Hanauer S, Liedert B, Balser S, et al. - According to this phase 3, randomised, double-blind study, in Crohn disease patients treated with BI 695501 or adalimumab reference product, safety and efficacy were similar. Patients who moved from adalimumab reference product to BI 695501 retained their treatment advantages. Such findings support BI 695501's current approval as an alternative to the adalimumab reference product for patients with Crohn disease, as well as the other indications for which it is approved.

• One hundred forty-seven patients were recruited and randomly assigned to BI 695501 (n = 72) or adalimumab reference product (n = 75) between January 4, 2017, and April 5, 2018.

• Weight gain, injection-site erythema, and upper respiratory tract infection were the most prevalent drug-related treatment-emergent adverse events in the adalimumab reference product group throughout weeks 0–24.

• During weeks 24–56, the only drug-related TEAEs recorded in two or more patients were weight gain and elevated γ-glutamyltransferase, which occurred in two (3%) patients each in the BI 695501 group.

• During weeks 24–56, no drug-related TEAEs were observed in two or more patients in the adalimumab reference product group, which was followed by the BI 699501 group.

• Between weeks 0–24, six (8%) patients in the BI 695501 group and eight (11%) in the adalimumab reference group experienced serious adverse events, while between weeks 24–56, two (3%) and nine (12%) patients experienced serious adverse events.

• During weeks 0–24, two (3%) patients in each treatment group experienced adverse events of special interest (acute sinusitis and pulmonary tuberculosis in the BI 695501 group and anal abscess and postoperative wound infection in the adalimumab reference product group), and two (3%) patients in each treatment group experienced adverse events of special interest during weeks 24–56 (psoas abscess and hypersensitivity in the BI 695501 group and pulmonary tuberculosis and erythematous rash in the adalimumab reference product followed by BI 699501 group).