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

(3 citation statements)

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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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“…To date, switching from OI to CT-P13 has not posed major issues. Indeed, their equivalence has been extensively demonstrated in rigorous randomized clinical trials [ 28 – 33 ], assessed in reviews that have gathered a plethora of real-world studies [ 34 , 35 ] and is supported by the U. S. Food and Drug Administration and the European Medicines Agency [ 8 , 27 , 36 , 37 ]. CT-P13 was infliximab’s first biosimilar approved by the EU in 2013 and was granted market access in Switzerland in 2016 [ 27 , 38 ].…”

Section: Introductionmentioning

confidence: 99%

Does the introduction of an infliximab biosimilar always result in savings for hospitals? A descriptive study using real-world data

Krstic,

Devaud,

Sadeghipour

et al. 2024

Health Econ Rev

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Background Biosimilars are biologic drugs that have the potential to increase the efficiency of healthcare spending and curb drug-related cost increases. However, their introduction into hospital formularies through initiatives such as non-medical switching must be carefully orchestrated so as not to cause treatment discontinuation or result in increased health resource utilization, such as additional visits or laboratory tests, among others. This retrospective cohort study aims to assess the impact of the introduction of CT-P13 on the healthcare expenditures of patients who were treated with originator infliximab or CT-P13. Methods Gastroenterology, immunoallergology and rheumatology patients treated between September 2017 and December 2020 at a university hospital in Western Switzerland were included and divided into seven cohorts, based on their treatment pathway (i.e., use and discontinuation of CT-P13 and/or originator infliximab). Costs in Swiss francs were obtained from the hospital's cost accounting department and length of stay was extracted from inpatient records. Comparisons of costs and length of stay between cohorts were calculated by bootstrapping. Results Sixty immunoallergology, 84 rheumatology and 114 gastroenterology patients were included. Inpatient and outpatient costs averaged (sd) CHF 1,611 (1,020) per hospital day and CHF 4,991 (6,931) per infusion, respectively. The mean (sd) length of stay was 20 (28) days. Although immunoallergology and rheumatology patients had higher average costs than gastroenterology patients, differences in costs and length of stay were not formally explained by treatment pathway. Differences in health resource utilization were marginal. Conclusions The introduction of CT-P13 and the disruption of patient treatment management were not associated with differences in average outpatient and inpatient costs and length of stay, in contrast to the results reported in the rest of the literature. Future research should focus on the cost-effectiveness of non-medical switching policies and the potential benefits for patients.

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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

Does the introduction of an infliximab biosimilar always result in savings for hospitals? A descriptive study using real-world data

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