Real-world experience and long-term outcomes of a mandatory non-medical switch of adalimumab originator to biosimilars in inflammatory bowel disease

Table 1 Baseline characteristics, n (%)

	Adalimumab originator (n = 43)	Adalimumab biosimilar switch (n = 228)	P value
Male gender	20 (46.5)	128 (56.1)	0.249
Age at switch (years ± SD)	46.1 ± 15.3	40.6 ± 14.9	< 0.001
Smoking	6 (14.0)	19 (8.33)	0.264
Age at inflammatory bowel disease diagnosis (years ± SD)	32.1 ± 15.7	26.3 ± 12.7	0.135
Crohn’s disease	35 (81.4)	192 (84.2)	0.654
Age at diagnosis
A1 (≤ 16)	4 (11.4)	47 (24.5)	0.122
A2 (17-40)	20 (57.1)	120 (62.5)	0.574
A3 (> 40)	11 (31.4)	26 (13.5)	0.011
Location
L1 (ileal)	12 (34.3)	69 (35.9)	1
L2 (colonic)	8 (22.9)	41 (21.4)	0.825
L3 (ileocolonic)	15 (42.9)	78 (40.6)	0.853
L4 (isolated upper tract disease)	1 (2.86)	1 (0.52)	0.285
Behaviour
B1 (non-stricturing, non-penetrating)	10 (28.6)	70 (36.4)	0.444
B2 (stricturing)	11 (31.4)	53 (27.6)	0.684
B3 (penetrating)	2 (5.71)	38 (19.8)	0.052
Perianal disease modifier	11 (31.4)	65 (33.9)	0.847
Ulcerative colitis	8 (18.6)	36 (15.8)
E1 (ulcerative proctitis)	1 (12.5)	1 (2.78)	0.334
E2 (left-sided colitis)	1 (12.5)	9 (25.0)	0.659
E3 (extensive colitis)	6 (75.0)	26 (72.2)	1
Extraintestinal manifestations
Skin	3 (6.98)	27 (11.8)	0.437
Joint	6 (14.0)	38 (16.7)	0.823
Eye	4 (9.30)	10 (4.38)	0.249
Primary sclerosing cholangitis	0	1 (0.44)	1
Concurrent immunomodulator therapy (azathioprine/methotrexate)	4 (9.30)	39 (17.1)	0.258
Concurrent corticosteroid use	3 (6.98)	11 (4.82)	0.473
Duration on adalimumab prior to switch (months ± SD)	89.5 ± 206.0	64.5 ± 40.3	0.719
Pre-switch C-reactive protein (mg/L ± SD)	2.21 ± 1.99	6.46 ± 22.0	0.359
Pre-switch fecal calprotectin (mcg/g ± SD)	215.6 ± 279.7	203.8 ± 413.6	0.972

Table 2 Adverse outcomes of biosimilar switch leading to treatment discontinuation, n (%)

	Adalimumab originator (n = 43)	Adalimumab biosimilar switch (n = 228)	P value
Duration on biosimilar after switch (months ± SD)	-	24.4 ± 7.08	-
Discontinuation of adalimumab	7 (16.3)	27 (11.8)	0.451
Reason for discontinuation
Loss of response	2 (4.65)	14 (6.11)	1
Adverse events	2 (4.65)	10 (4.39)	1
Other patient factors	3 (6.98)1	3 (1.31)2	0.053

¹Patient factors include: Self-discontinued medication without provider consultation given patient asymptomatic, financial barriers, and self-discontinuation for undisclosed reasons.

²Patient factors include: Self-discontinued due to the coronavirus disease 2019 pandemic, stopped due to patient reporting difficulty coordinating doses, self-discontinuation for undisclosed reasons.

Table 3 Adverse outcomes of biosimilar switch leading to treatment discontinuation: originator vs biosimilars, n (%)

	Adalimumab originator (n = 43)	Idacio (MSB11022; n = 27)	Hadlima (SB5; n = 63)	Hulio (FKB327; n = 86)	Hyrimoz (GP2017; n = 48)	Amgevita (ABP 501;n = 4)	P value
Duration on biosimilar after switch (months ± SD)	-	26.0 ± 2.83	24.9 ± 5.32	22.3 ± 9.52	26.5 ± 4.64	26.3 ± 1.26	0.131
Discontinuation of adalimumab	7 (16.3)	2 (7.41)	4 (6.35)	19 (22.1)	2 (4.17)	0
Reason for discontinuation
Loss of response	2 (4.65)	1 (3.70)	1 (1.59)	12 (14.0)	0	0
Adverse events	2 (4.65)	0	3 (4.76)	5 (5.81)	2 (4.17)	0
Other patient factors	3 (6.98)	1 (3.70)	0	2 (2.33)	0	0

Table 4 Treatment persistence subgroup analysis in patients with ulcerative colitis and Crohn’s disease, n (%)

Inflammatory bowel disease subtype			Treatment persistence by 30 months	Treatment discontinuation by 30 months	Total	P value
Ulcerative colitis	Drug group	Biosimilar	31 (86.1)	5 (13.9)	36	1.0
		Originator	7 (87.5)	1 (12.5)	8
	Total		36	6	44
Crohn’s disease	Drug group	Biosimilar	170 (88.5)	22 (11.5)	192	0.400
		Originator	29 (82.9)	6 (17.1)	35
	Total		199	28	227
Total	Drug group	Biosimilar	201 (88.2)	27 (11.8)	228	0.451
		Originator	36 (83.7)	7 (16.3)	43
	Total		237	34	271