Biosimilars Have Arrived: Rituximab

Greenwald, Maria; Tesser, John; Sewell, K. Lea

doi:10.1155/2018/3762864

Cited by 35 publications

(22 citation statements)

References 27 publications

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“…The Rituximab biosimilar, Truxima, has now been investigated in non-Hodgkin Lymphoma and rheumatoid arthritis and has now been approved for their treatment in Europe (Kim et al, 2017;Suh et al, 2017;Greenwald et al, 2018). Truxima has been shown to have similar pharmacokinetics, efficacy and immunogenicity to the originator (Coiffier, 2017).…”

Section: Discussionmentioning

confidence: 99%

Comparison of Rituximab originator (MabThera) to biosimilar (Truxima) in patients with immune‐mediated thrombotic thrombocytopenic purpura

Stubbs¹,

Low²,

McGuckin³

et al. 2019

Br J Haematol

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Summary Immune thrombotic thrombocytopenic purpura (iTTP) is an acute, multisystem thrombotic microangiopathy mediated by ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) autoantibodies. Immunosuppression with anti‐CD20 therapy is the mainstay of treatment. MabThera's patent has now expired and biosimilars have been approved. Eighty‐four consecutive patient episodes over 2 years, prior to and following our switch to Truxima are presented. Day 1 (D1), Day 28 (D28) and 3‐month platelet counts, ADAMTS13 activity, and CD19 levels, adverse reactions and infective complications were recorded. Platelet counts were not significantly different between acute MabThera and Truxima treatment (D1 P = 0.085, D28 P = 0.77, 3 months P = 0.71) and electively (D1 P = 0.79, D28 P = 0.68, 3 months P = 0.99). ADAMTS13 recovery also was not significantly different acutely (D1 P = 0.99, D28 P = 0.27, 3 months P = 0.26) and electively (D1 P = 0.59, D28 P = 0.61, 3 months P = 0.34). CD19% depletion at D1 and 3 months was not significantly different acutely (D1 P = 0.52, 3 months P = 0.56) and electively (D1 P = 0.22, 3 months P = 0.19). Infusion reactions and infective complications were comparable with both therapies. This is the first series of the Rituximab biosimilar Truxima to be reported in iTTP, demonstrating equivalence to MabThera in terms of ADAMTS13 recovery, CD19 depletion, and platelet count at D28 and 3 months post‐administration, with comparable infusion and infective complications. The financial benefit of the biosimilar anti‐CD20 is considerable.

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Section: Discussionmentioning

confidence: 99%

Comparison of Rituximab originator (MabThera) to biosimilar (Truxima) in patients with immune‐mediated thrombotic thrombocytopenic purpura

Stubbs¹,

Low²,

McGuckin³

et al. 2019

Br J Haematol

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“…Results: There were two groups of patients with AH diagnosed on clinical data: group 1 (with AH) -244 (85%) pts, group 2 (without AH) -42 (15%) pts. 4]mg/l, accordingly, p<0.05. We didn't find differences of lipid profile, serum uric acid, and serum creatinine level in 1 and 2 group.…”

mentioning

confidence: 83%

Ab0110 rituximab Induced Granulomatous Hepatitis With a Sarcoidosis Like Reaction: A Blinded Trial in Mice

Al-Mogairen

Alhumaidi

2019

Abstracts Accepted for Publication

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BackgroundRituximab is useful in patients with rheumatoid arthritis (RA) with persistently active disease despite adequate trials with other disease-modifying antirheumatic drugs (DMARDs).ObjectivesTo determine whether the inhibition of the B cell CD20 receptor by rituximab results in acute hepatitis in BALB/c mice.MethodsTwenty BALB/c mice were studied. Ten mice received subcutaneous (SC) injection of rituximab (0.31mg per 25g body weight per 0.03 ml normal saline) at 0, 1, 2 and 4 weeks. For the control group, 10 mice received a SC injection of normal saline (NS) (0.03 ml). At the 10th week post injection, the mice were sacrificed, and histopathological studies were conductedResultsOf the rituximab-treated group, 1/10 mice died. Liver histology for the rituximab -treated group showed that 7/9 displayed histopathological changes in the lobular cellular infiltrates of eosinophils, lymphocytes and histocytes, in addition to granuloma formation. In contrast, only minimal inflammation was observed in 3/10 mice in the control group (p=0.051).ConclusionTo our knowledge this is the first experimental controlled study demonstrating rituximab may play a role in inducing granulomatous hepatitis with a sarcoidosis-like reaction.References[1] Soliman MM, Hyrich KL, Lunt M, Watson KD, Symmons DP, Ashcroft DM. Rituximab or a second anti-tumor necrosis factor therapy for rheumatoid arthritis patients who have failed their first anti-tumor necrosis factor therapy? Comparative analysis from the British Society for Rheumatology Biologics Register. Arthritis Care Res (Hoboken)2012;64:1108-15.[2] Reuben A. Hepatotoxicity of immunosuppressive drugs. In:Kaplowitz N, DeLeve LD, eds.Drug-induced liver disease. 3rd ed.Amsterdam: Elsevier;2011:569-91.[3] Nard FD, Todoerti M, Grosso V, Monti S, Breda S, Rossi S, et al. Risk of hepatitis B virus reactivation in rheumatoid arthritis patients undergoing biologic treatment: Extending perspective from old to newer drugs. World J Hepatol2015;7:344-361.[4] Greenwald M, Tesser J, Sewell KL. Biosimilars Have Arrived: Rituximab. Arthritis2018;2018.Disclosure of InterestsNone declared

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“…Снижение стоимости лечения дорогостоящими ГИБП и, как следствие, увеличение доступности инновационной терапии у пациентов, живущих в странах с ограниченными экономическими ресурсами, является при- оритетной задачей здравоохранения всех стран мира. Эта проблема частично решена благодаря разработке биоаналогов (biosimilars) ГИБП, широкое применение которых в клинической практике стало возможным благодаря окончанию срока действия патентов для многих оригинальных ГИБП [335][336][337][338][339], включая РТМ [340][341][342][343] В 2001 г. в России была основана биотехнологическая компания «БИОКАД», занимающаяся производством биоаналогов и оригинальных ГИБП. В настоящее время на разных стадиях разработки находятся ряд ГИБП, предназначенных для лечения аутоиммунных заболеваний, включая РТМ [344] Хотя бы одна НЛР / серьезная НЛР (СНЛР) была зарегистрирована у 48 (44,9%) пациентов в группе Ацеллбия ® + МТ и у 22 (43,1%) в группе ПЛ + МТ (р=0,974).…”

Section: биоаналоги ритуксимабаunclassified