Abstract

Effectiveness of Ustekinumab Dose Escalation in Patients with Crohn’s Disease

Ollech JE1, Normatov I2, Peleg N3, Wang J2, Patel SA2, Rai V2, Yi Y2, Singer J2, Dalal SR2, Sakuraba A2, Cohen RD2, Rubin DT2, Pekow J2. Clin Gastroenterol Hepatol. 2020 Feb 25. pii: S1542-3565(20)30205-6. doi: 10.1016/j.cgh.2020.02.035. [Epub ahead of print]

 
     

Author information

1 Inflammatory Bowel Disease Center, The University of Chicago Medicine, Chicago, IL, USA; Inflammatory Bowel DiseaseCenter, Rabin Medical Center, Petah Tikva, Israel. Tel Aviv University, Sackler Faculty of Medicine, Tel Aviv, Israel. Electronic address: kollech@gmail.com.

2 Inflammatory Bowel Disease Center, The University of Chicago Medicine, Chicago, IL, USA.

3 Inflammatory Bowel Disease Center, Rabin Medical Center, Petah Tikva, Israel. Tel Aviv University, Sackler Faculty of Medicine, Tel Aviv, Israel.

Abstract

BACKGROUND & AIMS: A subset of patients with Crohn's disease (CD) do not respond to ustekinumab at the standard dose of 90 mg every 8 weeks. Little is known about the efficacy of shortening the interval between doses.

METHODS: We performed a retrospective study to determine the effectiveness of ustekinumab dose interval shortening, collecting data from 506 patients with CD who received subcutaneous ustekinumab 90 mg every 8 weeks at a single center. We obtained data from 110 patients who initially received subcutaneous ustekinumab 90 mg every 8 weeks and then had their interval shortened to every 4 weeks. Harvey Bradshaw Index (HBI) scores before and after the dose interval shortening was available for 78 patients in the cohort (71%), levels of C-reactive protein (CRP) for 60 patients (55%), and levels of fecal calprotectin for 8 patients (7%).

RESULTS: Following dose interval shortening, the patients' median HBI decreased from 4.5 to 3 (P=.002), the median level of CRP decreased from 8 mg/l to 3 mg/l (P=.031), and median level of fecal calprotectin decreased from 378 μg/g to 157 μg/g (P=.57). Among patients who had an HBI >4, a level of CRP ≥5mg/dl, a level of fecal calprotectin >250ug/g, or endoscopic evidence for disease activity before dose interval shortening, after the dose interval was shortened, 28% achieved clinical remission (an HBI score ≤4), 22% had a normal level of CRP (<5 mg/dl), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission.

CONCLUSIONS: Shortening the ustekinumab 90 mg dose interval to 4 weeks for patients with CD who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe.

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