Upadacitinib Meets Endpoints in Crohn Disease Maintenance Trial
The phase 3 U-ENDURE study included adults with moderate to severe Crohn disease who responded to upadacitinib induction treatment.
The phase 3 U-ENDURE study included adults with moderate to severe Crohn disease who responded to upadacitinib induction treatment.
The PAS is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis.
Open-label placebo may contribute to therapeutic effect in children and adolescents with functional abdominal pain, irritable bowel syndrome
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
Over 60% of the study participants had previously failed 2 or more biologic therapies.
Given that immunogenicity to biologics may contribute to IBD treatment failure, the study authors sought to determine the rate of ADA formation to individual biologic agents.
PillCam SB3 @HOME offers a telehealth option for direct visualization and monitoring of the small intestine.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
The application is supported by data from two phase 3 induction studies (ADVANCE and MOTIVATE) and one phase 3 maintenance study (FORTIFY).
Investigators assessed trends in corticosteroid use in patients with IBD over a period of 20 years.