Background Despite the proven efficacy of vedolizumab (VDZ) for ulcerative colitis (UC) and Crohn’s disease (CD), suboptimal response is commonly encountered. However, data regarding the effectiveness of dose intensification (by interval shortening) to achieve response are limited.
Objectives We evaluated the effectiveness of dose intensification at achieving response in patients with a previously suboptimal response to VDZ. Additionally, we aimed to identify predictors of response to this strategy.
Methods We performed a retrospective cohort study of patients who underwent VDZ dose intensification for suboptimal response. Clinical disease activity was evaluated at the point of dose intensification (baseline) and at weeks 12 and 24. Response was defined as Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) reduction of ≥3, and remission as HBI <5 or SCCAI <3.
Results A total of 36 patients received dose intensification to 4-weekly infusions: 18 CD, 14 UC and 4 inflammatory bowel disease-unclassified (analysed in the UC group). Median SCCAI scores fell from 6 (range 0–11) at baseline to 4 (0–6, p=0.008) at week 24, while HBI scores did not change significantly (4 (0–27) and 3 (0–8), p=0.092). Overall median C reactive protein (CRP) fell from 6 mg/L (1–23) to 2 mg/L (1–17, p=0.011). Of 20 patients with clinically active disease at baseline, 10 (50%) responded, of whom 4 (20%) achieved remission at week 24. Univariate analysis demonstrated low baseline CRP (p=0.045) and response at week 12 (0.020) were associated with week 24 response.
Conclusions Our findings demonstrate VDZ dose intensification to be effective at achieving clinical response in half of patients. Low baseline CRP and response at week 12 are potential predictors of week 24 response.
- dose intensification
- ulcerative colitis
- crohn’s disease
- inflammatory bowel disease
Statistics from Altmetric.com
MAS and SB are joint first authors.
Contributors MAS, SB, MSM and PMI were responsible for the original concept and planning of the study. MAS, SB, MSM, SH, AGT and GC were responsible for data collection and analysis. MAS, SB and MSM drafted the manuscript, which IK, SR, JM, SHCA, JS and PMI critically reviewed and revised.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests MAS: served as a speaker, a consultant and/or an advisory board member for Janssen, Takeda, MSD and Falk. MSM: served as a speaker for Takeda. SH: served as a speaker for Janssen. PMI: served as a speaker, a consultant and/or an advisory board member for AbbVie, Warner Chilcott, Ferring, Falk Pharma, Takeda, MSD, Johnson & Johnson, Shire, Vifor Pharma, Pharmacosmos, Topivert, Genentech, Hospira and Samsung Bioepis, and has received research funding from MSD and Takeda.
Patient consent for publication Not required.
Ethics approval The Health Research Authority (HRA) does not consider postmarketing surveillance and research, and therefore recommend that NHS Research Ethics Committee (REC) approval was not necessary for this study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.