Clinical outcomes and drug sustainability after non-medical switch from ustekinumab originator to biosimilars in inflammatory bowel disease

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World Journal of Gastroenterology

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1007-9327

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World J Gastroenterol. Dec 28, 2025; 31(48): 114355
Published online Dec 28, 2025. doi: 10.3748/wjg.v31.i48.114355

Table 2 The clinical and biomarker efficacy of inflammatory bowel disease patients following the biosimilar switching, n (%)

	8 weeks before the switch	At switch (baseline)	Week 12 after the switch	Week 24 after the switch	P value
Clinical activity
Clinical remission	87	85.9	84.3	92.7	NS¹
IBD flares	NA	7.4	2.7	3.8	NS¹
Need for systemic corticosteroid	3.7	3.1	1.7	3.8	NS¹
Ustekinumab dose modification	NA	2.5	1.4	0	NS¹
Need for intestinal surgery	0	0	0	1.7	NS¹
Biomarker activity
Median CRP levels, mg/mL (IQR)	2.8 (1.1-4.5)	2.5 (1.1-4.7)	2.0 (1.0-4.2)	2.7 (0.7-7.8)	NS¹
Median FCAL levels mcg/g (IQR)	97.0 (46.0-353.0)	100.0 (74.0-342.3)	103.0 (71.5-246.0)	128.6 (58.6-262.5)	NS¹
Median hemoglobin level mg/mL (IQR)	135.0 (125.0-145.0)	138.0 (130.0-151.0)	139.0 (127.0-152.0)	136.0 (129.0-149.0)	NS¹
Median albumin level mg/mL (IQR)	42.0 (38.0-45.0)	41.0 (39.0 -45.0)	41.0 (39.0-43.0)	42.0 (38.0-46.0)	NS¹

¹NS: P value > 0.2.

CRP: C-reactive protein; FCAL: Fecal calprotectin; NA: Not applicable; NS: Non-significant.

Citation: Kritzinger J, Candel I, Kotrri G, Nadeem H, Afif W, Bitton A, Wild G, Bessissow T, Lakatos PL. Clinical outcomes and drug sustainability after non-medical switch from ustekinumab originator to biosimilars in inflammatory bowel disease. World J Gastroenterol 2025; 31(48): 114355
URL: https://www.wjgnet.com/1007-9327/full/v31/i48/114355.htm
DOI: https://dx.doi.org/10.3748/wjg.v31.i48.114355

Kritzinger J, Candel I, Kotrri G, Nadeem H, Afif W, Bitton A, Wild G, Bessissow T, Lakatos PL. Clinical outcomes and drug sustainability after non-medical switch from ustekinumab originator to biosimilars in inflammatory bowel disease. World J Gastroenterol 2025; 31(48): 114355 [PMID: 41480329 DOI: 10.3748/wjg.v31.i48.114355]

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