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.
Crohn Disease
FDA to Review Abrilada for Interchangeability With Humira
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 Studied in Children With Abdominal Pain, IBS
Open-label placebo may contribute to therapeutic effect in children and adolescents with functional abdominal pain, irritable bowel syndrome
Yusimry, a Humira Biosimilar Product, Gets FDA Approval
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
Clinical Remission, Endoscopic Response Seen With Upadacitinib in Crohn Disease Trial
Over 60% of the study participants had previously failed 2 or more biologic therapies.
Study Investigates Rate of Antidrug Antibody Formation to Biologics Used in IBD
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.
FDA Clears System That Allows for Remote Endoscopy Procedures
PillCam SB3 @HOME offers a telehealth option for direct visualization and monitoring of the small intestine.
First Interchangeable Biosimilar to Humira Gets FDA Approval
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
AbbVie Seeks Approval of Risankizumab for Crohn Disease
The application is supported by data from two phase 3 induction studies (ADVANCE and MOTIVATE) and one phase 3 maintenance study (FORTIFY).
Corticosteroid Use Declines in Patients With IBD Over Past 20 Years
Investigators assessed trends in corticosteroid use in patients with IBD over a period of 20 years.
