatra, Shashank, Garcia, Ana, García-García, José-María, Gayoso, Regina, Giraldo Montoya, Angela Maria, Gomez Rosso, Roscio Gomez, Gualano, Gina, Hoefsloot, Wouter, Ilievska-Poposka, Biljana, Jonsson, Jerker, Khimova, Elena, Kuksa, Liga, Kunst, Heinke, Laniado-Laborín, Rafael, Li, Yang, Magis-Escurra, Cecile, Manfrin, Vinicio, Manga, Selene, Marchese, Valentina, Martínez Robles, Elena, Maryandyshev, Andrei, Matteelli, Alberto, Migliori, Giovanni Battista, Mullerpattan, Jai B., Munoz-Torrico, Marcela, Mustafa Hamdan, Hamdan, Nieto Marcos, Magnolia, Noordin, Noorliza Mohamad, Palmero, Domingo Juan, Palmieri, Fabrizio, Payen, Marie-Christine, Piubello, Alberto, Pontali, Emanuele, Pontarelli, Agostina, Quirós, Sarai, Rendon, Adrian, Skrahina, Alena, Šmite, Agnese, Solovic, Ivan, Sotgiu, Giovanni, Souleymane, Mahamadou Bassirou, Spanevello, Antonio, Stošić, Maja, Tadolini, Marina, Tiberi, Simon, Udwadia, Zarir Farokh, van den Boom, Martin, Vescovo, Marisa, Viggiani, Pietro, Visca, Dina, Zhurkin, Dmitry, Zignol, Matteo
Format:	Journal Article
Language:	English
Published:	Canada Elsevier Ltd 01.06.2019 Elsevier BV Elsevier
Subjects:	Adverse events Adverse events; Bedaquiline; Delamanid; MDR-TB; Monitoring; Tuberculosis Adverse events; Bedaquiline; Delamanid; MDR-TB; Monitoring; Tuberculosis; Antitubercular Agents; Diarylquinolines; Drug Therapy, Combination; Feasibility Studies; Female; Humans; Male; Nitroimidazoles; Oxazoles; Pilot Projects; Tuberculosis; Tuberculosis, Multidrug-Resistant; World Health Organization Antitubercular Agents Bedaquiline Delamanid Diarylquinolines Drug Therapy, Combination Feasibility Studies Female Humans Infectious and parasitic diseases Male MDR-TB Microbiologie et protistologie [bacteriol.virolog.mycolog.] Microbiologie et protistologie [entomologie,phytoparasitolog.] Microbiologie et protistologie [parasitologie hum. et anim.] Monitoring Nitroimidazoles Oxazoles Pathologie maladies infectieuses Pilot Projects RA Aspectos Públicos de la Medicina Radboudumc 4: lnfectious Diseases and Global Health RIHS: Radboud Institute for Health Sciences RC109-216 Tuberculosis Tuberculosis, Multidrug-Resistant World Health Organization MDR-TB Tuberculosis Adverse events Delamanid Monitoring Bedaquiline
ISSN:	1201-9712, 1878-3511, 1878-3511
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Summary:	•WHO recommends countries monitor the safety profile of new drugs and regimens.•WHO developed the active TB drug safety monitoring and management (aDSM) package.•aDSM data are not yet available globally.•A project to prove aDSM feasibility was launched by the Global Tuberculosis Network; 41 centres in 27 countries participated.•309 cases were fully reported as of February 2019 out of 781 cases countries committed to report in 2019. The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries. The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs. Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile. A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1201-9712 1878-3511 1878-3511
DOI:	10.1016/j.ijid.2019.03.036