American College of Gastroenterology Annual Meeting

American College of Gastroenterology Annual Meeting

October 10, 2018
2 min read

Immunomodulators not necessary with long-term Stelara therapy in Crohn’s

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Bruce E. Sands
Bruce E. Sands

PHILADELPHIA — Concomitant immunomodulator use is not necessary with Stelara therapy for Crohn’s disease, according to long-term data from the IM-UNITI LTE study presented at the American College of Gastroenterology Annual Meeting.

“The ongoing immunity long-term extension study evaluates the efficacy and safety of subcutaneous ustekinumab through approximately five years of treatment,” Bruce E. Sands, MD, MS, from the Icahn School of Medicine at Mount Sinai, said during his presentation. “Results through week 44 of maintenance previously demonstrated no apparent benefit of concomitant immunomodulators on efficacy, drug levels or immunogenicity.”

These data represent results through two years of the study.

Sands and colleagues enrolled 1,281 patients in the maintenance study, including 397 patients who responded to Stelara (ustekinumab, Janssen) during induction. Their analysis included 82 patients on ustekinumab from the primary population who did not meet loss of response criteria for dose adjustment and were entered into the long-term extension. Investigators assessed clinical remission at each visit, serum ustekinumab concentrations for weeks 44 to 92, and determined immunogenicity for patients taking vs. not taking concomitant immunomodulators (IMM).

Of 82 patients, 29 were taking concomitant IMM (35.4%), and the 53 patients that were not on IMM at baseline all remained off them through week 92 (64.6%).

Researchers found that remission rates in the non-IMM group were not significantly higher than in the IMM group at week 92 (75.4% vs. 72.41%). Additionally, they found no evidence that IMMs had any noticeable effect of serum ustekinumab or antidrug-antibody formation at any of the study’s timepoints.

Sands said their findings support the notion that concomitant IMM use with ustekinumab is not necessary.

“As was seen at one year, immunomodulator at baseline does not affect patient outcomes through two years in those patients treated with ustekinumab every eight weeks in the long-term extension,” he said. “The rates of antibodies to ustekinumab remained low throughout two years regardless of whether or not the patients were or were not taking immunomodulators. This is in contrast to findings with some other biologic agents where use of immunomodulators in combination is important.”by Alex Young

Reference : Sands BE, et al. Abstract 49. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 5-10, 2018; Philadelphia.

Disclosure: Sands reports financial ties to Janssen. Please see the full study for all other authors relevant financial disclosures.