Objective To establish the relationship between trough vedolizumab levels and outcomes during maintenance therapy.
Design Cross-sectional service evaluation was performed on patients with inflammatory bowel disease (IBD) receiving maintenance vedolizumab therapy (minimum of 12 weeks following induction). Prior to infusion, data on clinical activity (Harvey-Bradshaw Index or partial Mayo score), trough C-reactive protein (CRP)/vedolizumab levels and faecal calprotectin were collected. Endoscopic data (±8 weeks from vedolizumab level testing) were obtained by review of medical records. Vedolizumab levels were processed using the Immundiagnostik monitor ELISA.
Setting The Edinburgh IBD Unit, Western General Hospital (tertiary IBD referral centre).
Patients Seventy-three patients (30 ulcerative colitis and 43 Crohn’s disease) were identified who fulfilled inclusion criteria and had vedolizumab levels matched with clinical activity scores, CRP and faecal calprotectin. Of these, 40 patients also had matched endoscopic data.
Main outcome measures The association of trough vedolizumab levels with clinical remission (Harvey-Bradshaw Index <5 or partial Mayo <2), biologic remission (faecal calprotectin <250 µg/g+CRP <5 mg/L) and endoscopic remission (Mayo score 0/no inflammation and ulceration on colonoscopy).
Results The median trough vedolizumab levels were similar between patients in and not in clinical remission (10.6 vs 9.9 µg/mL, p=0.54); biologic remission (10.6 vs 9.8 µg/mL, p=0.35) and endoscopic remission (8.1 vs 10.2 µg/mL, p=0.21). Quartile analysis revealed no significant increase in the proportion of patients in clinical remission, biologic remission or endoscopic remission with increasing trough vedolizumab levels (p<0.05).
Conclusions In this cohort, trough vedolizumab levels were not associated with clinical, biological or endoscopic outcomes during maintenance therapy.
- therapeutic drug monitoring
- ulcerative colitis
- crohn’s disease
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Contributors NP contributed to the study design, data collection, analysis and writing of manuscript. PWJ, CSC, ML, LMM and RJP contributed to the data collection and critically reviewed the manuscript. IDA, GRJ and CWL contributed to the study design, analysis and critically reviewed the manuscript. All authors approved the final manuscript.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests PWJ, CSC, ML, RJP and GRJ have no personal interests to declare. NP has received consultancy fees from Takeda, speaker fees and/or travel support from Abbvie, Takeda, Norgine. LMM has received travel support from Janssen. IDA has received consultancy fees from Vifor and travel support from Shire. CWL has received research support from Abbvie and Shire, consultancy fees from Abbvie, Pfizer, Dr Falk, Hospira, MSD, Pharmacosmos, Takeda and Vifor, speaker fees and/or travel support from Abbvie, Pfizer, Dr Falk, Ferring, Hospira, MSD, Shire, Takeda and Warner-Chilcott.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.