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.
Investigators assessed the effects of 300 mg daily thiamine on maintaining levels of fatigue in patients with IBD previously receiving high-dose thiamine.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
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.
Due to the relatively high relapse rate and need for additional therapies, current research is being done on the use of Vedolizumab for the treatment of microscopic colitis.
Investigators conducted an open-label extension to evaluate the long-term safety and efficacy of risankizumab for the treatment of moderate to severe Crohn disease.
