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

Table 1 Demographics and clinical characteristics of inflammatory bowel disease patients who underwent non-medical biosimilar switching, n (%)

Characteristics	IBD (n = 81)
CD/UC	69/12
Male gender	38 (46.9)
Median age at inclusion, years, (IQR)	42.0 (22.0-61.0)
Median duration of disease, years, (IQR)	12.0 (8.0-27.0)
Disease phenotype of CD
A1/A2/A3	31.9%/50.7%/17.4%
L1/L2/L3	17.4%/24.6%/58%
B1/B2/B3	53.6%/28.8%/19.7%
Disease phenotype of UC1
UC: E1/E2/E3	-/16.7/83.3
UC: S1/S2/S32	33.3/16.7/50
Upper GI involvement in CD	9 (14.0)
Perianal/fistulizing disease in CD	15 (21.7)
Extra-intestinal manifestation3	22 (27.2)
Previous intestinal surgery in CD4	35 (50.7)
Earlier medical therapy
Oral 5-ASA	39 (48.1)
Corticosteroid	72 (88.8)
Immunomodulators (AZA, MTX)	34 (42)/20 (24.7)
Ustekinumab originator dose before switch
Q8 week	30 (37)
Q6 week	2 (2.5)
Q4 week	49 (60.5)
Median duration of originators, months (IQR)	58 (31-89)
Biological exposure before ustekinumab originator	67 (82.7)
Multiple biologicals	16 (19.7)
Infliximab	44 (54.3)
Adalimumab	32 (39.5)
Vedolizumab	7 (8.6)

¹Disease location was classified using Montreal classification: E1, proctitis; E2, left-sided colitis; E3, extensive colitis; L1, terminal ileal; L2, colonic; L3 ileocolonic.

²Severe disease activity was defined as a partial Mayo score of 7-9 for ulcerative colitis.

³Extra-intestinal manifestation: Arthritis (15), spondylitis (14), uveitis (1), cutaneous (4), psoriasis (4).

⁴Type of previous surgeries; ileocecal resection (28), small bowel resection (11), colectomy and/or ileal pouch-anal anastomosis (16).

Three patients had certolizumab: And 1 patient golimumab. AZA: Azathioprine; CD: Crohn’s disease; IBD: Inflammatory bowel disease; IQR: Interquartile range; MTX: Methotrexate; UC: Ulcerative colitis; 5-ASA: 5-aminosalicylic acid.

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.