Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn's Disease patients: A retrospective analysis using German claims data

Evi Zhuleku; Beatriz Antolin-Fontes; Andras Borsi; Riikka Nissinen; Ivana Bravatà; Jennifer Norma Barthelmes; Manuela Le Bars; Jennifer Lee; Alun Passey; Ulf Maywald; Barthold Deiters; Bernd Bokemeyer; Thomas Wilke; Marco Ghiani

doi:10.1177/17562848221130554

Real-world outcomes associated with switching to anti-TNFs versus other biologics in Crohn's Disease patients: A retrospective analysis using German claims data

Therap Adv Gastroenterol. 2022 Nov 4:15:17562848221130554. doi: 10.1177/17562848221130554. eCollection 2022.

Authors

Affiliations

¹ Cytel Inc., Potsdamer Str. 58, Berlin 10785, Germany.
² Cytel Inc., Berlin, Germany.
³ Janssen-Cilag Ltd., High Wycombe, UK.
⁴ Janssen-Cilag Oy, Espoo, Finland.
⁵ Janssen-Cilag S.p.A., Milan, Italy.
⁶ Janssen-Cilag GmbH, Neuss, Germany.
⁷ Janssen-Cilag SARL, Issy-les-Moulineaux, France.
⁸ AOK PLUS, Dresden, Germany.
⁹ GWQ ServicePlus AG, Düsseldorf, Germany.
¹⁰ Interdisciplinary Crohn Colitis Centre Minden, Minden, Germany.
¹¹ IPAM - Institut für Pharmakoökonomie und Arzneimittellogistik e.V., Wismar, Germany.

Abstract

Background: The positioning of new biologic agents for the treatment of Crohn's disease (CD) following failure of initial anti-tumor necrosis factor (anti-TNF) therapy remains a challenge in the real world.

Objectives: This study aims to investigate the real-world outcomes associated with the sequential use of biologics in CD patients that newly initiate anti-TNFs, specifically comparing those that switch to another anti-TNF versus biologics with other modes of action.

Design: Retrospective cohort study.

Methods: We identified CD patients who newly began anti-TNF therapy between 1 October 2014 and 31 December 2018 using two German claims databases. Patients were classified as within-class switchers (WCS) if they switched to another anti-TNF or outside-class switchers (OCS) if they switched to vedolizumab (VDZ) or ustekinumab (UST). To compare WCS and OCS, baseline covariates were adjusted through inverse probability of treatment weighting (IPTW), and time-to-event analyses were performed using Cox Proportional Hazard regressions. Results from both databases were meta-analyzed using an inverse variance model.

Results: Overall, 376 prevalent adult CD patients who initiated anti-TNFs and switched to another biologic were identified. After IPTW, there were 152 and 177 patients in the WCS and OCS group, respectively. WCS were more likely to receive prolonged corticosteroid therapy [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.17-2.27, p = 0.004], switch a second time to a different biologic (HR: 2.44, 95% CI: 1.63-3.66, p < 0.001), and discontinue treatment (HR: 1.71, 95% CI: 1.25-2.34, p = 0.001) than OCS.

Conclusion: This study suggests that CD patients exhibit more favorable outcomes when switching outside the anti-TNF class to VDZ or UST after initial anti-TNF failure than switching to a second anti-TNF. With loss of response to anti-TNFs as a concern in the real world, comparative evidence from claims data assessing sequential use of biologics can help optimize treatment algorithms of patients after anti-TNF failure.

Keywords: Crohn’s disease; anti-tumor necrosis therapy; real-world evidence; ustekinumab; vedolizumab.