814 - Phase Iii Randomized Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with Innovator Infliximab in Patients with Active Crohn's Disease: 1-Year Maintenance and Switching Results

Ye, Byong Duk; Kim, Young Ho; Pesegova, Marina; Alexeeva, Olga; Осипенко, М. Ф.; Lahat, Adi; Dorofeev, A. E.; Salamon, Ágnes; Fishman, Sigal; Levchenko, Olena; Cheon, Jae Hee; Scribano, Maria Lia; Mateescu, Radu-Bogdan; Lee, Kang-Moon; Eun, Chang Soo; Lee, Sang Joon; Lee, Sung Young; Schreiber, Stefan

doi:10.1016/s0016-5085(18)30972-7

Cited by 10 publications

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“…Differences regarding the safety, efficacy or immunogenicity between CT-P13 and OI will not be addressed in the present study as their equivalence was extensively demonstrated for all indications in rigorous randomized clinical trials [ 25 – 27 , 30 – 32 ], assessed in a plethora of real-world studies [ 24 , 33 ], and is supported by the US Food and Drug Administration and the European Medicines Agency [ 34 , 35 ]. Hence, this retrospective cohort study aims to explore the reasons for CT-P13 discontinuation in patients who were treated with OI and were switched to CT-P13 (switchers), and in patients who did not receive OI prior to CT-P13 treatment (initiators) in a large tertiary hospital of western Switzerland.…”

Section: Introductionmentioning

confidence: 99%

Exploring the Reasons Behind the Substantial Discontinuation Rate Among Patients Taking CT-P13 in a Large Tertiary Hospital in Western Switzerland: A Retrospective Cohort Study Using Routinely Collected Medical Data

Krstic

Devaud

Marti

et al. 2022

Drugs - Real World Outcomes

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Background CT-P13 is an infliximab biosimilar that was granted market authorization in Switzerland in 2016. Despite the growing literature supporting the equivalence of CT-P13 compared with originator infliximab regarding the efficacy, safety, and immunogenicity and the undeniable cost-saving opportunities, CT-P13 remains widely underused in Switzerland. Objective Leaving aside the phenomenon of a low initiation rate, this study aimed to explore the reasons behind the high discontinuation rate observed among the patients taking CT-P13 in a large tertiary hospital in Western Switzerland. Methods We performed a retrospective cohort study using routinely collected data. Patients were eligible if they received originator infliximab or CT-P13 between September 2017 and December 2020. They were included if they had received at least two CT-P13 infusions during the same period. Patients were excluded if the follow-up was incomplete prior to or 6 months after their first CT-P13 infusion and if they had an oncological main diagnosis. Primary outcomes were the reasons for treatment discontinuation. Results One hundred and fifty-six patients were included and classified into two groups: switchers who were treated with originator infliximab and were switched to CT-P13 ( n = 85, 54%) and initiators who did not receive originator infliximab prior to CT-P13 treatment ( n = 71, 46%). Included patients belonged to three different groups of diagnosis: gastroenterological (67, 43%), rheumatological (61, 39%), and immunological (28, 18%). Twenty-three (27%) switchers and 35 (49%) initiators discontinued CT-P13 after 12 months. Main reasons for CT-P13 discontinuation were lack of efficacy ( n = 21, 36%) and secondary loss of response ( n = 16, 28%); however, objective assessments were not available. Initiators’ probability to discontinue CT-P13 at 12 months was significantly higher than switchers’ ( p < 0.01). Conclusions Lack of efficacy and secondary loss of response were the main reasons for the high CT-P13 discontinuation rate observed in a large tertiary hospital in Western Switzerland. Lack of active training and coordination among healthcare professionals and little education in patients may have exacerbated patients’ subjective complaints and increased the CT-P13 discontinuation rate. Supplementary Information The online version contains supplementary material available at 10.1007/s40801-022-00299-2.

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Section: Introductionmentioning

confidence: 99%

Exploring the Reasons Behind the Substantial Discontinuation Rate Among Patients Taking CT-P13 in a Large Tertiary Hospital in Western Switzerland: A Retrospective Cohort Study Using Routinely Collected Medical Data

Krstic

Devaud

Marti

et al. 2022

Drugs - Real World Outcomes

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“…Many clinical studies have revealed that CT-P13 possessed a su cient e cacy and safety equal to O-IFX, thus supporting switching from O-IFX to CT-P13 from a cost-effective perspective 2)3) . A recent international, randomized, double-blind study revealed no marked differences in the e cacy and safety among four switching groups (who received CT-P13 or in iximab without switching, or CT-P13 and then in iximab or in iximab and then CT-P13, with switching occurring at week 30) 3) . Although such large-scale studies have shown that the incidences of adverse events were not signi cantly different among the drugs, the immunogenicity of CT-P13 was not proven to be the same as that of O-IFX.…”

Section: Discussionmentioning

confidence: 98%

Drug-induced liver injury due to the infliximab biosimilar CT-P13 on switching from original infliximab in a patient with Crohn’s disease

Fujiya

Kashima

Kobayashi

et al. 2020

Preprint

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Background IBD are chronic immune disorders of unclear etiology. TNF inhibitors are effective for IBD treatment but are much more expensive than traditional treatments. A large number of clinical trials of infliximab biosimilar (CT-P13) have suggested that the administration of biosimilars provides high efficacy and safety similar to that of the originators, with a lower cost, so switching from the originator to the biosimilar is recommended. While several abnormalities of blood examination have been observed in patients with CT-P13 administration, no cases of drug-induced liver injury (DILI) caused by CT-P13 has been reported. Case presentations: A 32-year-old woman had been diagnosed with Crohn’s disease and was treated with original infliximab (O-IFX) for 9 years. She developed severe jaundice one month after switching from O-IFX to CT-P13. Serologic tests of auto-immune and hepatitis viruses were negative, and ultrasonography, computed tomography and magnetic resonance cholangiopancreatography revealed no abnormalities. A liver biopsy showed prominent pericentral canalicular cholestasis, without features of steatosis or sclerosing cholangitis, which was consistent with drug-induced cholestasis. The cholestasis improved 10 weeks after the discontinuation of CT-P13, and no DILI redeveloped even after re-switching from CT-P13 to O-IFX. This is the first report of DILI due to switching from O-IFX to CT-P13. Conclusions This is the first report of DILI due to switching from O-IFX to CT-P13, and our case suggests the different immunogenicity between O-IFX and CT-P13. While the efficacy and safety of CT-P13 are considered equal to those of O-IFX, clinicians need to be alert for certain severe DILIs when switching from O-IFX to CT-P13 with careful monitoring and appropriate treatment.

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Infliximab for maintenance of medically-induced remission in Crohn's disease

Gordon,

Sinopoulou,

Akobeng

et al. 2024

Cochrane Database of Systematic Reviews

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814 - Phase Iii Randomized Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with Innovator Infliximab in Patients with Active Crohn's Disease: 1-Year Maintenance and Switching Results

Cited by 10 publications

References 0 publications

Exploring the Reasons Behind the Substantial Discontinuation Rate Among Patients Taking CT-P13 in a Large Tertiary Hospital in Western Switzerland: A Retrospective Cohort Study Using Routinely Collected Medical Data

Exploring the Reasons Behind the Substantial Discontinuation Rate Among Patients Taking CT-P13 in a Large Tertiary Hospital in Western Switzerland: A Retrospective Cohort Study Using Routinely Collected Medical Data

Drug-induced liver injury due to the infliximab biosimilar CT-P13 on switching from original infliximab in a patient with Crohn’s disease

Infliximab for maintenance of medically-induced remission in Crohn's disease

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