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. 2023 May 1;76(5):566-575.
doi: 10.1097/MPG.0000000000003734. Epub 2023 Feb 19.

Use, Durability, and Risks for Discontinuation of Initial and Subsequent Biologics in a Large Pediatric-Onset IBD Cohort

Jess L Kaplan  1 , Chunyan Liu  2 , Eileen C King  2   3 , Julie A Bass  4 , Ashish S Patel  5 , Jeanne Tung  6 , Shiran Chen  2 , Trevor Lissoos  7 , Ninfa Candela  7 , Shehzad Saeed  8 , Richard B Colletti  9 ; for the ImproveCareNow Network
Collaborators, Affiliations

Use, Durability, and Risks for Discontinuation of Initial and Subsequent Biologics in a Large Pediatric-Onset IBD Cohort

Jess L Kaplan et al. J Pediatr Gastroenterol Nutr. .

Abstract

Background: Biologic medications are recommended for treatment of moderately-to-severely active Crohn disease (CD) or ulcerative colitis (UC) in children. However, many patients require sequential biologic treatment because of nonresponse or loss of response to the initial biologic.

Methods: We analyzed pediatric inflammatory bowel disease (IBD) data from the ImproveCareNow Network registry between May 2006 and September 2016, including time to biologic initiation, choice of first subsequent biologics, biologic durability, and reasons for discontinuation.

Results: Of 17,649 patients with IBD [CD: 12,410 (70%); UC: 5239 (30%)], 7585 (43%) were treated with a biologic agent before age 18 (CD: 50%; UC: 25%). Biologic treatment was more likely for CD than UC (odds ratio, 3.0; 95% CI: 2.8-3.2; P < 0.0001). First biologic agents for all patients were anti-tumor necrosis factor agents (88% infliximab, 12% adalimumab). Probability of remaining on the first biologic was significantly higher in CD than UC ( P < 0.0001). First biologics were discontinued because of loss of response (39%), intolerance (23%), and nonresponse (19%). In univariate analysis, factors associated with discontinuation of first and/or second biologics in CD include colonic-only disease, corticosteroid use, upper gastrointestinal tract involvement, and clinical and biochemical markers of severe disease. Biologic durability improved with later induction date.

Conclusions: Treatment with biologic medications is common in pediatric IBD. Patients with CD are more likely to receive biologics, receive biologics earlier in disease course, and remain on the first biologic longer than patients with UC. Multiple factors may predict biologic durability in children with IBD.

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Conflict of interest statement

R.B.C. received financial support for research in Janssen Biotech and received consultancy fees from Janssen Biotech and Janssen Research and Development. A.S.P. received lecture fee(s) from Janssen Biotech, AbbVie, and Abbott Nutrition and received consultancy fees from QOL. N.C. is an employee of Takeda Pharmaceuticals U.S.A., Inc., and owns stock or stock options. T.L. was an employee of Takeda Pharmaceuticals U.S.A., Inc., at the time the study was conducted. S.S. is in the Speaker’s Bureau for AbbVie, Inc. The remaining authors report no conflicts of interest.

Figures

None
Graphical abstract
FIGURE 1.
FIGURE 1.
Kaplan-Meier analysis of continuation of first biologic agent over time in the Biologic Inception Cohort by IBD diagnosis (CD, n = 772; UC, n = 206); 51 patients were excluded because of missing time or discontinuation status. CD = Crohn disease; IBD = inflammatory bowel disease; UC = ulcerative colitis.
FIGURE 2.
FIGURE 2.
Kaplan-Meier curves of discontinuation of first biologic by 18 months in 2 induction periods by diagnosis. Left: IBD cohort (log-rank test P = 0.03); middle: CD cohort (log-rank test P = 0.016); right: UC cohort (log-rank test P = 0.25). CD = Crohn disease; IBD = inflammatory bowel disease; UC = ulcerative colitis.
See this image and copyright information in PMC

References

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