Shanghai Pharma Biotherapeutics

Feb 7, 2023

Disclosures: Sandborn reports financial relationships with AbbVie, Abivax, AdMIRx, Alfasigma, Alimentiv, Alivio Therapeutics, Allakos, Amgen, Applied Molecular Transport, Arena Pharmaceuticals, Bausch Health, BeiGene, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Celgene, Celltrion, Cellularity, Cosmo Pharmaceuticals, Escalier Biosciences, Equillium, Forbion, Genentech, Gilead Sciences, Glenmark Pharmaceuticals, Gossamer Bio, GSK, Immunic (Vital Therapies), Index Pharmaceuticals, Intact Therapeutics, Janssen, Kyverna Therapeutics, Landos Biopharma, Lilly, Oppilan Pharma, Otsuka, Pandion Therapeutics, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, Provention Bio, Reistone Biopharma, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shire, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tillotts Pharma, UCB, Vedanta Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vivreon Biosciences and Zealand Pharma. Please see the study for all other authors’ relevant financial disclosures. ADD TOPIC TO EMAIL ALERTS Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . Please try again later. If you continue to have this issue please contact customerservice@slackinc.com . Back to Healio Ritlecitinib and brepocitinib induction therapies more effectively reduced total Mayo Score compared with placebo in patients with moderate to severe ulcerative colitis, according to data in Clinical Gastroenterology and Hepatology. “The currently approved small-molecule [Janus kinase (JAK)] inhibitors for treatment of ulcerative colitis include tofacitinib, filgotinib and upadacitinib. The JAK inhibitor selectivity profiles may differentially impact ulcerative colitis , and the link between selective JAK inhibition and an improved benefit/risk profile has yet to be elucidated,” William J. Sandborn, MD, gastroenterologist and professor of medicine at the University of California San Diego, and colleagues wrote. “Ritlecitinib, a JAK3/tyrosine kinase expressed in hepatocellular carcinoma family inhibitor and brepocitinib, a TYK2/JAK1 inhibitor, are oral kinase inhibitors in clinical development.” “Induction therapies with ritlecitinib and brepocitinib were more effective than placebo for treatment of moderate to severe ulcerative colitis, with acceptable short-term safety profiles,” William J. Sandborn, MD, and colleagues wrote.Source: Adobe Stock In the VIBRATO phase 2b, double-blind randomized umbrella study, Sandborn and colleagues assessed the efficacy of ritlecitinib and brepocitinib induction therapy in patients aged 18 to 75 years with moderate to severe UC. Of 317 patients included, 150 received ritlecitinib (20 mg, n = 51; 70 mg, n = 49; 200 mg, n = 50), 142 received brepocitinib (10 mg, n = 48; 30 mg, n = 47; 60 mg, n = 47) and 25 received placebo once daily for 8 weeks. The primary endpoint was total Mayo Score (TMS) at week 8. William J. Sandborn At the end of the study period, mean TMS was 7.9 in the placebo group and 5.9, 4 and 3.3 in the 20-mg, 70-mg and 200-mg ritlecitinib groups, respectively; In the 10-mg, 30-mg and 60-mg brepocitinib groups, mean TMSs were 6.1, 5.6 and 4.7, respectively. Placebo-adjusted mean TMSs were –2 (90% CI, –3.2 to –0.9), –3.9 (90% CI, –5 to –2.7) and –4.6 (90% CI, –5.8 to –3.5) points for ritlecitinib groups, respectively, and –1.8 (90% CI, –2.9 to –0.7), –2.3 (90% CI, –3.4 to –1.1) and –3.2 (90% CI, –4.3 to –2.1) points for brepocitinib groups. Further, the estimated placebo-adjusted proportions of patients with modified clinical remission were 13.7%, 32.7% and 36% for ritlecitinib groups and 14.6%, 25.5% and 25.5% for brepocitinib groups, respectively. Treatment-emergent adverse events occurred in 46.1% of patients, including 43.3% in the ritlecitinib group, 47.9% in the brepocitinib group and 52% in the placebo group. Anemia, headache and nasopharyngitis were among the most reported all-cause adverse events. “Induction therapies with ritlecitinib and brepocitinib were more effective than placebo for treatment of moderate to severe ulcerative colitis , with acceptable short-term safety profiles,” Sandborn and colleagues concluded. Read more about