Self-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with inflammatory bowel disease: results of a multicenter survey

Figures & data

Table 1. General demographic data and reported efficacy in adalimumab and infliximab biosimilar-treated patients.

Characteristic	Overall, N = 179	Adalimumab, N = 73	Infliximab, N = 106	p-value
Sex, n (%)				0.042
Female	94 (53)	45 (62)	49 (46)
Male	85 (47)	28 (38)	57 (54)
Age (years), median (IQR)	41 (32, 47)	42 (32, 51)	41 (32, 47)	0.32
IBD Type, n (%)				0.74
CD	135 (75)	56 (77)	79 (75)
UC	44 (25)	17 (23)	27 (25)
UC extension, n (%)				0.85
E1, proctitis	8 (18)	3 (18)	5 (19)
E2, left-sided	13 (30)	4 (24)	9 (33)
E3, extensive	23 (52)	10 (59)	13 (48)
CD location, n (%)				0.036
L1, terminal ileum	33 (24)	19 (34)	14 (18)
L2, isolated colon	51 (38)	15 (27)	36 (46)
L3, ileocolon	51 (38)	22 (39)	29 (37)
Quality of life index, mean (SD)^1	2.28 (0.79)	2.30 (0.84)	2.27 (0.76)	0.93
Stool frequency per day, mean (SD)^2	1.44 (0.68)	1.45 (0.69)	1.44 (0.68)	0.96
Bloody stool, n (%)^2	16 (8.9)	1 (1.4)	15 (14)	0.003
Treatment duration with RP (months), median (IQR)	30 (18, 57)	24 (12, 48)	30 (18, 60)	0.067
Treatment duration with BS (months), median (IQR)	9.0 (6.0, 12.0)	11.0 (8.0, 12.0)	7.5 (6.0, 10.0)	<0.001
Previous biological therapy, n (%)	48 (27)	34 (47)	14 (13)	<0.001
Satisfaction rate with biosimilar therapy, n (%)				0.032
- I am satisfied, I am symptom-free	118 (66)	56 (77)	62 (58)
- I am partially satisfied, I am not completely symptom-free	55 (31)	16 (22)	39 (37)
- I am not satisfied, my symptoms are not controlled	6 (3.4)	1 (1.4)	5 (4.7)
Subjective efficacy of RP, mean (SD)^3	8.60 (1.78)	8.42 (1.93)	8.72 (1.68)	0.34
Subjective efficacy of BS, mean (SD)^3	8.18 (2.20)	9.02 (1.61)	7.77 (2.34)	<0.001
Intention to switch back to reference product, n (%)	-	42 (64)	-

¹1 = weak, 4 = excellent, ²last week average, ³1 = not effective, 10 = my complaints have completely disappeared, Abbreviations: BS: biosimilar, CD: Crohn's disease, IBD: inflammatory bowel disease, IQR: interquartile range, RP: reference product, SD: standard deviation, UC: ulcerative colitis, Significant values (p < 0.05) marked in bold.

Figure 1. Subjective efficacy of adalimumab and infliximab biosimilars in patients with inflammatory bowel disease.

Abbreviations: ADA: adalimumab, IFX: infliximab, RP: reference product, BS: biosimilar.

Table 2. Reported adverse events during infliximab and adalimumab biosimilar treatment.

Characteristic	Overall, N = 179	Adalimumab, N = 73	Infliximab, N = 106	p-value
AE, n (%)^1	120 (67)	62 (85)	58 (55)	<0.001
AESI, n (%)	92 (51)	41 (56)	51 (48)	0.29
Immediate allergic reaction, n (%)	11 (6.1)	3 (4.1)	8 (7.5)	0.53
Late allergic reaction, n (%)	33 (18)	14 (19)	19 (18)	0.83
Cardiac AE, n (%)	40 (22)	15 (21)	25 (24)	0.63
Infectious AE, n (%)	36 (20)	18 (25)	18 (17)	0.21
Cutaneous AE, n (%)	23 (13)	15 (20)	8 (7.5)	0.011
Arthralgia	45 (25)	24 (33)	21 (20)	0.047
Injection-site pain, n (%)	-	48 (66)	-

Abbreviations: AE: Adverse events, AESI: Adverse events of significance, Significant values (p < 0.05) marked in bold.