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Biologics Dose Escalation for the Treatment of Inflammatory Bowel Disease: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Last updated: August 28, 2018
Project Number: RC1005-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of higher or more frequent versus standard dosing of biologics for the treatment of inflammatory bowel disease?
  2. What is the clinical effectiveness of higher or more frequent than standard dosing versus switching biologics for the treatment of inflammatory bowel disease?
  3. What is the cost-effectiveness of higher or more frequent versus standard dosing of biologics for the treatment of inflammatory bowel disease?
  4. What is the cost-effectiveness of higher or more frequent than standard dosing versus switching of biologics for the treatment of inflammatory bowel disease?
  5. What are the evidence-based guidelines regarding higher or more frequent than standard dosing of biologics for the treatment of inflammatory bowel disease?

Key Message

There is limited evidence to comparing the effectiveness of different doses of the following biologics in patients with inflammatory bowel disease (IBD): vedolizumab, adalimumab, infliximab. There were no studies on golimumab or ustekinumab identified. The sample sizes of the primary studies ranged from 33 to 778. Weekly and biweekly adalimumab doses were associated with similar clinical responses and frequencies of serious infectious adverse events. Biweekly adalimumab 40 mg or 80 mg was associated with comparable trough concentrations. The sample sizes for the trials on vedolizumab were not enough to compare the effectiveness of high and standard doses. For infliximab, dose intensification based on a multiple-criteria algorithm was similarly effective as symptom-based dose intensification in a RCT. Two of the three retrospective cohort studies provided conflicting evidence regarding the needs for colectomy. One study found that an accelerated infliximab induction strategy reduced the need for early colectomy, while another discovered that an accelerated infliximab doses after initial standard infusion was associated with higher colectomy rates for patients with acute ulcerative colitis. In the third retrospective cohort study by Nagata et al., doubling the infliximab dose and shortening the intervals of infliximab infusion were similarly effective to achieve clinical response, compared to switching to adalimumab in the short or long run. The included guideline indicated that for those who are considered secondary non-responders, dose escalation or switching may be appropriate. No relevant cost-effectiveness studies regarding higher or more frequent versus standard dosing or switching of biologics for the treatment of inflammatory bowel disease.