Shortening Ustekinumab Interval to Every 4 Weeks Associated With Increased Rates of Clinical and Biological Remission in Patients With Crohn’s Disease

Shortening Ustekinumab Interval to Every 4 Weeks Associated With Increased Rates of Clinical and Biological Remission in Patients With Crohn’s Disease

Monika Fischer, MD, reviewing Ollech JE, et al. Clin Gastroenterol Hepatol 2020 Feb 25.

This single-center retrospective study evaluated the outcomes of 110 patients with Crohn’s disease who underwent dose intensification, thus shortening the interval between 90-mg doses of ustekinumab from every 8 weeks to every 4 weeks. Clinicians at a tertiary-care center shortened the dosing interval of ustekinumab in patients with active Crohn’s disease based upon clinical symptoms, elevated biologic markers, and/or endoscopy. Serum trough concentrations of ustekinumab and anti-ustekinumab antibodies were not routinely measured and, therefore, were not taken into consideration in the analysis (according to personal communication with Dr. Pekow, one of the study authors). 

The median time to dose escalation was 7.5 months after therapy initiation (interquartile range [IQR], 4.2-13.2). Patients had clinically, biologically, and/or endoscopically active disease based upon a Harvey Bradshaw Index (HBI) score >4, a C-reactive protein (CRP) level ≥5 mg/dl, fecal calprotectin >250 ug/g, or ulceration on ileocolonoscopy. After the dose interval was shortened, 28% of the patients achieved clinical remission (an HBI score ≤4), 22% had normalized CRP (<5 mg/dl), 50% had reduced fecal calprotectin, and 36% achieved endoscopic remission at a median follow-up of 3 months (IQR, 1.7-5.4). Among patients on steroids at the time of dose escalation, 38% were weaned off steroids within 6 months. Among patients with perianal disease, 45% reported resolution of fistulas within 6 months. No serious adverse events were reported, and only one patient developed a rash during the intensified therapy.

COMMENT
This is the first paper to report real-world outcomes in patients with Crohn’s disease after dose escalation of 90-mg ustekinumab to a shortened interval of 4 weeks. Notably, about one-third of patients not on clinical, biological, or endoscopic remission with the 8-week dosing interval achieved remission on the 4-week dosing interval approved by the FDA. Before stopping ustekinumab in primary and secondary nonresponders, it is worthwhile to try shortening the dosing interval:

Monika Fischer, MD, FASGE

CITATION(S )

Ollech JE, Normatov I, Peleg N, et al. Effectiveness of ustekinumab dose escalation in patients with Crohn’s disease. Clin Gastroenterol Hepatol 2020 Feb 25. (Epub ahead of print) (https://doi.org/10.1016/j.cgh.2020.02.035)

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