TY - JOUR
T1 - Surveillance of adverse events in the treatment of drug-resistant tuberculosis
T2 - A global feasibility study
AU - The members of the International Study Group on new anti-tuberculosis drugs and adverse events monitoring
AU - Akkerman, Onno
AU - Aleksa, Alena
AU - Alffenaar, Jan Willem
AU - Al-Marzouqi, Nada Hassan
AU - Arias-Guillén, Miguel
AU - Belilovski, Evgeny
AU - Bernal, Enrique
AU - Boeree, Martin J.
AU - Borisov, Sergey E.
AU - Bruchfeld, Judith
AU - Cadiñanos Loidi, Julen
AU - Cai, Qingshan
AU - Caminero, Jose A.
AU - Cebrian Gallardo, Jose Joaquín
AU - Centis, Rosella
AU - Codecasa, Luigi Ruffo
AU - D'Ambrosio, Lia
AU - Dalcolmo, Margareth
AU - Danila, Edvardas
AU - Dara, Masoud
AU - Davidavičienė, Edita
AU - Davies Forsman, Lina
AU - De Los Rios Jefe, Jorge
AU - Denholm, Justin
AU - Duarte, Raquel
AU - Elamin, Seifeldin Eltaeb
AU - Ferrarese, Maurizio
AU - Filippov, Alexey
AU - Ganatra, Shashank
AU - Garcia, Ana
AU - García-García, José María
AU - Gayoso, Regina
AU - Giraldo Montoya, Angela Maria
AU - Gomez Rosso, Roscio Gomez
AU - Gualano, Gina
AU - Hoefsloot, Wouter
AU - Ilievska-Poposka, Biljana
AU - Jonsson, Jerker
AU - Khimova, Elena
AU - Kunst, Heinke
AU - Laniado-Laborín, Rafael
AU - Li, Yang
AU - Magis-Escurra, Cecile
AU - Manfrin, Vinicio
AU - Manga, Selene
AU - Marchese, Valentina
AU - Martínez Robles, Elena
AU - Maryandyshev, Andrei
A2 - Kuksa, Liga
A2 - Šmite, Agnese
N1 - Publisher Copyright:
© 2019
PY - 2019/6
Y1 - 2019/6
N2 - 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.
AB - 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.
KW - Adverse events
KW - Bedaquiline
KW - Delamanid
KW - MDR-TB
KW - Monitoring
KW - Tuberculosis
UR - http://www.scopus.com/inward/record.url?scp=85065097630&partnerID=8YFLogxK
U2 - 10.1016/j.ijid.2019.03.036
DO - 10.1016/j.ijid.2019.03.036
M3 - Article
C2 - 30953827
AN - SCOPUS:85065097630
SN - 1201-9712
VL - 83
SP - 72
EP - 76
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
ER -