All-case post-marketing surveillance of delamanid for treating multidrug-resistant pulmonary tuberculosis in Japan.
Delamanid is a nitro-dihydro-imidazooxazole derivative that possesses highly potent activity against Mycobacterium tuberculosis, including strains linked to multidrug-resistant tuberculosis (MDR-TB). We conducted an all-case post-marketing surveillance to assess the real-world safety and effectiveness of delamanid in treating MDR-TB in Japan.
All patients diagnosed with MDR-TB were included if they started delamanid between September 2014 and February 2023. Case report forms were collected every 6 months during the treatment period and every 12 months during the follow-up period. Safety assessment included any adverse events that occurred during the treatment period. Effectiveness assessment included the proportion of patients with sputum-culture conversion and treatment success.
In the safety analysis set, 61.6 % of patients (114/185) were males, and the median (interquartile range) age was 48.0 (32.0, 64.0) years. During the treatment period, 54.05 % of patients (100/185) experienced adverse drug reactions (ADRs), and 8.65 % (16/185) experienced serious ADRs. Electrocardiogram QT prolongation was reported in 8.65 % of patients (16/185) but was not associated with an increased risk of cardiovascular events. In the sputum-culture conversion analysis set, sputum-culture conversion was achieved in 86.0 % of patients (80/93). In the effectiveness analysis set, treatment success was achieved in 54.1 % of patients (99/183) by the end of the treatment period.
This surveillance showed the effectiveness of ≥6 months of delamanid treatment among patients with MDR-TB in real-world settings in Japan, with no new safety issues identified.
All patients diagnosed with MDR-TB were included if they started delamanid between September 2014 and February 2023. Case report forms were collected every 6 months during the treatment period and every 12 months during the follow-up period. Safety assessment included any adverse events that occurred during the treatment period. Effectiveness assessment included the proportion of patients with sputum-culture conversion and treatment success.
In the safety analysis set, 61.6 % of patients (114/185) were males, and the median (interquartile range) age was 48.0 (32.0, 64.0) years. During the treatment period, 54.05 % of patients (100/185) experienced adverse drug reactions (ADRs), and 8.65 % (16/185) experienced serious ADRs. Electrocardiogram QT prolongation was reported in 8.65 % of patients (16/185) but was not associated with an increased risk of cardiovascular events. In the sputum-culture conversion analysis set, sputum-culture conversion was achieved in 86.0 % of patients (80/93). In the effectiveness analysis set, treatment success was achieved in 54.1 % of patients (99/183) by the end of the treatment period.
This surveillance showed the effectiveness of ≥6 months of delamanid treatment among patients with MDR-TB in real-world settings in Japan, with no new safety issues identified.
Authors
Mori Mori, Tsuyuguchi Tsuyuguchi, Saito Saito, Sasaki Sasaki, Shigeto Shigeto, Nagai Nagai, Komaniwa Komaniwa, Hashizume Hashizume, Suzue Suzue, Yamashige Yamashige, Yoshiyama Yoshiyama
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