Dose intensification of ustekinumab appears to be safe and effective in patients with
ulcerative colitis (UC), according to a real-world multicenter cohort study published in Clinical Gastroenterology and Hepatology.
More than 40% of patients have a suboptimal clinical response after induction and maintenance dosing every 8 weeks (q8w) with ustekinumab for the treatment of UC. While ustekinumab dose intensification in patients with Crohn Disease appears to be effective, data in patients with UC is lacking. Therefore, researchers aimed to identify predictors and outcomes of ustekinumab dose intensification in 108 patients with UC.
Investigators found that 39.6% (40/101) of patients achieved remission 12-16 weeks after induction. However, 42.6% (46/108) required intensification to q4w (n=33) or q6w (n=13) after a median of 95 days, primarily for no/minimal response to induction (22/46) or loss of response (20/46).
IV reinduction doses were administered to 4/46 patients preceding intensification. At 12-16 weeks after intensification, 55.0% (22/40) of patients achieved remission and 67.5% (27/40) achieved response. Thirty percent (12/40) of patients had drug discontinuation or colectomy within 16 weeks after intensification, and among these, 10/12 had no/minimal response to induction and 2/12 had loss of response.
Over a median follow-up of 230 days after intensification, the researchers found that 56.3% (9/16) of patients had improvement in endoscopic inflammation and fecal calprotectin, 10.0% (4/40) had IBD-related hospitalization, and 5.0% (2/40) had adverse events (urinary tract infection and Clostridioides difficile infection).
After a multivariable analysis, no/minimal response to induction was inversely associated with remission after intensification. Bowel frequency and more than two prior biologic exposures were associated with time to intensification.
“In summary, ustekinumab dose intensification appears to be safe and effective for patients with UC,” stated the authors. They added, “Prospective studies may identify specific subpopulations that would benefit from different optimization strategies of ustekinumab in UC.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Dalal RS, Esckilsen S, Barnes EL, Pruce JC, Marcus J, Allegretti JR. Predictors and outcomes of ustekinumab dose intensification in ulcerative colitis: a multicenter cohort study. Clin Gastroenterol Hepatol. Published online March 25, 2021. doi: 10.1016/j.cgh.2021.03.028