Comparative real-world outcomes between ustekinumab, infliximab, and adalimumab in bio-naïve and bio-experienced Crohn's disease patients: a retrospective multicenter study

• Published in: BMC gastroenterology Vol. 24; no. 1; pp. 306 - 11
• Main Authors: Na, Ji Eun, Park, Yong Eun, Park, Jongha, Kim, Tae-Oh, Lee, Jong Hoon, Park, Su Bum, Kim, Soyoung, Lee, Seung Bum
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 11-09-2024; BioMed Central; BMC
• Subjects: Adalimumab; Adalimumab - therapeutic use; Adult; Age; Bio-naïve and bio-experienced patients; Biological products; Clinical outcomes; Crohn Disease - drug therapy; Crohn Disease - surgery; Crohn's disease; Crohns disease; Drug dosages; Drug therapy; Efficacy and prognosis; Female; Gastrointestinal Agents - therapeutic use; Hospitalization; Hospitalization - statistics & numerical data; Humans; Immunomodulators; Immunotherapy; Induction therapy; Infliximab; Infliximab - therapeutic use; Insurance policies; Intestine; Male; Medical records; Middle Aged; Moderate to severe Crohn’s disease; Monoclonal antibodies; Patient outcomes; Patients; Remission; Remission (Medicine); Remission Induction; Response rates; Retrospective Studies; Statistical analysis; Treatment Outcome; Tumor Necrosis Factor Inhibitors - therapeutic use; Tumor necrosis factor-TNF; Tumor necrosis factor-α; Ustekinumab - therapeutic use; Ustekinumab and anti-tumor necrosis factor agents; Young Adult; South Korea; Moderate to severe Crohn’s disease; Ustekinumab and anti-tumor necrosis factor agents; Bio-naïve and bio-experienced patients; Efficacy and prognosis
• ISSN: 1471-230X; 1471-230X
• DOI: 10.1186/s12876-024-03403-8

Numerous studies have compared the efficacy of ustekinumab (UST) and anti-TNF agents [infliximab (IFX) or adalimumab(ADA)] in moderate to severe Crohn's disease (CD) patients. This study aims to compare the efficacy of UST, IFX, and ADA while differentiating between bio-naïve and bio-experienced patients, which is an underexplored aspect, particularly in Asia.
We conducted a retrospective multi-center study from 2012 to 2023, categorizing patients into bio-naïve and bio-experienced groups. We evaluated clinical remission rates after induction therapy and clinical outcomes, including CD-related hospitalization, intestinal resection, and drug discontinuation during maintenance therapy.
Among the 214 bio-naïve CD patients, 60 received UST, 108 received IFX, and 46 received ADA. After 1:1 propensity score matching between UST and anti-TNF agents groups, 59 patients were analyzed in each group (45 in the IFX group and 14 in the ADA group). We found no significant differences in clinical remission rates (P = 0.071), CD-related hospitalization (P = 0.800), intestinal resection (P = 0.390), or drug discontinuation (P = 0.052) between the UST, IFX, and ADA groups in bio-naïve CD patients. In bio-experienced CD patients, with 35 in the UST group and 13 in the anti-TNF agents group, the UST group showed a lower risk of drug discontinuation (P = 0.004) than the anti-TNF agents group.
This study suggests that UST, IFX, and ADA are equally effective in bio-naïve CD patients, while in bio-experienced patients, mostly with previous exposure to anti-TNF agents, UST may offer superior drug durability.