Comparative effectiveness of antitumour necrosis factor agents and vedolizumab in ulcerative colitis

Abstract

Introduction Antitumour necrosis factor (TNF) agents and vedolizumab are used to treat ulcerative colitis (UC) but the response is variable and there is little data on comparative effectiveness. Apart from previous exposure to anti-TNF agents, predictors of response have not been identified. We aimed to (i) compare the efficacy of anti-TNF agents and vedolizumab in UC and (ii) investigate the utility of clinical and biochemical parameters in predicting response. Patients and methods Patients commencing any biological therapy for ambulant UC were included. Disease activity was monitored serially with the Simple Clinical Colitis Activity Index for up to 12 months. We compared the efficacy of anti-TNF agents and vedolizumab for induction and maintenance of response and remission on an intention-to-treat basis. We examined the utility of faecal calprotectin (FC) and early normalization of FC to predict response. Results Ninety-seven patients commencing anti-TNF and 42 commencing vedolizumab therapy were included. Vedolizumab-treated patients had significantly greater previous anti-TNF therapy exposure and a lower baseline FC. Response, remission and steroid-free remission rates were comparable between both groups at 6 weeks, 6 and 12 months. Clinical remission but not steroid-free remission at 12 months was higher in the vedolizumab group. There was a significant reduction in the Simple Clinical Colitis Activity Index and FC at 6 weeks, 6 and 12 months compared with baseline in both groups. Baseline FC and early normalization did not predict response at 6 and 12 months. Conclusion The efficacy of anti-TNF and vedolizumab in UC appear comparable. We could not identify any predictors of response and remission.

Primary Failure to an Anti-TNF Agent in Inflammatory Bowel Disease: Switch (to a Second Anti-TNF Agent) or Swap (for Another Mechanism of Action)?

“…Some studies in IBD patients have shown that previous anti-TNF therapy is a risk factor for failure of treatment with vedolizumab [13,14,[50][51][52][53][54][55][56], regardless of the reason for anti-TNF discontinuation; conversely others have shown that the response to vedolizumab is independent of previous anti-TNF failure [57][58][59][60][61][62][63]. Nevertheless, it should be noted that, to date, most of the patients who received vedolizumab treatment, both in randomised controlled trials and in clinical practice, were anti-TNF experienced [64].…”

Drug survival of anti‐TNF agents compared with vedolizumab as a second‐line biological treatment in inflammatory bowel disease: results from nationwide Swedish registers

“…Even though numerous studies have demonstrated that biological agents can reverse the inflammation in IBD, a recent large retrospective real‐world study from the United States shows that more than half of patients with IBD discontinue treatment with their initial biological within the first 12 months 44 . Information on which biological agent to use as second‐line treatment after initial anti‐TNF failure is sparse and previous observational studies comparing the effectiveness of a second anti‐TNF agent vs vedolizumab are limited by small sample size or study design 29‐34 …”

“…In addition, anti‐TNF treatment was restricted to adalimumab and most patients treated in clinical practice would not have been eligible for the VARSITY trial, where inclusion was restricted to patients of certain ages, degrees of disease activity, comorbidity, prior and concurrent medications. Real‐world studies comparing the effectiveness of an anti‐TNF agent vs vedolizumab show conflicting data and some include a mixture of patients with different anti‐TNF exposure, making the results difficult to interpret 29‐34 …”

Factors influencing the outcome of vedolizumab treatment: Real‐life data with objective outcome measurements

“…VDZ was superior to adalimumab with respect to achievement of clinical remission and endoscopic improvement but not corticosteroid‐free clinical remission 6 . However, another study indicated a comparable efficacy of VDZ and anti‐TNF agents among UC patients 7 . Also, compared to anti‐TNF agents, VDZ has a rather limited effect on extraintestinal manifestations of IBD 8 .…”

“…6 However, another study indicated a comparable efficacy of VDZ and anti-TNF agents among UC patients. 7 Also, compared to anti-TNF agents, VDZ has a rather limited effect on extraintestinal manifestations of IBD. 8 In summary, it remains unclear if certain classes of medications would be more favourable compared to others as first-line therapy, since reliable predictive biomarkers are still lacking.…”