Ustekinumab Efficacy in a Real-World Setting of Patients With Difficult-to-Treat Crohn Disease

Investigators assessed the efficacy and clinical effects of ustekinumab in patients with Crohn disease who had a previously failed anti-TNF therapy attempt.

The following article is a part of conference coverage from the Advances in Inflammatory Bowel Diseases 2021 Annual Meeting , held from December 9 to 11, 2021. The team at Gastroenterology Advisor will be reporting on the latest news and research conducted by leading experts in gastroenterology. Check back for more from AIBD 2021.


Remission rates were found to be high after ustekinumab induction among patients with Crohn disease (CD) who had a previously failed anti-tumor necrosis factor (TNF) therapy attempt, according to research presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2021 Annual Meeting, held from December 9 to 11, 2021, in Orlando, Florida and virtually.

Ustekinumab, a monoclonal antibody against the interleukin (IL)-12/23 subunit p40, was approved for the treatment of moderate to severe CD and ulcerative colitis. In order to assess its efficacy among a cohort of patients with a prior failed anti-TNF therapy attempt, researchers from the University of Massachusetts Medical School in the United States retrospectively reviewed patient records for evidence of ustekinumab efficacy.

A total of 34 patients were found to have ³1 failed anti-TNF treatment prior to induction with ustekinumab. The patient cohort consisted of 59% women and 50% had fistulizing disease.

Clinical remission was achieved by 70.5% of patients. Among those in remission, 29% were on concomitant steroids or immunomodulators at the time of remission. The proportion of patients with fistulizing disease who achieved remission was 70%.

Among patients with data on C-reactive protein levels (70%), the average level prior to ustekinumab induction was 2.4, which trended downward to 1.98 (95% CI, -0.064 to 1.08; P =.079) after starting therapy.

Among the patients with fecal calprotectin data (18%), mean fecal calprotectin levels prior to ustekinumab induction were 386. Like C-reactive protein, fecal calprotectin also trended downward after ustekinumab exposure (mean, 175; 95% CI, -106.25 to 528.46; P =.148).

This study found that ustekinumab was associated with a high rate of remission, even for patients with fistulizing CD, among a difficult to treat population who had prior failed anti-TNF therapy. In addition, these data indicated that fecal calprotectin sampling compliance was low among this patient population.

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Kartikeya T, Kevin G, Jean C, Arushika Y, Rohit S. Real-world experience of ustekinumab in Crohn’s disease patients with prior anti-TNF therapy at a tertiary care hospital. Presented at: AIBD 2021 Annual Meeting; December 9-11, 2021; Orlando, FL and virtual. Abstract P067.