Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease

Figures & data

Figure 1. PRISMA diagram.

ACG, American College of Gastroenterology; DDW, Digestive Disease Week®; ECCO, European Crohn’s and Colitis Organisation; L1, title and abstract eligibility screening according to inclusion and exclusion criteria; L2, full-text screening; UEG, United European Gastroenterology.

Figure 2. Switch pattern in the included studies.

Table 1. RCTs evaluating switching from IFX originator (oIFX) to biosimilar (N = 2), IFX biosimilar to oIFX (N = 1) or IFX biosimilar maintenance (N = 1).

Author, yearCountry	Reference	Study design Sample size Study period	Population	Transition Timing of switch	Age (years) Female, n (%) Disease duration (months)	Clinical outcomes assessed	PROs assessed	Safety outcomes assessed	Summary
Jørgensen, 2017; Goll, 2019; Jørgensen, 2020 Norway	[66–68]	RCT N = 77 OLE N = 65 Oct 2014 to Jul 2016	CD	oIFX → CT-P13 after ≥6 months’ oIFX treatment	Age: 39.5 (14.2)^a F: 30 (39) Disease duration: 14.3 (8.5)^a	HBI, PGA, CRP, Fc, Remission, Disease worsening	EQ-5D index score, IBDQ, SF-36, WPAI	Overall AEs, TEAEs after switch, SAEs, Discontinuation due to AE, ADAs, All treatment discontinuation	Efficacy, safety and immunogenicity of both the originator and biosimilar IFX were comparable in patients with CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from oIFX to CT-P13 in patients with CD and UC
		RCT N = 46 OLE N = 42 Oct 2014 to Jul 2016	UC	oIFX → CT-P13 after ≥6 months’ oIFX treatment	Age: 44.4 (14.8)^a F: 14 (30) Disease duration: 11.5 (7.5)^a	PMS, PGA, CRP, Fc, Remission, Disease worsening
		OLE of RCT N = 62 Oct 2014 to Jul 2016	CD	oIFX for 52 weeks in RCT → CTP13 in OLE	Age: 40.2 (13.1)^a F: 27 (44) Disease duration: 15.2 (9.1)^a	PGA, CRP, Fc, Remission, Disease worsening	IBDQ	Overall AEs, TEAEs after switch, SAEs, Discontinuation due to AE, ADAs, All treatment discontinuation
		OLE of RCT N = 38 Oct 2014 to Jul 2016	UC	oIFX for 52 weeks in RCT → CTP13 in OLE	Age: 45.9 (13.4)^a F: 14 (37) Disease duration: 13.7 (9.5)^a	PMS, Fc, Remission, Disease worsening
Ye, 2019 (PLANET-CD) Multinational	[55]	RCT N = 220 Aug 2014 to Feb 2017	CD (all-randomized population)	CT-P13 → CT-P13 CONTINUERS at week 30 n = 56	Age: 39.0 (19.0–68.0)^b F: 27 (48.2) Disease duration <3 years: 34 (60.7)^c ≥3 years: 22 (39.3)^c	CDAI, CRP, Fc, Remission, Mucosal healing	PRO-2 score, SIBDQ score	TEAEs, SAEs, Discontinuation due to AE, ADAs, All treatment discontinuation	On the whole, prespecified non-inferiority criteria were met for both populations, and CT-P13 was considered non-inferior to oIFX. CDAI-70 or CDAI-100 response rates and clinical remission rates between groups were similar at weeks 6, 14, 30 or 54. PRO-2 scores improved after study drug infusion, with no notable difference in PRO-2 scores between groups at any time-point. There were no notable differences between the CT-P13 and oIFX groups. Mean Fc concentrations decreased from baseline to week 6 and then remained stable, with no notable differences between groups at any visit. Mean CRP concentrations decreased from baseline to week 6 and then remained stable, with no notable differences between groups
				CT-P13 → oIFX with switching at week 30 n = 55	Age: 31.0 (18.0–69.0)^b F: 21 (38.2) Disease duration <3 years: 27 (49.1)^c ≥3 years: 28 (50.9)^c
				oIFX → oIFX continuers at week 30 n = 54	Age: 31.0 (18.0–69.0)^b F: 28 (51.9) Disease duration <3 years: 30 (55.6)^c ≥3 years: 24 (44.4)^c
				oIFX → CT-P13 with switching at week 30 n = 55	Age: 35.0 (19.0–63.0)^b F: 21 (38.2) Disease duration <3 years: 29 (52.7)^c ≥3 years: 26 (47.3)^c

Abbreviations: ADA, anti-drug antibody; AE, adverse event; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; CT-P13, infliximab biosimilar; F, female; Fc, fecal calprotectin; HBI, Harvey – Bradshaw Index; IBDQ, Inflammatory Bowel Disease Questionnaire; IFX, infliximab; N, sample size at baseline; n, subset of sample; oIFX, originator infliximab; OLE, open-label extension; PGA, Physician’s Global Assessment; PMS, partial Mayo Score; PRO, patient-reported outcome; RCT, randomized controlled trial; SAE, serious adverse event; SF-36, 36-Item Short Form Health Survey; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; TEAE, treatment-emergent adverse event; UC, ulcerative colitis; WPAI, Work Productivity and Activity Impairment Questionnaire.

^aMean (SD).

^bMedian (IQR).

^cn (%).

Table 2. Mucosal healing associated with switching from (A) IFX originator (oIFX) to biosimilar (N = 4) or (B) IFX biosimilar to oIFX or biosimilar maintenance (N = 1) in patients with CD in RCTs and longitudinal studies.

Author, yearCountry	Reference	Study design	Sample size	Follow-up time	Transition	Outcome results
(A) IFX originator to biosimilar
Ye, 2019 (PLANET-CD) Multinational	[55]	RCT	N = 55	Absolute: 12.5 months	oIFX → CT-P13	SES-CD score: mean (SD), 7.8 (6.70) 12.5 months: n (%), 8 (21.1); N = 38
Armuzzi, 2019; Fiorino, 2017 Italy	[69,70]	Observational prospective	N = 87	Mean (SD): 12.9 (7.6) months Median (IQR): 11.7 (6.04–20.7) months	oIFX → CT-P13	SES-CD score: mean (SD) Baseline: 3.7 (4.5), n = 87 6 months (a): NR, n = 78 12 months (b): 1.5 (2), n = 48; p = 0.06
Padival, 2021; Padival, 2020 USA	[45,46]	Observational prospective	NR	NR	oIFX → SB2	SES-CD score: median (IQR), improvement 0 (−3, 0), N = 7; p = 0.57
Tursi, 2019;Tursi, 2017Italy	[71,72]	Observational retrospective, Observational prospective	N = 45	Absolute: 12 months	oIFX → CT-P13	Mucosal healing during folow-up, n (%): 16 (84.2); N = 19
(B) IFX biosimilar to originator or biosimilar maintenance
Ye, 2019 (PLANET-CD) Multinational	[55]	RCT	N = 56	Absolute: 12.5 months	CT-P13 → CT-P13	SES-CD score: mean (SD), 10.3 (9.09) 12.5 months: n (%), 16 (33.3); N = 48
	[55]	RCT	N = 55	Absolute: 12.5 months	CT-P13 → oIFX	SES-CD score: mean (SD), 10.4 (7.79) 12.5 months: n (%), 12 (26.1); N = 46

Abbreviations: CD, Crohn’s disease; CT-P13, infliximab biosimilar; IFX, infliximab; IQR, interquartile range; n, sample with outcome; N, total sample size; NR, not reported; oIFX, originator infliximab; RCT, randomized controlled trial; SB2, infliximab-abda biosimilar; SD, standard deviation; SES-CD, Simple Endoscopic Score for Crohn’s Disease.

Table 3. Summary of TEAEs in RCTs, and overall AEs and SAEs in longitudinal studies in patients with IBD switching from IFX originator (oIFX) to biosimilar.

Author, yearCountry	Reference	Population or subpopulation	Study design	Sample size	Follow-up	Transition	TEAEs	SAEs
Jørgensen, 2017; Goll, 2019; Jørgensen, 2020 Norway	[66–68]	CD	RCT	N = 77	12 months	oIFX → CT-P13	Number of events: 130 Patients: n (%), 57 (74)	Number of events: 9 Patients: n (%), 8 (10)
			OLE of RCT	N = 62	6 months	oIFX → CT-P13	Number of events: 28 Patients: n (%), 18 (29)	Number of events: 4 Patients: n (%), 3 (5)
		UC	RCT	N = 46	12 months	oIFX → CT-P13	Number of events: 65 Patients: n (%), 29 (63)	Number of events: 3 Patients: n (%), 3 (7)
			OLE of RCT	N = 38	6 months	oIFX → CT-P13	Number of events: 20 Patients n (%) 14 (37)	Number of events: 2 Patients: n (%), 2 (5)
Ye, 2019 (PLANET-CD) Multinational	[55]	CD	RCT	N = 55	Absolute: 12.5 months	oIFX → CT-P13	Patients: n (%), 21 (38)	TEAEs: n (%), 2 (4)
Armuzzi, 2019; Fiorino, 2017 Italy	[69,70]	IBD	Observational prospective	N = 155	Mean (SD): 12.9 (7.6) months	oIFX → CT-P13	NR	Total SAEs: n (%), 18 (11.6)
Bergqvist, 2018 Sweden	[76]	IBD	Observational prospective	N = 313	Absolute: 12 months	oIFX → CT-P13	NR	Number of events (%), 7 (2.2)
		CD	Observational prospective	N = 195	Absolute: 12 months	oIFX → CT-P13	Patients: n (%), 47 (24.1)	Patients: n (%), 4 (2.1)
		UC	Observational prospective	N = 118	Absolute: 12 months	oIFX → CT-P13	Patients: n (%), 25 (21.2)	n (%), 3 (2.5)
Binkhorst, 2018 Netherlands	[32]	IBD	Observational retrospective	N = 197	3.7 months	oIFX → CT-P13	Adverse reaction in patients: n (%) after switch, 12 (6.1)	NR
Bronswijk, 2020 Belgium	[79]	IBD	Observational prospective	N = 361	Absolute: 6 months	oIFX → CT-P13	n/N (%), 8/361 (2.2)	NR
Chaparro, 2019 Spain	[81]	IBD	Observational retrospective	N = 199	Median (IQR): 18 (10–22) months	oIFX → CT-P13	During follow-up: n (%), 48 (10.08) Number of events: 61	NR
Cheon, 2021; South Korea, EU	[56]	IBD	Observational retrospective	N = 63	Absolute: 60 months	oIFX → CT-P13	n (%), 42 (66.7)	NR
Eberl, 2017 Finland	[82]	IBD	Observational prospective	N = 62	3.7 months	oIFX → CT-P13	Number of events: 4	NR
Fischer, 2021 Germany	[83]	IBD	Observational prospective	N = 144	Absolute: 18.5 months	oIFX → SB2	n/N (%), 40/144 (27.8)	SAE, number of events: 11 (breast and prostate carcinoma, neuroendocrine malignancy, liver abscess, bronchopulmonary infection, intestinal surgical procedures)
Guerra Veloz, 2019; Argüelles-Arias, 2017, Argüelles-Arias, 2017 Spain	[73,74,86]	IBD	Observational prospective	N = 100	Absolute: 24 months	oIFX → CT-P13	n (%), 14 (14)	n (%), 14 (14)
Guerra Veloz, 2018 Spain	[115]	IBD	Observational prospective	N = 167	Absolute: 12 months	oIFX → CT-P13	n (%), 12 (7.2)	Number of events: 3 (3 AEs were considered as SAEs)
Guerra Veloz, 2018 Spain	[114]	IBD	Observational prospective, Observational retrospective	N = 98	Absolute: 24 months	oIFX → CT-P13	AE: n (%), 11 (11.2)	NR
		CD	Observational	N = 67	Absolute: 12 months	oIFX → CT-P13	NR	Patients: n (%), 1 (1.49)
		UC	Observational prospective, Observational retrospective	N = 31	Absolute: 24 months	oIFX → CT-P13	NR	n (%), 1 (3.25)
Guerrero Puente, 2017 Spain	[87]	IBD	Observational retrospective	N = 36	Mean (SD): 8.4 (3.5) months	oIFX → CT-P13	n (%), 4 (11.11)	NR
		CD	Observational retrospective	N = 23	NR	oIFX → CT-P13	Patients: n (%), 3 (8.3)	NR
Guiotto, 2019 Italy	[108]	IBD	Observational retrospective	N = 66	Absolute: 12 months	oIFX → CT-P13	n/N (%), 7/66 (10.60)	NR
Hoivik, 2018; Buer, 2017 Norway	[80,89]	IBD	Observational prospective	N = 143	Absolute: 18 months	oIFX → CT-P13	n (%), 74 (51.7) Number of events: 113	n/N (%), 5/113 (4.4)
		CD	Observational prospective	N = 99	Absolute: 18 months	oIFX → CT-P13	Patients: n (%), 14 (14.1)	NR
		UC	Observational prospective	N = 44	Absolute: 18 months	oIFX → CT-P13	n (%), 3 (6.81)	NR
Hlavaty, 2016 Slovakia	[88]	CD	Observational retrospective	N = 10	12.92 months	oIFX → CT-P13 maintenance	Patients: n (%), 1 (10)	NR
Kim, 2019 South Korea	[49]	IBD	Observational retrospective	N = 101	Absolute: 60 months	oIFX → CT-P13	n (%), 13 (12.87)	NR
		CD	Observational retrospective	N = 78	Absolute: 60 months	oIFX → CT-P13	Patients: n (%), 12 (15.4)	NR
		UC	Observational retrospective	N = 23	Absolute: 60 months	oIFX → CT-P13	n (%), 1 (4.3)	NR
Kolar, 2017 Czech Republic	[92]	IBD	Observational prospective	N = 74	Absolute: 12.92 months	oIFX → CT-P13	n (%), 35 (47.29)	NR
Macaluso, 2021; Macaluso, 2020 Italy	[60,94]	IBD	Observational prospective	N = 17	NR	oIFX → SB2	NR	Number of events: 3 (IRs and infections) occurred in three patients n (%), 3 (17.6)
Mahmmod, 2021; Mahmmod, 2020 Netherlands	[35,40]	IBD	Observational retrospective	N = 684	Absolute: 12 months	oIFX → CT-P13	NR	IBD-like symptoms: n (%), 176 (25.7), Dermatological symptoms, n (%): 150 (21.9)
Massimi, 2021 Italy	[96]	IBD	Observational prospective	N = 85	Mean (range):first follow-up after switch,4.4 (1.8–66.1) months;Second follow-up after switch, 10.8 (6.2–13.5) months	oIFX → SB2	First follow-up visit, number of events: 4 Second follow-up visit, number of events: 5	NR
Mazza, 2022; Mazza, 2020 Italy	[61,97]	IBD	Observational retrospective	N = 66	Median (range):37 (3–58)	oIFX → CT-P13	Overall AE: N = 66; n (%), 8 (12.1); p = 0.772	NR
Nakagawa, 2019 Japan	[50]	IBD	Observational prospective	N = 219	Absolute: 24 months	oIFX → CT-P13	All ADRs: n (%), 24 (11.0)	NR
		IBD	Observational prospective	N = 38	Absolute: 24 months	oIFX → CT-P13	All ADRs: n (%), 13 (34.2)	NR
Petitdidier, 2019 France	[99]	IBD	Observational prospective	N = 113	Absolute: 12.5 months	oIFX → CT-P13	n (%), 20 (18.0)	n (%), 2 (1.8)
Privitera, 2020 NR	[101]	IBD	Observational prospective	N = 96	Absolute: 12 months	oIFX → CT-P13	n (%), 38 (39.6)	NR
Pugliese, 2021 Italy	[102]	IBD	Observational prospective	N = 119	Median (range): 69.6 (9.6–189.6) months	oIFX → CT-P13	n (%), 24 (20.16)	NR
Ratnakumaran, 2018 UK	[103]	IBD	Observational prospective	N = 191	Absolute: 12 months	oIFX → CT-P13	12 months post switch: n (%), 9 (4.7) 12-month non-switch group: n (%), 0 (0); p = 1.0	NR
		CD	Observational prospective	N = 44	Absolute: 12 months	oIFX → CT-P13	12 months post switch: n (%), 2 (4.5)	NR
Razanskaite, 2017 UK	[104]	IBD	Observational	N = 143	NR	oIFX → CT-P13	Number of events (after 3rd dose of CT-P13): 88; total number of patients reporting AEs: 94 Number of events (before switch): 105; total number of patients reporting AEs: 94	NR
Schmitz, 2018 Netherlands	[36]	IBD	Observational prospective	N = 133	12 months	oIFX → CT-P13	n (%), 13 (9.8)	NR
Sieczkowska, 2016 Poland	[105]	CD	Observational prospective	N = 32	11 months Mean (SD) (range) follow-up: 8 (2.6) (2–11) months	oIFX → CT-P13	AEs during therapy with IFX biosimilar: n = 20	NR
		UC	Observational prospective	N = 7	Mean (SD): 5 (3.6) months	oIFX → CT-P13	AEs during therapy with IFX biosimilar: patients, n = 3	NR
Smits, 2019; Smits, 2017; Smits, 2016 Netherlands	[37–39]	IBD	Observational prospective	N = 83	Absolute: 24 months	oIFX → CT-P13	24 months: n (%), 19 (22.8) Number of events: 22	NR
Strik, 2018 Netherlands and Belgium	[106]	IBD	Observational prospective	N = 118	Absolute: 3.7 months	oIFX → CT-P13	Patients with ≥ 1 AE: n (%), 94 (80)	Patients with ≥ 1 SAE: n (%), 5 (4)
		CD	Observational prospective	N = 60	Absolute: 16 weeks (AEs), 3.7 months (SAEs)	oIFX → CT-P13	Patients with ≥ 1 AE: n (%), 46 (77) Number of events: 132	Patients with ≥ 1 SAE: n (%), 3 (5) Number of SAEs: 6 Patients with ≥ 1 SAE: n (%), 3 (5) SAEs, number of events: 3
		UC	Observational prospective	N = 58	Absolute: 3.7 months	oIFX → CT-P13	Patients with ≥ 1 AE: n (%), 48 (83) Number of events: 118	Patients with ≥ 1 SAE: n (%), 3 (5) Number of SAEs: 2 Patients with ≥ 1 SAE: n (%), 3 (5); number of events: 3
Trystram, 2021 France	[59]	IBD	Observational prospective	N = 158	Absolute: 12.5 months	oIFX → CT-P13	n (%), 63 (39.9) Number of events: 77	n (%), 10 (6.3)
Tursi, 2019; Tursi, 2017 Italy	[71,72]	CD	Observational retrospective, Observational prospective	N = 45	Median (IQR): 24 (6–24) months Absolute: 12 months	oIFX → CT-P13	Patients: n (%), 1 (0.7)	NR
Yoo, 2020 US	[48]	IBD	Observational retrospective	N = 55	Average: 13.9 months	oIFX → CT-P13	Drug-related AEs: n (%), 11 (20)	NR
Van Hoeve, 2019 Belgium	[107]	IBD	Observational prospective in pediatric patients	N = 42	Absolute: 6 months	oIFX → CT-P13	AEs may have occurred more than once in a single patient 6 months prior to switch: total number of events, 65 6 months after switch: total number of events: 45; p = 0.317	Hospitalization (due to disease exacerbation): n (%), 1 (2.38)
Kang, 2015 South Korea	[52]	UC	Observational retrospective	N = 4	Median: 9.6 months	oIFX → CT-P13	AE (arthralgia): n/N (%), 1/4 (25)	NR

Abbreviations: ADR, adverse drug reaction; AE, adverse event; CD, Crohn’s disease; CT-P13, infliximab biosimilar; IBD, inflammatory bowel disease; IFX, infliximab; IQR, interquartile range; IR, infusion reaction; n, sample with outcome; N, total sample size; NR, not reported; oIFX, originator infliximab; OLE, open-label extension; RCT, randomized controlled trial; SAE, serious adverse event; SB2, infliximab-abda biosimilar; SD, standard deviation; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.

Figure 3. Percentage of patients with (a) AEs and (b) SAEs in patients with IBD after switching from oIFX to biosimilar in longitudinal studies.

AE, adverse event; IBD, inflammatory bowel disease; oIFX, originator infliximab; SAE, serious adverse event.

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Data availability statement

All data generated or analyzed during this study are included in this published article or as supplementary information files.