Transitioning patients with inflammatory bowel disease from hospital-based to rapid home-based infliximab: A stepwise, safety and patient-orientated process towards sustainability

Table 1 Baseline characteristics comparing the standard infusion (n = 169) and rapid infusion (n = 129) cohorts

Variable	Standard, n (%)	Rapid, n (%)	P value
Male sex (%)	76 (45.0)	55 (42.6)	0.72
Age (yr) (median, range)	39 (20-88)	42 (18-86)	0.86
Low BMI (< 22 kg/m2)	17 (10.1)	13 (10.1)	0.84
High BMI (> 30 kg/m2)	28 (16.6)	31 (24.0)	0.14
Current smoker	28 (16.6)	26 (20.2)	0.45
Disease duration (yr) (median, range)	7 (0-49)	5 (0-36)	0.78
Disease type
CD	126 (74.6)	114 (88.4)	< 0.01
UC	43 (25.4)	14 (10.9)	< 0.01
Indeterminate	0 (0.0)	1 (0.8)	0.43
Extra-intestinal manifestation(s) documented	46 (27.2)	29 (22.5)	0.42
Psychiatric comorbidity documented	24 (14.2)	45 (34.9)	< 0.01
Concomitant medications
Corticosteroid	11 (6.5)	11 (8.5)	0.51
Immunomodulator	114 (67.5)	104 (80.6)	0.01
Thiopurine	91 (79.8)	70 (67.3)	0.04
Thiopurine ADR	32 (35.2)	32 (45.7)	0.20
Methotrexate	23 (20.2)	34 (32.7)	0.04
Methotrexate ADR	12 (52.2)	10 (29.4)	0.10
Prior biologic	21 (12.4)	20 (15.5)	0.40
Other anti-TNF	18 (85.7)	18 (90.0)	1.00

BMI: Body mass index; CD: Crohn’s disease; UC: Ulcerative colitis; ADR: Adverse drug reaction; anti-TNF: Anti-tumour necrosis factor.

Table 2 Infusion reactions per cohort, type and severity

	Standard cohort, n (%)	Rapid cohort, n (%)
	2214 infusions/169 patients	1461 infusions/129 patients
Mild reaction1
RR per infusion	0.8%	0.7%
RR per patient	10.7%	7.8%
Severe reaction1
RR per infusion	0.2%	0.00%
RR per patients	3.0%	0.00%
Total ADRs to infliximab	23 (%)	8 (%)
Mild ADRs1 (by subtype)	16 (69.6)	8 (100.0)
Serum sickness	1 (4.3)	1 (25.0)
Skin rash (including psoriasis/lupus)	6 (26.1)	4 (50.0)
Facial flushing	1 (4.3)	0 (0.0)
Hypoxia	0 (0.0)	2 (25.0)
Nausea	2 (8.7)	1 (12.5)
Pruritis	2 (8.7)	0 (0.0)
Arthralgia	1 (4.3)	0 (0.0)
Other (unspecified)	3 (13.0)	0 (0.0)
Severe ADRs1 (by subtype)	7 (30.4)	0 (0.0)
Anaphylactic (incl. angioedema)	4 (17.4)	0 (0.0)
Dyspnoea	1 (4.3)	0 (0.0)
Hypotension	1 (4.3)	0 (0.0)
Chest pain	1 (4.3)	0 (0.0)
Other (unspecified)	0 (0.0)	0 (0.0)
Retrial outcomes2
Returned to rapid	NA	7
Returned to accelerated	NA	1
Returned to standard	15	0
ADR(s) occurred on retrial	3	0

¹As per Common Toxicity Criteria definitions;

²Fastest protocol to which tolerated on ongoing basis (i.e., ≥ 3 infusions). RR: Relative risk; ADR: Adverse drug reaction; NA: Not available.

Table 3 Univariable and multivariable logistic regression analyses depicting factors potentially associated with increased likelihood of infliximab infusion reaction/s with a rapid infusion protocol in this cohort (n = 129)

Variable	Univariable odds ratio (95%CI)	P value	Multivariable odds ratio (95%CI)	P value
Lower BMI (< 22 kg/m2)	2.0 (0.7, 6.0)	0.15	5.3 (1.3, 21.6)	0.02
Presence of ≥ 1 extra intestinal manifestation	4.0 (1.4, 11.8)	0.01	8.8 (2.3, 33.5)	< 0.01
Disease duration ≥ 3 yr	4.8 (1.1, 20.5)	0.01	6.1 (1.1, 35.1)	0.04
Previous infliximab exposure (≥ 1 dose)	5.8 (1.2, 27.2)	0.02
Previous other biologic exposure (any other agent)	18.6 (1.6, 218.0)	0.03	34.9 (2.1, 576.7)	0.01
Previous break off infliximab (≥ 3 m)	5.1 (1.3, 19.4)	0.03	4.8 (0.8, 28.4)	0.08
Concurrent immunomodulator (any)	0.1 (0.01, 1.1)	0.06
Concurrent thiopurine	0.3 (0.1, 1.001)	0.06
Previous adverse drug reaction (any)	2.2 (0.7, 6.7)	0.12
Known psychiatric comorbidity	2.4 (0.8, 6.7)	0.10
Pre-medication used	0.5 (0.3, 1.00)	0.08

Final multivariable model characteristics: Omnibus goodness of fit chi-square = 28.9, P < 0.001, Nagelkerke’s R² = 0.40. BMI: Body mass index.

Table 4 Characteristics of home-based vs infusion centre-based rapid protocol groups

Variable	Home based rapid infusion group, n (%)	Infusion centre based rapid infusion group, n (%)	P value
Total patients/infusions	32 / 405	97/1067	-
Male (%)	18 (56.2)	37 (38.1)	0.10
Age (median, range)	36 (18, 79)	42(16, 86)	0.05
BMI > 30	7 (21.9)	24 (24.7)	0.82
Smoker	6 (18.8)	20 (20.6)	1.00
Disease type
CD	26 (81.2)	88 (90.7)	0.20
UC	6 (18.8)	8 (8.2)	0.11
Indeterminate	0 (0)	1 (1.0)	1.00
Extra-intestinal manifestations	9 (28.1)	20 (20.6)	0.46
Psychiatric co-morbidity	10 (31.2)	35 (36.1)	0.67
ADRs (any severity)	0 (0.0%)	8 (8.2)	0.20

BMI: Body mass index; CD: Crohn’s disease; UC: Ulcerative colitis; ADR: Adverse drug reaction.