Stelara demonstrates safety, efficacy in highly refractory Crohn’s disease

SAN DIEGO — Ustekinumab resulted in clinical remission of Crohn’s disease in more than half of patients in a large, highly refractory cohort, according to a study presented at Digestive Disease Week.

“Ustekinumab (Stelara, Janssen) is a monoclonal antibody targeting interleukins 12 and 23,” Marisa Iborra, MD, PhD, from Hospital Universitario La Fe, in Valencia, Spain, and colleagues wrote. “Its effectiveness in clinical practice has not yet been demonstrated. The aim of this study was to assess the real-world, short-term effectiveness of ustekinumab in medically refractory Crohn’s disease.”

Iborra and colleagues examined 305 patients with Crohn’s disease who were administered ustekinumab after June 2017, when the agent was approved in Spain. All patients received the recommended dose of ustekinumab: a 6 mg/kg IV infusion and a 90 mg subcutaneous injection at week 8.

Clinical remission was measured using the Harvey Bradshaw Index (HBI) and was defined as a score of 4 or less. The researchers documented HBI, C-reactive protein and fecal calprotectin measurements at baseline, week 8 and week 14. They also recorded data on demographics, clinical information, endoscopies at baseline when available, prior therapies, side effects and hospitalizations. Factors that may predict clinical remission were also assessed.

At the start of the study, nearly three-quarters of patients (72%) had an HBI score of more than 4. Clinical remission was reached in 47% of these patients at week 8 and 58% at week 14. There were 109 patients taking corticosteroids at the beginning of the study; by week 14, 52 of these patients (48%) were in corticosteroid-free remission.

Fecal calprotein values normalized (<250 µg/g) among 22% of patients at week 8 and 24% of patients at week 14, while CRP values normalized (<3 mg/L) among 40% of patients at week 8 and 35% of patients at week 14.

Twelve percent of patients experienced adverse events. Overall, 40 patients needed to be hospitalized; seven of these admissions were due to adverse events.

The researchers found that clinical remission at week 14 was related to the inability to tolerate the most recently prescribed anti-TNF agent and prior exposure to fewer anti-TNF agents. Endoscopic severity, but not prior treatment with vedolizumab, correlated with poor response.

“This is the first study to show the real-world safety and effectiveness of ustekinumab in a large cohort of highly refractory Crohn’s disease patients,” Iborra and colleagues concluded. – by Alaina Tedesco

Reference:

Iborra M, et al. Su1865. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.

Disclosures: Iborra reports no relevant financial disclosures. Please see the abstract for all other author’s relevant financial disclosures.