Real-world clinical effectiveness and safety of vedolizumab and anti-tumor necrosis factor alpha treatment in ulcerative colitis and Crohn\u2019s disease patients: a German retrospective chart review

Ulf Helwig,Heinz Hartmann,Alina Brandes,Stefan Schubert,Michael Mross,Christian Kempf,Jana Knop,Sarah Campbell-Hill,Dara Stein,Robert Ehehalt

doi:10.1186/s12876-020-01332-w

Abstract

BackgroundReal-world comparisons of biologic treatment outcomes for ulcerative colitis (UC) or Crohn’s disease (CD) patients are limited. We sought to evaluate the real-world effectiveness of vedolizumab (VDZ) and anti-tumor necrosis factor alpha (anti-TNFα) in UC and CD patients in Germany.MethodsA retrospective chart review (15 sites) investigated UC and CD patients who were biologic-treatment naïve (biologic-naïve) or had received no more than one prior anti-TNFα before initiating treatment with VDZ or anti-TNFα between 15 July 2014 and 20 October 2015. Kaplan-Meier analyses assessed time to first chart-documented clinical remission (CR) and symptom resolution (UC: rectal bleeding [RB], stool frequency [SF]; CD: abdominal pain [AP], liquid stools [LS]) and outcome duration.ResultsA total of 133 UC (76 VDZ; 57 anti-TNFα) and 174 CD (69 VDZ; 105 anti-TNFα) patients were included. By Week 26, estimated cumulative rates of patients achieving CR or symptom resolution with VDZ vs anti-TNFα treatment were for UC: CR, 53.7% vs 31.7%; RB, 66.8% vs 55.8%; and SF, 59.8% vs 50.7%, respectively; and for CD: CR, 14.4% vs 32.8%; AP, 62.5% vs 56.0%; and LS, 29.9% vs 50.3%, respectively. Outcomes were sustained similarly between treatments, except RB (VDZ vs anti-TNFα: median 38.1 vs 15.1 weeks, P = 0.03). Treatment-related adverse events occurred in 5.3% vs 7.0% (UC) and 8.7% vs 19.0% (CD) of VDZ vs anti-TNFα patients, respectively.ConclusionsAlthough there were differences in CR, symptom resolution, and safety profiles, real-world data support both VDZ and anti-TNFα as effective treatment options in UC and CD.

Highlights

Real-world comparisons of biologic treatment outcomes for ulcerative colitis (UC) or Crohn’s disease (CD) patients are limited
Ulcerative colitis (UC) and Crohn’s disease (CD) both originate from dysregulation of the immune system and are the most common types of inflammatory bowel disease (IBD), with prevalence increasing in Germany and worldwide [1, 2]
UC patients treated with vedolizumab or anti-TNFα were 47% vs 58% female, median patient age was 39.5 vs 34.0 years, and median disease duration was 6.1 vs 4.7 years

Summary

Introduction

Real-world comparisons of biologic treatment outcomes for ulcerative colitis (UC) or Crohn’s disease (CD) patients are limited. Recent estimates of prevalence in Germany were 412 (95% confidence interval [CI], 389– 436) cases of UC and 322 (95% CI, 302–346) cases of CD per 100,000 persons [2] Both UC and CD are chronic diseases that often require life-long treatment and frequent hospitalization, resulting in reduced patient quality of life and substantial healthcare resource utilization [3, 4]. Patients with moderately or severely active IBD who have had an inadequate disease response, lost response, or were intolerant to a conventional treatment such as a corticosteroid, aminosalicylate, and/or immunomodulatory drug may be treated with a biologic agent, such as a tumor necrosis factor alpha (anti-TNFα) antagonist (adalimumab, infliximab, or golimumab [approved in Europe for UC only]), ustekinumab, vedolizumab, or with the oral small molecule janus kinase (JAK) inhibitor tofacitinib (approved for UC only). High treatment failure rates indicate a need for other first- and second-line biologic treatment options to improve the management and outcomes of patients with UC or CD [8,9,10,11,12]

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