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

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.

Reference

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.