Comparative efficacy and safety of infliximab biosimilar (BCD-055) and innovator infliximab in patients with ankylosing spondylitis (results of international, multiple-center, double-blind phase I and phase III clinical studies)

Каратеев, Дмитрий Евгеньевич; Мазуров, В. И.; Зонова, Е. В.; Несмеянова, О. Б.; Плаксина, Т. В.; Кречикова, Д. Г.; Reshetko, О.V.; Denisov, L.; Гордеев, И. Г.; Покровская, Т. Г.; Антипова, О. В.; Кропотина, Т. В.; Поварова, Т. В.; Шестерня, П. А.; Ушакова, Е. Н.; Soroka, N.; Пристром, А. М.; Eremeeva, A.; Черняева, Е. В.; Ivanov, Roman; Усачева, Ю. В.

doi:10.14412/1996-7012-2017-3-14-25

Cited by 5 publications

(1 citation statement)

References 23 publications

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“…Some biosimilars have been approved in Russia using a mainly generic approach [10,11,13]. However, recently, some biosimilars have been evaluated in comparative clinical trials with originator (reference) products [26,27,28]. It must be noted that at the time this survey was conducted, data were not available for some biosimilars that have now been approved in Russia (Table S1).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing

Karateev

Belokoneva

2019

Biomolecules

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Physician awareness and perceptions towards biosimilars are important factors in their adoption to clinical practice. Our objectives were to assess levels of knowledge and attitudes towards biosimilars and key policies on their use among Russian physicians, define the level of interest in new information on biosimilars, and determine what evidence drives treatment decisions in Russia. Physicians with awareness of biologics across different specialties and regions of Russia completed an online survey. A Likert and other rating scales were used to collect opinions, which were summarized descriptively. Responses of subgroups of respondents were compared using t-tests. Among 206 respondents (n = 51 rheumatologists; n = 53 gastroenterologists; n = 50 hematologists; n = 52 oncologists), 66% had positive impressions regarding the introduction of biosimilars in Russia. Overall, 80% lacked understanding of the differences between biosimilars and generics. In all, 67% supported prescribing biologics by distinguishable names and were negative about tender policies limiting choice of therapies for patients. The majority believed in mandatory publication of clinical trial results on biosimilars (94%), agreed biosimilars should be subject to rigorous post-marketing surveillance (98%), and expressed willingness to learn more about biosimilars (94%). Biosimilar education among Russian physicians is required, which may help shape balanced and evidence-based policies for biosimilars in Russia.

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Section: Introductionmentioning

confidence: 99%

Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing

Karateev

Belokoneva

2019

Biomolecules

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In Vitro Cell-Based Bioassays for Screening and Comparison of the TNFα and IL-17A Inhibitors

Ossina,

Pugachev,

Orlov

et al. 2023

Appl Biochem Microbiol

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Comparative Evaluation of the Long-Term Efficacy and Safety of the Infliximab Biosimilar BCD-055 and Reference Infliximab in Patients With Ankylosing Spondylitis: Results of the International Multicenter Randomized Double-Blind Phase Iii Clinical Study Asart-2

Лила¹,

Мазуров²,

Зонова³

et al. 2018

rsp

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The paper gives data on the clinical efficiency and safety profile of long-term use of the infliximab (INF) biosimilar BCD-055 versus the reference drug Remicade® (REM) in a population of patients with active ankylosing spondylitis (AS).Subjects and methods. An international multicenter randomized double-blind Phase III clinical trial was conducted in 199 patients who were randomized into two groups in a 2:1 ratio and who received BCD-055 or REM at a dose of 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Efficiency assessment was made at 14, 30 and 54 weeks in patients who received at least one dose of INF [intent-to-treat (ITT)], as well as at 54 weeks in those who completed the study according to the Protocol (PP) (per protocol). The efficiency endpoints were the proportion of patients who had achieved ASAS20/ASAS40 responses; changes in BASDAI, BASMI, BASFI, MASES, and SF-36 scores. Immunogenicity was assessed by the proportion of patients in each group with identified binding and neutralizing antibodies (BAbs and NAbs) against INF. The safety analysis included the overall rate of adverse events (AEs), including those that met the respective criteria for serous AEs (SAEs), and grade 3–4 toxicity, as well as the number of cases of early termination of the study because of AEs and SAEs.Results and discussion. The ITT population included 199 patients and the PP one consisted of 161 people. The groups were not statistically different in the rate of and reasons for patient withdrawal from the study. A comparable number of patients achieved ASAS20/ASAS40 responses at 14, 30, 54 weeks (р ≥ 0.05). At 54 week, the proportion of patients who received BCD-055 and REM therapy and achieved an ASAS20 response was 67.42 and 52.24% in the ITT population (p = 0.053) and 80.91 and 68.63% in the PP population (p = 0.128). The BCD-055 and drug comparison groups achieved an ASAS40 response in 53.03 and 38.81% in the ITT population (p = 0.081) and in 63.64 and 50.98% in the PP one (p = 0.177). The proportion of persons with identified BAbs and NAbs was comparable: 21.26 and 3.15% in the BCD-055 group (p = 0.920) and 20.63 and 6.35% in the group REM (p = 0.443), respectively. It was found that the presence of NAbs did not affect the therapeutic response. Both groups did not differ in the detection rate and profile of AEs and SAEs or in the rate of patient withdrawal due to AEs. Most identified AEs were mild to moderate.Conclusion. The efficacy of the INF biosimilar BCD-055 used long in patients with AS did not significantly differ from that of the original drug REM; the safety profile of both drugs was comparable.

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Comparative efficacy and safety of infliximab biosimilar (BCD-055) and innovator infliximab in patients with ankylosing spondylitis (results of international, multiple-center, double-blind phase I and phase III clinical studies)

Cited by 5 publications

References 23 publications

Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing

Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing

In Vitro Cell-Based Bioassays for Screening and Comparison of the TNFα and IL-17A Inhibitors

Comparative Evaluation of the Long-Term Efficacy and Safety of the Infliximab Biosimilar BCD-055 and Reference Infliximab in Patients With Ankylosing Spondylitis: Results of the International Multicenter Randomized Double-Blind Phase Iii Clinical Study Asart-2

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