Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis

The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.

开始日期2015-01-01

申办/合作机构

Biocad CJSC

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项与利妥昔单抗生物类似药(Biocad Medical, Inc.) 相关的文献（医药）

2024-08-01·Doklady Biochemistry and Biophysics

The Use of “Acellbia”—A Biosimilar of Rituximab in Systemic Sclerosis

Article

作者: Garzanova, L A ; Nasonov, E L ; Koneva, O A ; Glukhova, S I ; Ovsyannikova, O B ; Starovoitova, M N ; Shayakhmetova, R U ; Ananyeva, L P ; Desinova, O V

The possibilities of modern therapy for systemic sclerosis (SSc) remains limited, since most of the used drugs do not have a disease-modifying effect. This encourages the study of new approaches that potentially affect the fundamental pathological processes underlying the disease. One example is anti-B-cell therapy, in particular rituximab (RTX). Until now RTX does not have a registration for the treatment of SSc, but there is a large positive experience of its use, which is reflected in recent meta-analyses and clinical recommendations. Complicated and expensive methods for obtaining genetically engineered biological drugs (biologics) have contributed to the emergence of more accessible biosimilars, one of which is the RTX biosimilar, Acellbia (Biocad, Russian Federation). The ''biosimilar'' versions of RTX might reduce the cost of therapy and increase patients accessibility to this treatment option. The RTX biosimilar Acellbia (ACB) has received approval in Russian Federation in 2014 for all indications held by reference RTX (including rheumatoid arthritis and ANCA-associated vasculitis).

2023-05-22·Biomedicines

Rituximab Biosimilar BCD020 Shows Superior Efficacy above Conventional Non-Biologics Treatment in Pediatric Lupus Nephritis: The Data of Retrospective Cohort Study.

Article

作者: Kalashnikova, Elvira ; Snegireva, Ludmila ; Masalova, Vera ; Suspitsin, Evgeny ; Chasnyk, Vyacheslav ; Abramova, Natalia ; Kalashnikova, Olga ; Kuchuinskaya, Ekaterina ; Gaidar, Ekaterina ; Kaneva, Maria ; Sorokina, Lubov ; Lubimova, Natalia ; Dubko, Margarita F ; Kostik, Mikhail ; Kornishina, Tatyana ; Isupova, Eugenia ; Rinat, Raupov ; Soloviev, Anton A

BACKGROUNDPediatric lupus nephritis (LN) is one of the most serious manifestations of systemic lupus erythematosus (SLE) in children, determining the outcomes of the disease. There are no standardized treatment protocols for pediatric LN, and the role of biologics has not yet been conclusively defined.OBJECTIVESanalyze the safety and efficacy of rituximab biosimilar BCD020 in pediatric patients with lupus nephritis.METHODSin a retrospective cohort study, the data from the case histories of 25 patients with LN (10 boys and 15 girls) with an onset age of 13 (9-16) years, who failed conventional non-biologic treatment or developed corticosteroid dependence/toxicity, were included. The diagnosis was made using Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. Rituximab biosimilar BCD020 was prescribed in a dosage of 375 mg/m² every week (2-4 infusions) with repeated courses every 6-12 months (2-4 infusions) according to disease activity, B-cell depletion, and IgG levels. The dynamics of clinical and laboratory data, the activity of the disease by SLEDAI, and corticosteroid doses were assessed at the onset and during the rituximab trial.RESULTSThe main patient's characteristics were: Pre-rituximab non-biologic conventional treatment included: cyclophosphamide 15 (60%), MMF 8 (32%), azathioprine 3 (12%), hydroxychloroquine 12 (48%), and pulse therapy of methylprednisolone followed by oral methylprednisolone 25 (100%). The time before rituximab was 7.0 (3.0-24.0) months, and the whole observation period was 7.0 (0; 24) months. The initial pre-rituximab treatment slightly reduced SLEDAI levels and the proportion of patients with LN. A significant reduction of SLEDAI, the anti-dsDNA level, proteinuria, hematuria, C4 complement, ESR, and the median corticosteroid dose by 80% from the initial value, as well as the proportion of patients without corticosteroids, was observed after rituximab administration. Two deaths were observed due to catastrophic SLE with macrophage activation syndrome, accompanied by a severe infection (invasive aspergillosis, n = 2). Three patients developed serious adverse events: pneumonia (n = 2), transient agranulocytosis (n = 1) after the third rituximab infusion, and meningitis, caused by Listeria monocytosis, after the first rituximab infusion. Eight patients received antibacterial treatment for different respiratory infections without hospital admissions.CONCLUSIONSRituximab biosimilar BCD020 showed effectiveness in LN, whereas previous non-biologic treatment was insufficiently effective. Randomized controlled trials are required to evaluate the efficacy and safety of rituximab and evaluate the benefits when compared with conventional SLE treatment.

2020-02-01·Hematological Oncology3区 · 医学

Proposed rituximab biosimilar BCD‐020 versus reference rituximab for treatment of patients with indolent non‐Hodgkin lymphomas: An international multicenter randomized trial

3区 · 医学

Article

作者: Ivanov, Roman A. ; Bermúdez, Carlos D. ; Attili, V. Satya Suresh ; Poddubnaya, Irina V. ; Rekhtman, Grigoriy B. ; Chernyaeva, Ekaterina V. ; Lukavetskyy, Les M. ; Kaplanov, Kamil D. ; Alekseev, Sergey M. ; Isaev, Aleksandr A. ; Dolai, Tuphan K.

AbstractBCD‐020 is a proposed rituximab biosimilar, which has shown high similarity to rituximab in quality and nonclinical studies in vitro and in vivo.International multicenter clinical trial was conducted to compare efficacy and safety of BCD‐020 and reference rituximab in adult (older than 18 years) patients with indolent lymphomas (follicular lymphoma grade 1‐2, splenic marginal zone lymphoma, and nodal marginal zone lymphoma). Pharmacokinetics, pharmacodynamics, and immunogenicity were also studied.Patients with no previous biologic treatment for lymphoma were randomly assigned 1:1 to receive BCD‐020 or comparator 375 mg/m2 for 4 weeks.Primary study outcome was day 50 overall response rate defined as complete or partial remission. Equivalence range was −20% to 20% for 95% CI for overall response rates difference. Secondary outcomes included adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity.One hundred seventy‐four patients were enrolled, 89 in BCD‐020 arm and 85 in comparator arm. The overall response rate was 44.71% in BCD‐020 arm and 41.89% in comparator arm. Limits of 95% confidence interval (CI) for difference of overall response rates between arms were (−12.62%‐18.24%) showing equivalent efficacy. Sixty‐one (68.54%) and 59 (69.41%) patients had at least one adverse event in BCD‐020 arm or comparator arm, respectively. No unexpected adverse reactions were reported.Antidrug antibodies with no neutralizing activity were detected in two patients in comparator arm on day 14 further declining below detection threshold.Rituximab concentrations had equivalent pattern after intravenous administration of both drugs. Both drugs caused depletion of B‐cells without significant influence on other blood cell lineages.In this study, we showed equivalent efficacy of BCD‐020 and reference rituximab when used in patients with CD20‐positive indolent lymphomas. We also confirmed pharmacokinetic equivalence of BCD‐020 and reference rituximab. Safety profile, pharmacodynamics, and immunogenicity of BCD‐020 were also comparable with those of reference rituximab.

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC02	-

研发状态

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适应症	国家/地区	公司	日期
慢性淋巴细胞白血病	俄罗斯	Biocad Medical, Inc.	2015-01-01
非霍奇金淋巴瘤	俄罗斯	Biocad Medical, Inc.	2015-01-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2022	N/A	系统性硬化相关的间质性肺病	62	Mabthera	(糧膚鹽餘膚夢齋鹽艱製) = 鏇觸範壓鏇願獵壓鹽衊獵觸鬱鹽範襯簾衊衊夢 (鏇築鏇齋觸夢觸選壓築, 67.5[42.5 ~ 10 to 91]) 更多	-	2022-06-01
				Acellbia	(糧膚鹽餘膚夢齋鹽艱製) = 鏇築積鏇鹹網壓醖餘積獵觸鬱鹽範襯簾衊衊夢 (鏇築鏇齋觸夢觸選壓築, 42.6[52.5 ~ 13 to 90]) 更多
EULAR2016	临床3期	类风湿关节炎	160	BCD-020	(廠齋顧選構積選遞簾夢) = 膚遞膚簾鑰築淵淵觸遞鏇鑰製糧鏇願鏇獵壓餘 (選獵鏇廠製齋窪顧糧鑰 )	-	2016-06-08
				Innovator RTX	(廠齋顧選構積選遞簾夢) = 獵衊淵選積窪夢淵獵顧鏇鑰製糧鏇願鏇獵壓餘 (選獵鏇廠製齋窪顧糧鑰 )