Clinical Outcomes and Patient Experience of Biosimilar to Biosimilar Infliximab Switching in Patients with Inflammatory Bowel Disease: A Prospective, Single-Centre, Phase IV Interventional Study with a Nested Qualitative Study

Table 1

Patient demographics and clinical characteristics. Full details in supplement C.

	UC cohort	CD cohort	Complete cohort
Total number	28	105	133
Age—median (range) (years)	43 (19-74)	38 (18-90)	38 (18-90)
Male/female—no. (%)	16 (57.1)/12 (42.9)	58 (55.2)/47 (44.8)	74 (55.6)/59 (44.4)
Race—no. (%)
(i) White	24 (85.7)	99 (94.3)	123 (92.5)
(ii) Mixed	0 (0)	0 (0)	0 (0)
(iii) Asian or Asian background	1 (3.6)	4 (3.8)	5 (3.8)
(iv) Black or Black British	3 (10.7)	2 (1.9)	5 (3.8)
(v) Chinese	0 (0)	0 (0)	0 (0)
(vi) Other	0 (0)	0 (0)	0 (0)
BMI—median (range)	26.5 (19.7–40.2)	25.4 (16.6-48.4)	25.9 (16.6-48.4)
Smoking status—no. (%)
(i) Never	21 (75.0)	52 (49.5)	73 (54.9)
(ii) Current	0 (0)	22 (21.0)	22 (16.5)
(iii) Previous	7 (25)	31 (29.5)	38 (28.6)
Vaping status—no. (%)
(i) Never	26 (92.9)	97 (92.4)	123 (92.5)
(ii) Current	2 (7.1)	7 (6.7)	9 (6.8)
(iii) Previous	0 (0)	1 (1.0)	1 (0.8)
Duration of disease—median (range) (years)	3 (0-38)	8 (0-36)	7 (0-38)
Age at onset—no. (%)
(i) A1: <16		8 (7.6)
(ii) A2: 17-40		78 (74.3)
(iii) A3: >40		19 (18.1)
Site of Crohn’s disease—no. (%)
(i) L1: ileal		25 (23.8)
(ii) L2: colonic		30 (28.6)
(iii) L3: ileocolonic		50 (47.6)
(iv) L4: upper GI tract		4 (3.8)
Crohn’s disease behaviour—no. (%)
(i) B1: nonstricturing/nonpenetrating		65 (61.9)
(ii) B2: stricturing		16 (15.2)
(iii) B3: penetrating		24 (22.9)
(iv) p: perianal disease		17 (16.2)
Site of ulcerative colitis—no. (%)
(i) E1: proctitis	0 (0)
(ii) E2: left sided	14 (50.0)
(iii) E3: extensive	14 (50.0)
Concomitant medications at baseline—no. (%)
(i) Azathioprine/mercaptopurine	11 (39.3)	56 (53.3)	67 (50.4)
(ii) Methotrexate	6 (21.4)	14 (13.3)	20 (15.0)
Previous biologic history—no. (%)
(i) Remicade	7 (25.0)	45 (42.9)	52 (39.1)
(ii) Adalimumab	3 (10.7)	16 (15.2)	19 (14.3)