Stelara dose escalation effective, safe in luminal, perianal Crohn’s disease
AUSTIN, Texas — Real-world dose escalation of Stelara was safe and effective in patients with perianal Crohn’s disease, according to data presented at Crohn’s and Colitis Congress.
“Standard ustekinumab dosing is every 8 weeks for moderate to severe Crohn’s disease, but in real-world practice a lot of physicians will dose escalate to every 4 or every 6 weeks in patients who aren’t meeting a clinical response,” Jason Glass, MD, a fellow at University of Texas Southwestern Medical Center, told Healio Gastroenterology and Liver Disease. “But there’s not a lot of evidence to support going from every 8 to every 6 or 4 weeks; it’s all limited to small retrospective studies or abstract data, so the impetus for our study was to look at [a] subset of patients [at] UT Southwestern and health outcomes when we dose escalated these patients to every 6 or every 4 weeks.”
To report real-world experience with Stelara (ustekinumab, Janssen) dose escalation for luminal and perianal Crohn’s disease, Glass and colleagues conducted a single center retrospective cohort study of 38 patients (median age, 38 years) who were prescribed ustekinumab between 2016 and 2019.
Steroid-free clinical response, objective improvement in disease activity on follow-up CT, MRI or endoscopy; or normalization of C-reactive protein served as the primary outcome.
Additional primary outcome was an improvement in perianal disease.
Adverse events and IBD-related surgery were secondary endpoints.
The study comprised patients who received ustekinumab dosing increased from 90 mg subcutaneous every 8 weeks to every 4 or 6 weeks.
More than half of the patients (63%) had active perianal disease and 65% of patients had a previous IBD-related surgery.
Eighteen patients had a primary non-response to on-label dosing and the median time to dose escalation was 10 months.
Sixty percent of patients experienced a composite disease response. Sixty percent of patients (n = 10) experienced steroid-free response, 73% had endoscopic improvement (n = 11), 50% had radiologic improvement (n = 12) and 27% had a normalization of C-reactive protein (n = 33).
Half of the patients (n = 24) experienced an improvement in perianal disease.
“We found that dose escalation was efficacious in both perianal disease and in our composite outcome,” Glass said in an interview. “The potential implications are that this may support the real-world escalation of ustekinumab dosing. Other biologics, like anti-TNFs there’s more evidence to support dose escalation of those drugs, but in the future as more data come in, dose escalation of ustekinumab will probably be supported in the guidelines. This provides more evidence to use ustekinumab for perianal disease as well.”
Five percent of patients reported experiencing an adverse event, which Glass said was similar to other studies and none were considered serious.
Glass noted that there are plans to further the research and conduct a meta-analysis or a systematic review.
“Our cohort overall is 38 patients; it’s not a large study, but in the future, we plan on expanding to multiple centers to create a larger population,” he said. – by Ryan McDonald
Glass J, et al. Abstract 26. Presented at: Crohn’s and Colitis Congress; Jan. 23-25, 2020; Austin, Texas.
Disclosure: The authors report no relevant financial disclosures.