Subcutaneous infliximab CT-P13 as second-line treatment after failure of anti-TNF therapy in patients with Crohn’s disease

Česká verzia

Authors: M. Kolář ¹ ; M. Lukáš ¹ ; D. Ďuricová ¹ ; K. Vlková ¹ ; A. Gojdičová ² ; T. Hlavatý ² ; Karin Černá ³
Authors place of work: Klinické a výzkumné centrum pro idiopatické střevní záněty ISCARE a. s. a 1. LF UK, Praha ¹; Gastroenterologické centrum Bezručova, Bratislava ²; Alergologie a klinická imunologie, Gennet, Praha ³
Published in the journal: Gastroent Hepatol 2026; 80(1): 30-35
Category: IBD: původní práce
doi: https://doi.org/10.48095/ccgh202630

Summary

This pilot, prospective, observational two-center study evaluated the efficacy and safety of subcutaneous infliximab CT-P13 S.C. as a second-line treatment in patients with moderate-to-severe Crohn’s disease who had experienced treatment failure with previous intravenous infliximab or adalimumab therapy. Sustained therapeutic response after switching administration methods was observed in 70% of patients, while plasma infliximab concentrations during subcutaneous administration reached more than three-fold higher levels compared with baseline. Half of the patients who exhibited signs of disease activity at the time of treatment transition achieved complete clinical remission. Treatment was discontinued prematurely in 30% of patients due to lack of efficacy or adverse events.

Keywords:

biological therapy – Crohn‘s disease – infl iximab CT-P13 S.C.

Zdroje

1. Černá K, Ďuricová D, Lukáš M et al. Subkutánní infliximab v léčbě refrakterních pacientů s Crohnovou chorobou –⁠ pilotní studie imunogenicity léčiva. Gastroent Hepatol 2023; 77 (5): 419–426. doi: 10.48095/ccgh2023419.

2. Smith PJ, Critchley L, Storey D et al. Efficacy and safety of elective switching from intravenous to subcutaneous infliximab [CT-P13]: a multicentre cohort study. J Crohns Colitis 2022; 16 (9): 1436–1446. doi: 10.1093/ecco-jcc/ jjac053.

3. Reissigová J, Černá K, Lukáš M et al. „Switch“ z biosimilárního infliximabu CT-P13 na biosimilární infliximab SB-2 v dlouhodobé udržovací terapii IBD pacientů: prospektivní observační studie. Gastroent Hepatol 2023; 77 (4): 336–341. doi: 10.48095/ccgh2023336.

4. Harvey RF, Bradshaw MJ. Measuring Crohn‘s disease activity. Lancet 1980; 1 (8178): 1134–1135. doi: 10.1016/s0140-6736 (80) 91577-9.

5. D‘Amico F, Solitano V, Aletaha D et al. Biobetters in patients with immune-mediated inflammatory disorders: an international Delphi consensus. Autoimmun Rev 2021; 20 (7): 102849. doi: 10.1016/j.autrev.2021.102849.

6. Alten R, An Y, Kim DH et al. Re-routing infliximab therapy: subcutaneous infliximab opens a path towards greater convenience and clinical benefit. Clin Drug Investig 2022; 42 (6): 477–489. doi: 10.1007/s40261-022-01162-6.

7. Schreiber S, Danese S, Colombel JF et al. Comparative efficacy and safety of advanced therapies in maintenance treatment of adult patients with moderate-to-severe Crohn‘s disease: a systemic literature review and network meta-analysis. Adv Ther 2026. doi: 10.1007/s12325-025-03447-6.

8. Černá K. Kulatý stůl: subkutánní infliximab v léčbě IBD a terapeutické monitorování hladiny léčiva v klinické praxi. Gastroent Hepatol 2023; 77 (2): 147–153. doi: 10.48095/ccgh 2023147.

9. Cerna K, Duricova D, Lukas M et al. Subcutaneous infliximab in refractory Crohn‘s disease patients: a possible biobetter? Crohns Colitis 360 2023; 5 (4): otad040. doi: 10.1093/crocol/otad040.

10. Kim KW, Kang WH, Koh SJ et al. A real world comparison of subcutaneous to intravenous administration of infliximab in patients with inflammatory bowel disease. Intest Res 2025; 23 (4): 483–490. doi: 10.5217/ir.2025.00001.

Doručeno/Submitted: 9. 2. 2026

Přijato/Accepted: 13. 2. 2026

Korespondenční autor

prof. MUDr. Milan Lukáš, CSc., AGAF

Klinické a výzkumné centrum pro střevní záněty

ISCARE a. s. a 1. LF UK, Praha

Českomoravská 19

190 00 Praha 9

milan.lukas@email.cz