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Lancet Gastroent Hepatol: BI 695501, a potential new treatment option for Crohn's disease!

 Last Update: 2021-08-27
 Source: Internet
 Author: User

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BI 695501 is a biological generic, in rheumatoid arthritis showed the Adalimumab reference product similar efficacy, safety, and chronic plaque psoriasis patients immunized immunogenic

BI 695501 is a biological generic, in rheumatoid arthritis showed the Adalimumab reference product similar efficacy, safety, and chronic plaque psoriasis patients immunized immunogenic rheumatoid arthritis immunity

This is a randomized, double-blind phase 3 trial conducted in 92 centers in 12 countries, recruiting 18-80-year-old patients with moderate to severe active Crohn’s disease (Crohn’s disease activity index [CDAI] score 220 -450 points)

Remission of each group

From January 4, 2017 to April 5, 2018, a total of 147 patients were recruited and randomly assigned to the BI 695501 group (n=72) or the Adalimumab group (n=75)

At week 4, 61 (90%) of 68 patients in the BI 695501 group and 68 (94%) of 72 patients in the adalimumab group achieved clinical remission (adjusted RR 0.

The occurrence of adverse events in each group

In the safety analysis department, 63% (45/72) and 56% (42/75) of the patients in the BI 695501 group and the adalimumab group had adverse events in the first 24 weeks; week 24-56, Adverse events occurred in 43% and 45% of patients in the two groups, respectively

In the BI 695501 group and adalimumab group, 63% (45/72) and 56% (42/75) of the patients had adverse events in the first 24 weeks, respectively; in the 24-56 week, 43% and 56% of the patients in the two groups had adverse events.

There were 6 cases (8%) and 8 cases (11%) of serious adverse events in the BI 695501 group and adalimumab group respectively in the first 24 weeks, and 2 cases (3%) and 9 cases occurred in the 24-56 week period.

Compared with the reference product of adalimumab, the safety and efficacy of BI 695501 for patients with Crohn's disease are similar.

Original source:

Stephen Hanauer, et al.

Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial

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