Comparative effectiveness of adalimumab versus infliximab in children with Crohn’s disease: real-world data from the prospective PIBD-SETQuality inception cohort study

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ID: 319680
2026
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Abstract
Summary Background Infliximab and adalimumab are effective anti-tumor necrosis factor (anti-TNF) therapies for the treatment of pediatric Crohn’s disease (CD). The aim of this study was to compare the effectiveness of infliximab and adalimumab in a real-world cohort of children with CD. Methods Data from biological-naïve children with luminal CD (age 3-18 years) who commenced anti-TNF and completed at least one year of follow-up were collected from the prospective multicenter observational PIBD-SETQuality study. The primary outcome was steroid-free clinical remission (SFCR), defined as clinical remission [wPCDAI <12.5] without systemic steroids or luminal surgery at 1 year. The relative risk (RR) of SFCR was calculated using standardization, correcting for the following baseline covariates: age, upfront anti-TNF, CRP, ESR, albumin, leukocytes, disease behavior, wPCDAI, perianal disease, and concomitant immunomodulator use. Secondary outcomes included the durability of anti-TNF treatment without luminal surgery. Results Between January 1, 2017, and June 14, 2024, 178 patients with anti-TNF were included (infliximab: n = 121 [68%], adalimumab: n = 57 [32%]). At 12 months, 34/56 (61%) patients treated with adalimumab and 66/120 (55%) patients treated with infliximab had reached SFCR. The RR of SFCR at 1 year with adalimumab compared to infliximab was 1.25 [95% CI 0.94—1.66], p = 0.13. Adalimumab was associated with a significant lower adjusted Hazard Ratio (aHR) of treatment discontinuation than infliximab in patients with a concomitant immunomodulator (aHR 0.17 [95% CI 0.04—0.75], p = 0.020), adjusted for upfront anti-TNF. Conclusions In this prospective cohort of children with CD, adalimumab and infliximab showed comparable clinical effectiveness one year after the start of anti-TNF treatment.
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Authors Stephanie A Vuijk, Renz C W Klomberg, Eva Katgert, Margreet M S Wessels, Erasmo Miele, Fiona Cameron, Ivan Milovanovich, Rafeeq Muhammed, David Devadason, James Hart, Dimitris Rizopoulos, Nicholas M. Croft, Lissy de Ridder, Dan Turner, Gili Focht, N M Croft, Lissy de Ridder, Gigi Veereman, Sibylle Koletzko, Annecarin Brückner, Richard Russell, Dror Weiner, Anne Griffiths, Marina Aloi, Thomas Walters, Frank Ruemmele
Journal Crohn s & Colitis 360
Year 2026
DOI
10.1093/crocol/otag069
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