Gabrusskaya T, Ulanova N, Shilova E, Volkova N, Kilina S, Kornienko E, Kostik M. Efficacy and safety of dual-targeted therapy in children with inflammatory bowel disease: Retrospective cohort study. World J Clin Pediatr 2026; 15(1): 111093 [DOI: 10.5409/wjcp.v15.i1.111093]
Corresponding Author of This Article
Mikhail Kostik, MD, PhD, Professor, Hospital Pediatry, Saint-Petersburg State Pediatric Medical University, Lytovskaya 2, Saint Petersburg 194100, Sankt-Peterburg, Russia. kost-mikhail@yandex.ru
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Pediatrics
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Retrospective Cohort Study
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Mar 9, 2026 (publication date) through Mar 12, 2026
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World Journal of Clinical Pediatrics
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2219-2808
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Gabrusskaya T, Ulanova N, Shilova E, Volkova N, Kilina S, Kornienko E, Kostik M. Efficacy and safety of dual-targeted therapy in children with inflammatory bowel disease: Retrospective cohort study. World J Clin Pediatr 2026; 15(1): 111093 [DOI: 10.5409/wjcp.v15.i1.111093]
World J Clin Pediatr. Mar 9, 2026; 15(1): 111093 Published online Mar 9, 2026. doi: 10.5409/wjcp.v15.i1.111093
Efficacy and safety of dual-targeted therapy in children with inflammatory bowel disease: Retrospective cohort study
Tatiana Gabrusskaya, Natalia Ulanova, Elena Shilova, Natalia Volkova, Sofia Kilina, Elena Kornienko, Mikhail Kostik
Tatiana Gabrusskaya, Elena Kornienko, Department of Children's Diseases named after Professor I. M. Vorontsov, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Sankt-Peterburg, Russia
Natalia Ulanova, Elena Shilova, Natalia Volkova, Sofia Kilina, Department of Gastroenterology, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Sankt-Peterburg, Russia
Mikhail Kostik, Hospital Pediatry, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Sankt-Peterburg, Russia
Author contributions: Gabrusskaya T conducted a review of the published articles, performed data analysis, and provided interpretation; Gabrusskaya T, Ulanova N, Shilova E, Volkova N, and Kilina S contributed to software, resources, and data curation; Kornienko E designed the research study and participated in the interpretation of the results; Kostik M performed statistical analyses and contributed to the critical review of the manuscript; all authors have read and agreed to the published version of the manuscript.
Institutional review board statement: The study protocol was approved by the Institutional Review Board of Saint Petersburg State Pediatric Medical University on February 25, 2025. The study adhered to the ethical principles of the Declaration of Helsinki, ensuring the protection of participants’ rights. All data were collected and processed anonymously.
Informed consent statement: Informed consent was obtained from all subjects involved in the study.
Conflict-of-interest statement: The authors declare no conflicts of interest.
STROBE statement: The authors have read the STROBE Statement - checklist of items, and the manuscript was prepared and revised according to the STROBE Statement - checklist of items.
Data sharing statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Corresponding author: Mikhail Kostik, MD, PhD, Professor, Hospital Pediatry, Saint-Petersburg State Pediatric Medical University, Lytovskaya 2, Saint Petersburg 194100, Sankt-Peterburg, Russia. kost-mikhail@yandex.ru
Received: June 24, 2025 Revised: July 27, 2025 Accepted: November 7, 2025 Published online: March 9, 2026 Processing time: 256 Days and 20.2 Hours
Abstract
BACKGROUND
There is a limited number of studies on the efficacy and safety of dual-targeted therapy (DTT) in children with inflammatory bowel diseases (IBD); the latest reports focus on the combination of biological drugs with Janus kinase inhibitors (JAKI).
AIM
To evaluate the efficacy and safety of DTT in children with IBD.
METHODS
This retrospective cohort study included 18 IBD patients, aged 2-17 years, with 13 (72%) having Crohn's disease (CD) and 5 (28%) having ulcerative colitis, who were treated with DTT. In two children, two different combinations of DTT were used sequentially. The data on clinical and laboratory changes were assessed at the beginning of DTT and at three months (M3) and six months (M6). Fecal calprotectin and endoscopy were evaluated at baseline and M6.
RESULTS
A total of 20 courses of DTT in 18 patients were included in the analysis: (1) 12 (60%) were treated with JAKI and vedolizumab; (2) 6 (30%) with JAKI and ustekinumab; and (3) 2 (10%) with JAKI and adalimumab. Clinical remission was achieved in 9/20 (45%) and 13/20 (68%) DTT courses in patients within M3 and M6, respectively. In contrast, laboratory and endoscopic remission (ER) were achieved in 8/20 (40%) and 9/17 (53%) patients, respectively, within M6. Perianal lesions and upper gastrointestinal tract involvement were negatively associated with the efficacy of the DTT in CD patients. Children with early onset of the disease are more likely to achieve ER compared with those with later onset: 8/11 (73%) vs 1/6 (17%), respectively. Side effects were reported in 6/20 (30%) of cases, and 5/6 (83.3%) were considered non-serious.
CONCLUSION
A DTT may be considered for children with refractory IBD. This strategy was shown to be most effective among children with a very early onset of the disease.
Core Tip: We conducted a single-center retrospective cohort study on 18 children with inflammatory bowel disease who received dual-targeted therapy (DTT) with biologics and Janus kinase inhibitors. Clinical remission was achieved in 9 out of 20 (45%) and 13 out of 20 (65%) DTT courses at three months and six months (M6), respectively. In contrast, laboratory and endoscopic remission were achieved in 8 out of 20 (40%) and 9 out of 17 (53%) treatment courses, respectively, within M6 of treatment initiation. Predictors of poor response to DTT were perianal lesions and upper gastrointestinal tract involvement in Crohn’s disease. Early onset of inflammatory bowel diseases was associated with higher remission rates.
