THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA®) IN RHEUMATOID ARTHRITIS (THE BIORA STUDY)
The article considers the results of an international multicenter randomized clinical trial of the efficacy and safety of the brand-name drug rituximab (MabThera), a monoclonal antibody against CD20 antigen of B cells, and its biosimi-lar drug (Acellbia®) (the BIORA study) in patients with rheumatoi...
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IMA PRESS LLC
2016-12-01
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| Series: | Научно-практическая ревматология |
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| Online Access: | https://rsp.mediar-press.net/rsp/article/view/2292 |
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| author | E. L. Nasonov E. V. Zonova O. N. Ivanova L. A. Knyazeva V. I. Mazurov R. R. Samigullina I. M. Marusenko O. B. Nesmeyanova T. V. Plaksina A. E. Sizikov D. G. Krechikova N. A. Petrochenkova Yu. S. Shapovalova N. S. Soroka S. I. Pimanov A. M. Pristrom E. V. Kunder E. V. Chernyaeva A. V. Eremeeva R. Ivanov |
| author_facet | E. L. Nasonov E. V. Zonova O. N. Ivanova L. A. Knyazeva V. I. Mazurov R. R. Samigullina I. M. Marusenko O. B. Nesmeyanova T. V. Plaksina A. E. Sizikov D. G. Krechikova N. A. Petrochenkova Yu. S. Shapovalova N. S. Soroka S. I. Pimanov A. M. Pristrom E. V. Kunder E. V. Chernyaeva A. V. Eremeeva R. Ivanov |
| author_sort | E. L. Nasonov |
| collection | DOAJ |
| description | The article considers the results of an international multicenter randomized clinical trial of the efficacy and safety of the brand-name drug rituximab (MabThera), a monoclonal antibody against CD20 antigen of B cells, and its biosimi-lar drug (Acellbia®) (the BIORA study) in patients with rheumatoid arthritis (RA) refractory to therapy with tumor necrosis factor-а inhibitors.Objective: to provide evidence for the therapeutic equivalence of Acellbia® and MabThera® and also to assess their interchangeability.Subjects and methods. The trial enrolled adult patients with active seropositive RA, who were randomized into two groups (1:1): 1) the patients who received Acellbia® 1000 mg intravenously on days 1 and 15; 2) those who had MabThera® in a similar way. When RA activity persisted at 24 weeks, there was re-randomization (1:1) with a partial overlap: Group 1 patients were randomized into group AA (the drug of the second therapy cycle was Acellbia®) or Group AM (that was MabThera®), the similar methodology was followed in Group 2 (Groups MM and MA). Throughout the study, the patients received methotrexate at a stable dose of 7.5—25 mg/week and folic acid at a dose of 5 mg/week. The follow-up lasted 48 weeks.Results and discussion. 24 weeks after treatment initiation, the ACR20 response was observed in 84.1% of the patients in the Acellbia® group (95% CI, 74.75—90.50) and in 87% in the MabThera® group (95% CI, 77.71—92.79%; p = 0.773), which suggests that the drugs are therapeutically equivalent. In the second phase of the study, the efficiency of therapy remained high; there were no differences in Groups AA/MM, AA/AM and MM/MA. In both phases, the safety profile of the drugs was comparable; the immunogenicity of treatment remained low. The findings suggest that the brand-name MabThera® and its biosimilar drug Acellbia® are equivalent. Switching from the biosimilar drug to the brand-name one and vice versa has no negative impact on treatment outcomes. |
| first_indexed | 2024-04-09T22:23:41Z |
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| institution | Directory Open Access Journal |
| issn | 1995-4484 1995-4492 |
| language | Russian |
| last_indexed | 2025-03-14T08:05:36Z |
| publishDate | 2016-12-01 |
| publisher | IMA PRESS LLC |
| record_format | Article |
| series | Научно-практическая ревматология |
| spelling | doaj.art-1851db3d61f34b5b9904808e9377604d2025-03-02T13:23:43ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922016-12-0154551051910.14412/1995-4484-2016-510-5192154THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA®) IN RHEUMATOID ARTHRITIS (THE BIORA STUDY)E. L. Nasonov0E. V. Zonova1O. N. Ivanova2L. A. Knyazeva3V. I. Mazurov4R. R. Samigullina5I. M. Marusenko6O. B. Nesmeyanova7T. V. Plaksina8A. E. Sizikov9D. G. Krechikova10N. A. Petrochenkova11Yu. S. Shapovalova12N. S. Soroka13S. I. Pimanov14A. M. Pristrom15E. V. Kunder16E. V. Chernyaeva17A. V. Eremeeva18R. Ivanov19V.A. Nasonova Research Institute of Rheumatology; Institute of Professional Education, I.M. Sechenov First Moscow State Medical UniversityCity Clinical Polyclinic OneVoronezh Regional Clinical Hospital OneKursk Regional Clinical HospitalI.I. Mechnikov North-Western State Medical UniversityI.I. Mechnikov North-Western State Medical UniversityV.A. Baranov Republican HospitalChelyabinsk Regional Clinical HospitalN.A. Semashko Nizhny Novgorod Regional Clinical HospitalResearch Institute of Fundamental and Clinical Immunology, Siberian Branch, Russian Academy of SciencesSectional Hospital at the Smolensk Station, RZhD, OAOSmolensk State Medical UniversityRailway Clinical Hospital at the Chelyabinsk Station, RZhD, OAOCity Clinical Hospital NineVitebsk Regional Clinical HospitalCity Clinical Hospital OneCity Clinical Hospital OneBIOKAD, ZAOBIOKAD, ZAOBIOKAD, ZAOThe article considers the results of an international multicenter randomized clinical trial of the efficacy and safety of the brand-name drug rituximab (MabThera), a monoclonal antibody against CD20 antigen of B cells, and its biosimi-lar drug (Acellbia®) (the BIORA study) in patients with rheumatoid arthritis (RA) refractory to therapy with tumor necrosis factor-а inhibitors.Objective: to provide evidence for the therapeutic equivalence of Acellbia® and MabThera® and also to assess their interchangeability.Subjects and methods. The trial enrolled adult patients with active seropositive RA, who were randomized into two groups (1:1): 1) the patients who received Acellbia® 1000 mg intravenously on days 1 and 15; 2) those who had MabThera® in a similar way. When RA activity persisted at 24 weeks, there was re-randomization (1:1) with a partial overlap: Group 1 patients were randomized into group AA (the drug of the second therapy cycle was Acellbia®) or Group AM (that was MabThera®), the similar methodology was followed in Group 2 (Groups MM and MA). Throughout the study, the patients received methotrexate at a stable dose of 7.5—25 mg/week and folic acid at a dose of 5 mg/week. The follow-up lasted 48 weeks.Results and discussion. 24 weeks after treatment initiation, the ACR20 response was observed in 84.1% of the patients in the Acellbia® group (95% CI, 74.75—90.50) and in 87% in the MabThera® group (95% CI, 77.71—92.79%; p = 0.773), which suggests that the drugs are therapeutically equivalent. In the second phase of the study, the efficiency of therapy remained high; there were no differences in Groups AA/MM, AA/AM and MM/MA. In both phases, the safety profile of the drugs was comparable; the immunogenicity of treatment remained low. The findings suggest that the brand-name MabThera® and its biosimilar drug Acellbia® are equivalent. Switching from the biosimilar drug to the brand-name one and vice versa has no negative impact on treatment outcomes.https://rsp.mediar-press.net/rsp/article/view/2292rheumatoid arthritisrituximabbiosimilar drug |
| spellingShingle | E. L. Nasonov E. V. Zonova O. N. Ivanova L. A. Knyazeva V. I. Mazurov R. R. Samigullina I. M. Marusenko O. B. Nesmeyanova T. V. Plaksina A. E. Sizikov D. G. Krechikova N. A. Petrochenkova Yu. S. Shapovalova N. S. Soroka S. I. Pimanov A. M. Pristrom E. V. Kunder E. V. Chernyaeva A. V. Eremeeva R. Ivanov THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA®) IN RHEUMATOID ARTHRITIS (THE BIORA STUDY) Научно-практическая ревматология rheumatoid arthritis rituximab biosimilar drug |
| title | THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA®) IN RHEUMATOID ARTHRITIS (THE BIORA STUDY) |
| title_full | THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA®) IN RHEUMATOID ARTHRITIS (THE BIORA STUDY) |
| title_fullStr | THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA®) IN RHEUMATOID ARTHRITIS (THE BIORA STUDY) |
| title_full_unstemmed | THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA®) IN RHEUMATOID ARTHRITIS (THE BIORA STUDY) |
| title_short | THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA®) IN RHEUMATOID ARTHRITIS (THE BIORA STUDY) |
| title_sort | results of a phase iii comparative clinical trial of rituximab acellbia r and mabthera r in rheumatoid arthritis the biora study |
| topic | rheumatoid arthritis rituximab biosimilar drug |
| url | https://rsp.mediar-press.net/rsp/article/view/2292 |
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