Background: Two groups of biological therapies are licensed and approved by NICE for the management of moderate to severe UC in the UK. These are the anti-TNF drugs, Infliximab, Adalimumab and Golimumab & the α4β7 anti-integrin Vedolizumab. There are no published head-to-head RCTs comparing the efficacy and safety of these two groups of drugs for UC. We aim to compare the outcomes for all patients treated with biological therapy for UC in our unit of 3, 000 IBD patients.
Methods: Anti-TNF or VDZ has been used routinely for UC maintenance therapy in Leeds since Oct 2015. We use biosimilar infliximab as our first-line anti-TNF agent with VDZ reserved for ant-TNF failures or contraindications. Acute severe colitis cases were excluded. We prospectively collected data on demographics, CRP, calprotectin & clinical outcomes over a 9 month period. Response and remission at 3 months were defined according to Mayo scores or physician global assessment (PGA) and compared using the Chi-squared test.
Results: A total of 36 (20 female) patients received biological therapy for UC in this period (17IFX, 6 ADA, 13 VDZ). Results for IFX:ADA:VDZ respectively are; Mean age 38 (18–68), 30 (25–46) & 41 (19–77), disease duration pre-treatment (months) 92.8, 23.4, 54. Mean weight 74kg, 80kg, 81kg. Mayo scores at baseline were 6.4, 7.3, 7 or with endoscopy sub-scores 8.5 (n=14), 9.5 (n=2) & 9 (n=8). Mean steroid dose at baseline: 10.5mg, 1.6mg & 15mg. Thiopurines at baseline 59%, 33% and 62%. 17/17 (100%) IFX patients were given the drug first line as opposed to 4/6 (67%) of ADA and 2/13 (15%) VDZ pts. VDZ was used first-line in one case of MS & one of possible latent TB. By 3 months of IFX therapy 1 dose escalated, 3 switched to ADA due to low drug levels with high antibodies and 1 rash and 1 infusion reaction necessitated IFX withdrawal. 50% of Humira patients dose escalated by 3 months. There were 4 colectomies in the VDZ group, all had previously failed one or more anti-TNF therapy. There was no significant difference in response (p=0.17) and remission (p=0.62) rates between infliximab and VDZ.
Conclusions: Anti-TNF and VDZ therapies are safe & effective in the management of UC. Whilst the numbers of adalimumab treated patients is small 50% of patients dose escalated which should be noted when considering the overall relative costs of these therapies. VDZ response and remission rates of 69% and 38% are encouraging in this largely anti-TNF failure cohort but more data on cost-effectiveness of anti-TNF versus VDZ first-line are required.