Table 4.
Observational studies from abstracts
| Study | N | Intervention | Duration of follow-up | Effectiveness of medication | Discontinuation rate | Immunogenicity | Safety |
|---|---|---|---|---|---|---|---|
| Daperno M et al., 2018, Italy |
N = 69 n = 33 CD n = 36 UC |
Switch to CT-P13 (n = 54) Biologic-naïve patients started on CT-P13 (n = 15) |
<2 years | N/A | N/A | No significant difference in ADA and trough levels between the switch and naïve groups | The incidence of AEs is reduced in the switch vs. naïve group (p < 0.05) |
| Guerra Veloz MF et al., 2018, Spain |
N = 167 n = 116 CD n = 51 UD |
Switch to CT-P13 | 1 year |
Loss of response: 15.7%; Sustained remission rate (baseline vs. 1 year): CD: 88.8% vs. 69.7% (p > 0.05) UC: 84.3% vs. 76.7% (p > 0.05) |
9% | N/A | SAEs reported in 7.2% of patients |
| Hoivic ML et al., 2018, Norway |
N = 143 n = 99 CD n = 44 UC |
Switch to CT-P13 | 18 months | No significant change in disease activity scores | 8% | 1.4% of patients developed ADAs with clinical implications; 4.2% developed transient ADAs without loss of response | N/A |
| Ilias A et al., 2018, Hungary |
N = 117 n = 98 CD n = 19 UC |
Reverse switch from CT-P13 to IFX | 24 weeks | N/A | N/A | N/A | N/A |
| Petitdidier N et al., 2018, France |
N = 113 n = 83 CD n = 28 UC |
Switch to CT-P13 | 1 year | Loss of response: 12.4% | N/A | N/A | N/A |
| Pierik MJ et al., 2018, The Netherlands |
N = 119 n = 77 CD n = 42 UC |
Switch to CT-P13 | 6 infusions |
Mean (± SEM) change in disease activity compared with baseline: SCCAI: 0.1 ± 0.3 HBI: 0.5 ± 0.7 |
N/A | N/A | 53 AEs, including 3 non-related SAEs (melanoma, subarachnoid hemorrhage, hospitalization with fever) |
| Smits L et al., 2018, The Netherlands |
N = 83 n = 57 CD n = 24 UC n = 2 IBD-u |
Switch to CT-P13 | 2 years |
Loss of response: 12% (n = 10); No significant change in SCCAI or HBI |
32% |
No significant change in median drug trough levels; 2 developed ADAs after switch |
8 discontinued CT-P13 due to AEs |
| Choe YH et al., 2017, Republic of Korea |
N = 32 (pediatric) n = 25 CD n = 7 UC |
Switch to CT-P13 | 30 weeks |
Sustained remission rate: CD: 86.4% UC: 100% |
N/A | N/A |
2 had TEAEs 1 TESAE 1 had an IRR |
| Choe YH et al., 2017, Republic of Korea |
N = 83 n = 8 FCD: n = 75 CD: |
Switch to CT-P13 | N/A |
Sustained remission rate: FCD: 87.5% CD: 80% |
N/A | N/A | N/A |
|
Guidi L et al., 2017, Italy (PROSIT study) |
N = 680 n = 373 CD n = 307 UC |
Switch to CT-P13 (n = 109) TNFi-naïve initiated on CT-P13 (n = 400) Patients with previous biologic exposure initiated on CT-P13 (n = 171) |
≥2 infusions in switch group; safety analysis up to 1 year |
No efficacy analysis specific for the switch group; Loss of response (whole cohort): 10.3%; Deep remission rate (whole cohort): CD: 57% UC: 50% |
N/A | N/A | 92 SAEs (13.5%) were reported in whole cohort, leading to discontinuation in 73 patients (10.7%) |
| Huoponen S et al., 2017, Finland |
N = 56 n = 24 CD n = 29 UC n = 3 IBD-u |
Switch to CT-P13 | 16 weeks | No significant change in HBI or PM scores post-switch | N/A | N/A | No SAEs observed |
| Nugent S et al., 2017, Ireland | N = 33 | Switch to CT-P13 | 1 year | N/A | 15% | N/A | N/A |
| Rodriguez Glez GE et al., 2017, Spain |
N = 72 n = 62 CD n = 10 UC |
Switch to IFX biosimilar | 1 year |
Loss of response: 5.6%; Sustained remission rate (baseline vs. 1 year): 86% vs. 80.5% |
9.7% | N/A | 10 patients reported AEs; none resulted in treatment discontinuation |
| Sladek M et al., 2017, Italy & Poland |
N = 45 (pediatric) n = 38 CD n = 7 UC |
Switch to CT-P13 | 24–36 weeks | No significant change in disease activity after switch | 6.7% | One patient developed ADA post-switch | 1 discontinued due to AE with high ADA, which presented before switch to CT-P13 |
| Bettey M et al., 2016, UK | N = 134 | Switch to CT-P13 | 16 weeks | N/A | 1.5% | N/A | Similar incidence of AEs before and after switch |
| Díaz Hernández L et al., 2016, Spain |
N = 72 n = 62 CD n = 10 UC |
Switch to IFX biosimilar | 6 months |
Loss of response: 4.2% (1 primary non-response, 2 secondary loss of response); Sustained remission rate: Baseline: 86.1% 6 months: 86.1% |
4.2% | N/A |
5 AEs reported (2 infection, 1 cutaneous injury, 1 cephalea, 1 fever allergic reaction) None discontinued due to AEs |
| Guerra Veloz MF et al., 2016, Spain | N = 31 UC |
Switch to CT-P13 IFX Naive |
6 months |
Loss of response: 3 months (total 29 switch/1 naïve): 26.3% 6 months (total 15 switch/1 naïve): 30% |
N/A | N/A | Only mild AEs reported |
| Guerra Veloz MF et al., 2016, Spain | N = 71 CD |
Switch to CT-P13 IFX Naive |
6 months |
Loss of response: 3 months (total 60 switch/2 naïve): 27.7% 6 months (total 29 switch/2 naïve): 30% |
N/A | N/A | Only mild AEs reported |
| Hamanaka S et al., 2016, Japan |
N = 3 n = 2 CD n = 1 UC |
Switch to NK | 24 weeks | Sustained remission rate: 100% | N/A | N/A | N/A |
| Hlavaty T et al. 2016, Slovak Republic |
N = 12 n = 10 CD n = 2 UC |
Switch to CT-P13 (n = 12) | Up to 48 weeks |
Loss of response: 24 weeks: 0% (0/12) 32 weeks: 12.5% (1/8) 48 weeks: 25% (2/8) |
N/A | N/A | 1 developed psoriasiform dermatitis and discontinued treatment |
| Sieczkowska J et al. 2016, Poland | N = 16 CD (pediatric) | Switch to IFX biosimilar | 5 infusions | N/A | N/A | 100% (15/15) of patients maintained therapeutic drug levels; 26.7% (4/15) had ADA > 2 ng/mL | N/A |
| Kierkus J et al. 2015, Poland | N = 32 CD (pediatric) | Switch to CT-P13 | 8 weeks |
PCDAI (mean [range]): At switch: 8.5 (0–35) 8 weeks: 7.5 (0–23) |
N/A | N/A | No change in the incidence of mild AEs |
| Suk JY et al. 2015, Republic of Koreaa |
N = 42 n = 32 CD n = 10 UC |
Switch to CT-P13 | ≥1 infusion |
Loss of response: CD: 14% UC: 33% |
N/A | N/A | N/A |
ADA antidrug antibodies, AE adverse event, CD Crohn’s disease, FCD fistulizing Crohn’s disease, HBI Harvey-Bradshaw Index, IBD-u unclassified inflammatory bowel disease, IFX infliximab originator, IRR infusion-related reaction; N/A not available, NK Nippon Kayaku/Celltrion infliximab biosimilar (Japan), PCDAI Pediatric Crohn’s Disease Activity Index, PM partial Mayo score, PUCAI Pediatric Ulcerative Colitis Activity Index, SAE severe adverse event, SCCAI Simple Clinical Colitis Activity Index, SEM standard error of mean, TEAE treatment-emergent adverse event, TESAE treatment-emergent serious adverse event, TNFi tumor necrosis factor inhibitor, UC ulcerative colitis