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A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study

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Abstract

BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [− 7.0%; 13.5%] (р = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 response at all timepoints without significant differences (p > 0.05). The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111). Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm (p = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study.

Trial registration ClinicalTrials.gov ID, number NCT02762838.

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Acknowledgements

The authors appreciate Nikita Zolkin and Ivan Kuryshev (JSC BIOCAD, Russia) for statistical analysis, and support in manuscript development. Employees of JSC BIOCAD, the study sponsor, designed the study in collaboration with the academic authors, conducted the study, collected the data, performed statistical analyses, and were involved in the writing of the study manuscript. Contributing centers (principal investigators)—Russia: Olga V. Antipova, Anna N. Galustyan, Ivan G. Gordeev, Antonina F. Davidova, Natalya A. Eremina, Alexander A. Kastanyan, Larisa A. Knayzeva, Tatyana V. Kropotina, Irina M. Marusenko, Irina M. Patrikeeva, Tatyana V. Plaksina, Tatyana V. Povarova, Tatyana G. Pokrovskaya, Olga V. Reshetko, Elena A. Smolyarchuk, Irina A. Shumichina, Elena V. Zemerova, Elena V. Zonova, Eduard A. Ponomarev, Svetlana A. Smakotina, Marianna S. Petrova, Galina A. Chumakova, Larisa V. Eliseeva, Maria I. Skalinskaya. Belarus: Igor E. Adzericho, Sergey I. Pimanov, Andrey M. Pristom, Elena V. Kunder, Nikolay F. Soroka. India: Reema Kashiva, Ajit Bapurao Nalawade, Liyakat Ali Gauri, Vishnu Sharma, Syamasis Bandyopadhyay, Bindumathi P. L.

Funding

This study was sponsored by JSC BIOCAD.

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Authors and Affiliations

  1. North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg, Russia

    Alexander M. Lila & Vadim I. Mazurov

  2. V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia

    Alexander M. Lila & Lev N. Denisov

  3. State Budgetary Institution of Healthcare “Chelyabinsk Regional Clinical Hospital”, Chelyabinsk, Russia

    Olga B. Nesmeyanova

  4. State Budgetary Institution of Healthcare “Leningrad Region Clinical Hospital”, Saint Petersburg, Russia

    Elena P. Ilivanova

  5. JSC BIOCAD, Saint Petersburg, Russia

    Anna V. Eremeeva, Julia Valentinovna Usacheva, Ekaterina A. Dokukina, Ekaterina V. Chernyaeva & Roman A. Ivanov

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  1. Alexander M. Lila
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  2. Vadim I. Mazurov
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  3. Lev N. Denisov
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In accordance with ICMJE criteria, all authors were involved in writing and drafting the article or revising it critically for important intellectual content. All authors approved the final version to be submitted for publication and agree to be accountable for all aspects of the work.

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Correspondence to Julia Valentinovna Usacheva.

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Conflict of interest

Alexander M. Lila, Vadim I. Mazurov, Lev N. Denisov, Olga B. Nesmeyanova, Elena P. Ilivanova declare that they have no conflict of interest. Anna V. Eremeeva, Julia V. Usacheva, Ekaterina V. Chernyaeva, Ekaterina A. Dokukina and Roman A. Ivanov Employees of JCS BIOCAD.

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All patients were informed, and their informed consents were obtained prior to the study. The information on all Ethics Committees and approval dates is presented in Supplementary Material B.

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Lila, A.M., Mazurov, V.I., Denisov, L.N. et al. A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study. Rheumatol Int 39, 1537–1546 (2019). https://doi.org/10.1007/s00296-019-04359-9

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