Crohn's Disease
FDA approves biosimilar Pyzchiva for all approved Stelara indications
The FDA has approved the Stelara biosimilar Pyzchiva for psoriatic arthritis, Crohn’s disease and all other indications approved for the reference medicine, according to a press release from Sandoz.
Hormone replacement therapy improves IBD symptoms in postmenopausal women
Hormone replacement therapy was associated with improved disease symptoms, measured by the physician global assessment score, in a cohort of postmenopausal women with inflammatory bowel disease, according to data.
Higher adalimumab concentration linked to complete healing in perianal fistulizing Crohn’s
An adalimumab concentration threshold of 12.1 µg/mL “may be a target for therapeutic drug monitoring” to achieve complete fistula healing in perianal fistulizing Crohn’s disease, according to research in Clinical Gastroenterology and Hepatology.
Skyrizi snags FDA approval for moderate to severe UC; first IL-23 approved for UC, CD
The FDA has approved Skyrizi for the treatment of adult patients with moderate to severe ulcerative colitis, making it the first interleukin-23 specific inhibitor approved for both UC and Crohn’s disease, AbbVie reported.
‘Promise of lasting efficacy’: Guselkumab outperforms placebo, ustekinumab in Crohn’s
WASHINGTON — In patients with active Crohn’s disease, guselkumab was superior to both placebo and standard-of-care ustekinumab after 48 weeks of treatment, according to late-breaking data from the phase 3 GALAXI program.
VIDEO: ‘Compelling data’ from VIVID-1 study support use of mirikizumab in Crohn’s disease
WASHINGTON — In this video, Mark Genovese, MD, discusses results of the VIVID-1 study, in which mirikizumab demonstrated noninferiority to ustekinumab for week 52 clinical remission among patients with moderate to severe Crohn’s disease.
A catered low-fat, high-fiber diet ‘new, hopeful option’ to manage Crohn’s disease
WASHINGTON — Patients with Crohn’s disease who ate a catered low-fat, high-fiber diet for 8 weeks experienced improvements in symptoms, inflammation and quality of life vs. those offered counseling alone, researchers reported.
Entyvio effective in pediatric IBD, ‘should be included in our treatment paradigm’
WASHINGTON — Entyvio is “safe and effective” for maintaining sustained steroid-free remission at 1 year in children with inflammatory bowel disease, more so in those with ulcerative colitis vs. Crohn’s disease, according to a researcher.
‘Unexpectedly high’ placebo response derails darvadstrocel for Crohn’s perianal fistulas
WASHINGTON — Darvadstrocel demonstrated “no statistically significant or clinically meaningful” benefit vs. placebo for complex perianal fistulas and Crohn’s disease, according to ADMIRE-CD II trial data presented at Digestive Disease Week.
Simlandi launches in U.S. as third interchangeable Humira biosimilar
Simlandi injection, an interchangeable biosimilar to Humira, is now available in the U.S. for the treatment of psoriatic arthritis, plaque psoriasis and other conditions, Teva Pharmaceuticals and Alvotech announced in a press release.