Introduction Vedolizumab is recommended by the National Institute for Health and Care Excellence (NICE) as a treatment for adults with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn’s disease (CD) where tumour necrosis factor (TNF) alpha inhibition is either unsuitable or has been ineffective. As the drug was approved by NICE in 2015 there is currently limited available real world data on its clinical effectiveness. We report outcomes of vedolizumab use in a group of 23 patients at a single UK centre.
Method Diagnosis is recorded in the table below with UC patients subcategorised according to disease location.
30.4% of patients (n=7/23) were documented to have already received at least 1 biologic agent prior to starting vedolizumab and 13% of patients (n=3/23) had received 2 or more biological agents prior to starting vedolizumab. Patients received infusions of 300 mg vedolizumab at weeks 0, 2, 6, then at 8 weekly intervals thereafter. Patient reported outcomes were recorded at each visit for drug infusion using the Modified Mayo Score (MMS) for patients with UC and the Harvey Bradshaw index (HBI) for patients with CD. Biochemical markers of disease activity were measured at each visit and a faecal calprotectin measurement at 16 weeks post treatment commencement. A clinical review at 16 weeks and at 1 year was also recorded.
Results A reduction in MMS or HBI was noted in 43.5% of all patients (n=10/23) at 14 weeks. A reduction of ≥50% was noted in 38.1% of UC patients (n=8/21) at 14 weeks. At 30 weeks, 60% had a MMS of 0 (n=6/10). MMS is documented in 3 patients at 52 weeks. Of these, 2 showed a reduction from baseline of more than 60%. 1 patient did not have a recorded baseline MMS hence comparison was not possible. A reduction in HBI was recorded in both patients with CD at 14 weeks. This was a reduction of 16.7% in one patient and 82.4% in the other. All faecal calprotectin measurements done prior to commencing vedolizumab were elevated. 21.7% of patients (n=5/23) had a faecal calprotectin within the normal range 14 weeks after commencing treatment. Of the 5 patients who have completed 1 year of treatment, 40% are in clinical remission and continue on vedolizumab infusions every 8 weeks. Drug administration was recorded on 139 occasions. Adverse reaction was noted on a single occasion (0.01%) which was documented as “arm felt heavy post infusion”.
Conclusion Patient reported outcomes showed a combined response rate of 43.5% (n=10/23) at 14 weeks in CD and UC. This is comparable to published trial data.
Disclosure of Interest None Declared
- Crohn’s disease
- Ulcerative colitis