DOP061 Phase III randomised, double-blind, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn's disease: early efficacy and safety results

Kim, Y.H.; Ye, B.D.; 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, Bogdan; Lee, K.M.; Eun, Chang Soo; Lee, S.J.; Lee, S.Y.

doi:10.1093/ecco-jcc/jjx002.098

Cited by 16 publications

(8 citation statements)

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“…Since biosimilars cannot be exact copies of the original molecule, there are lingering concerns about switching stable patients to a biosimilar when they are doing well on an originator. So far, only a few randomized studies have examined the impact of switching patients from stable originator treatment to a biosimilar . The NOR‐SWITCH study was the first randomized controlled trial examining switching from an originator product to a biosimilar in stable, long‐term infliximab‐treated patients .…”

Section: Introductionmentioning

confidence: 99%

Long‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: open‐label extension of the NOR‐SWITCH trial

et al. 2019

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Background and objectivesThe 52‐week, randomized, double‐blind, noninferiority, government‐funded NOR‐SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT‐P13 was not inferior to continued treatment with infliximab originator. The NOR‐SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT‐P13 throughout the 78‐week study period (maintenance group) versus patients switched to CT‐P13 at week 52 (switch group). The primary outcome was disease worsening during follow‐up based on disease‐specific composite measures.MethodsPatients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis.ResultsBaseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per‐protocol set). Adjusted risk difference was 5.9% (95% CI −1.1 to 12.9). Frequency of adverse events, anti‐drug antibodies, changes in generic disease variables and disease‐specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases.ConclusionThe NOR‐SWITCH extension showed no difference in safety and efficacy between patients who maintained CT‐P13 and patients who switched from originator infliximab to CT‐P13, supporting that switching from originator infliximab to CT‐P13 is safe and efficacious.

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Section: Introductionmentioning

confidence: 99%

Long‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: open‐label extension of the NOR‐SWITCH trial

et al. 2019

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“…For example, a randomized Phase III study was planned to compare the use of CT-P13 and reference infliximab in patients with active Crohn's disease. The first available data from this study, which showed that the efficacy and safety of CT-P13 and its reference product were similar up to week 6 of treatment, have recently been presented at a large European congress on IBD [51]. The European pharmacovigilance program for CT-P13 also includes postmarketing registries that are collecting data on the 'real-life' safety and efficacy of CT-P13 in patients in the clinic, including those with RA or IBD, up to the year 2026 [50].…”

Section: • Continued Data Collectionmentioning

confidence: 88%

Looking to the future and learning lessons from the recent past: changing stakeholder perceptions of biosimilars in cancer

2017

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As the patents for many biologic anticancer drugs expire, significant growth in the use of biosimilars is predicted, offering an opportunity to help combat the rising costs of treatment and increase patient access to biologic therapy. Attainment of regulatory approval, involving numerous nonclinical and clinical comparative studies versus each reference product, is only one of several barriers to realize the potential gains offered by biosimilars. It is important to understand the current perceptions and informational needs of different stakeholders if biosimilars are to be accepted and widely used in the clinic. We discuss these considerations and refer to recent experiences with CT-P13, a biosimilar of the TNF inhibitor infliximab used to treat rheumatoid arthritis and other inflammatory disorders.

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“…Non-inferiority of the biosimilar to the originator infliximab was demonstrated in a phase III trial for rheumatoid arthritis [8] and extrapolation assumes equivalence in efficacy for Crohn's disease. Results from a post-marketing trial of Inflectra and Remicade indicate there is no significant difference between the efficacy and safety of the two drugs at 6 weeks [56]. Observational studies and clinical case series have confirmed that Inflectra appears to be safe and efficacious, especially in infliximabnaïve patients [57].…”

Section: Discussionmentioning

confidence: 99%

Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn’s Disease

et al. 2019

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Aim: Regulatory approval of biosimilars often depends on extrapolating evidence from one clinical indication to all of those of the originator biologic. We aimed to develop a quantitative benefit-risk analysis to assess whether the resulting increase in the uncertainty in the clinical performance of biosimilars (i.e. risk) may be countered by their lower pricing (benefit). Methods: A one-year decision-analytic model was developed for the biosimilar infliximab (Inflectra®) for Crohn's disease. The perspective was that of the NHS in the UK and costs were valued to 2015/16. A hypothetical cohort of biologic-naïve patients with moderate-to-severe Crohn's disease were simulated through the model. Immunogenicity to infliximab was a key modifier, influencing rates of non-response and infusion reactions. Net health benefit was estimated based on quality-adjusted life years (QALYs). A range of sensitivity analyses tested the robustness of the results and explored how the biosimilar price must respond to varying immunogenicity to remain the preferred option. Results: The base-case analysis predicted a positive incremental net health benefit of 0.04 (95% Central Range 0.00-0.09) favouring the biosimilar, based on 0.803 QALYs, and costs of £18,087 and £19,176 for biosimilar and originator, respectively. Two-way sensitivity analyses suggested that if 50% of patients developed antibodies, the value-based price of £410 per vial must be lower than that of the originator (£420), but remain higher than the actual market price (£378). Conclusions: The model supports the use of Inflecta® for Crohn's disease in the UK, and provides a framework for the quantitative evaluation of biosimilars in the context of health technology assessment. Value-based pricing using this methodology could protect health systems from the potential risks of biosimilars where they are untested in the approved populations. Key points for decision makers  The base-case analysis predicts a positive incremental net health benefit of 0.04 (95% Central Range 0.00-0.09) favouring the biosimilar and suggests that if 50% of patients developed antibodies, the value-based price would need to be below the originator but higher than the current market price.  The study presents a novel framework for the quantitative benefit-risk assessment of biosimilars, illustrated with biosimilar infliximab for Crohn's disease  The methods provide an explicit framework for balancing risks (the uncertainty in the efficacy and harms of biosimilars) against their benefits (cost advantages)

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DOP061 Phase III randomised, double-blind, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn's disease: early efficacy and safety results

Cited by 16 publications

References 0 publications

Long‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: open‐label extension of the NOR‐SWITCH trial

Long‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: open‐label extension of the NOR‐SWITCH trial

Looking to the future and learning lessons from the recent past: changing stakeholder perceptions of biosimilars in cancer

Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn’s Disease

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