FDA to Review Biosimilar Hyrimoz High Concentration Formulation
The sBLA is supported by data from a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50mg/mL and citrate-free Hyrimoz HCF.
Ulcerative Colitis
Concomitant PPI and Advanced Therapy Linked to Worse Outcomes in IBD
A team of investigators evaluated the effects of concomitant use of PPIs and advanced therapy on health care resources in patients with IBD.
Mucosa, C-Reactive Proteins Predict Ulcerative Colitis Relapse
Normalization of 2 factors can foretell the potential for recurrence in patients who were in remission, according to a report.
Antibiotic Use Increases Risk for Older-Onset Inflammatory Bowel Disease
Researchers evaluated the effects of antibiotic exposure, specifically cumulative use, timing of use, and the association with older-onset IBD.
Tofacitinib, Vedolizumab Effective for UC Post-Anti-TNF Agent Failure
Researchers compared the effectiveness of tofacitinib and vedolizumab among patients with UC who had experienced anti-TNF failure.
New Indication: Rinvoq for Ulcerative Colitis
This slideshow shows drug information for the new ulcerative colitis indication for Rinvoq. Click here for the complete Rinvoq monograph.
Improvements in Clinical Remission Seen With Etrasimod in UC Trial
The phase 3 ELEVATE 12 trial evaluated the efficacy and safety of etrasimod 2mg once daily vs placebo in 354 patients.
Rinvoq Approved for Moderately to Severely Active Ulcerative Colitis
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
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.
