The role of laboratory biomarkers in monitoring of rituximab biosimilar therapy (Acellbia, “BIOCAD”) in patients with rheumatoid arthritis
- Authors: Avdeeva AS1, Cherkasova MV1, Kusevich DA2, Rybakova VV2, Artyuhov AS3,4, Dashinimaev E.B3,4, Chichasova NV1,2, Nasonov EL1,2
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Affiliations:
- V.A. Nasonova Scientific and Research Institute of Rheumatology
- I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)
- Department of Regenerative Medicine
- Institute of Developmental Biology, Russian Academy of Sciences, Laboratory of Cell Proliferation, Pirogov Russian National Research Medical University
- Issue: Vol 91, No 5 (2019)
- Pages: 26-33
- Section: Editorial
- URL: https://journals.rcsi.science/0040-3660/article/view/33578
- DOI: https://doi.org/10.26442/00403660.2019.05.000230
- ID: 33578
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##article.viewOnOriginalSite##About the authors
A S Avdeeva
V.A. Nasonova Scientific and Research Institute of Rheumatology
Email: 9056249400@mail.ru
с.н.с. лаб. ранних артритов ФГБНУ «НИИР им. В.А. Насоновой» Moscow, Russia
M V Cherkasova
V.A. Nasonova Scientific and Research Institute of Rheumatologyн.с. лаб. иммунологии и молекулярной биологии ревматических заболеваний ФГБНУ «НИИР им. В.А. Насоновой» Moscow, Russia
D A Kusevich
I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)м.н.с. лаб. остеоартрита, аспирант каф. внутренних профессиональных болезней и ревматологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России Moscow, Russia
V V Rybakova
I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)аспирант каф. внутренних профессиональных болезней и ревматологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России Moscow, Russia
A S Artyuhov
Department of Regenerative Medicine; Institute of Developmental Biology, Russian Academy of Sciences, Laboratory of Cell Proliferation, Pirogov Russian National Research Medical Universityм.н.с. отд. регенеративной медицины НИИ трансляционной медицины РНИМУ им. Н.И. Пирогова Moscow, Russia
Eh B Dashinimaev
Department of Regenerative Medicine; Institute of Developmental Biology, Russian Academy of Sciences, Laboratory of Cell Proliferation, Pirogov Russian National Research Medical Universityс.н.с. лаб. клеточной биологии ИБР РАН им. Н.К. Кольцова; н.с. отд. регенеративной медицины НИИ трансляционной медицины РНИМУ им. Н.И. Пирогова Moscow, Russia
N V Chichasova
V.A. Nasonova Scientific and Research Institute of Rheumatology; I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)старший преподаватель отд. ординатуры и аспирантуры ФГБНУ «НИИР им. В.А. Насоновой»; проф. каф. ревматологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России Moscow, Russia
E L Nasonov
V.A. Nasonova Scientific and Research Institute of Rheumatology; I.M. Sechenov First Moscow State Medical University of Ministry of Health of the Russian Federation (Sechenov University)акад. РАН, д.м.н., проф., научный руководитель ФГБНУ «НИИР им. В.А. Насоновой»; зав. каф. ревматологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России Moscow, Russia
References
- Насонов Е.Л., Каратеев Д.Е., Балабанова Р.М. Ревматоидный артрит. В кн.: Ревматология. Национальное руководство. Под ред. Е.Л. Насонова, В.А. Насоновой. М.: ГЭОТАР-Медиа, 2008: 290-331.
- Насонов Е.Л. Ритуксимаб. В кн.: Генно - инженерные биологические препараты в лечении ревматоидного артрита. Под ред. Е.Л. Насонова. М.: ИМА-ПРЕСС, 2013:200-221.
- Huscher D, Mittendorf T, von Hinuber U, et al. Evolution of cost structures in rheumatoid arthritis over the past decade. Ann Rheum Dis. 2015;74(4):738-45. doi.org/10.1136/annrheumdis-2013-204311
- Насонов Е.Л. Биоаналоги в ревматологии. Научно - практическая ревматология. 2016;54(6):628-40. doi: 10.14412/1995-4484-2016-628-640
- Федеральный закон от 22 декабря 2014 г. №429-ФЗ «О внесении изменений в Федеральный закон "Об обращении лекарственных средств"». Принят Государственной Думой 9 декабря 2014 г. Одобрен Советом Федерации 17 декабря 2014 г.
- Yoo D.H, Suh C.H, Shim S.C, Jeka S, Molina F.F.C, Hrycaj P, Wiland P, Lee E.Y, Medina-Rodriguez F.G, Shesternya P, Radominski S, Stanislav M, et all. Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial. Bio Drugs. 2017 Aug;31(4):357-67. doi: 10.1007/s40259-017-0232-7
- Park W, Suh C.H, Shim S.C, et al. Efficacy and safety of switching from innovator rituximab to biosimilar CT-P10 compared with continued treatment with CT-P10: results of a 56-week open - label study in patients with rheumatoid arthritis. Bio Drugs. 2017 Jun 9; doi: 10.1007/s40259-017-0233-6 [Epub ahead of print]
- Yoo D.H, Suh C.H, Shim S.C, Jeka S, Cons-Molina F.F, Hrycaj P, Wiland P, Lee E.Y, Medina-Rodriguez F.G, Shesternya P, Radominski S, Stanislav M, Kovalenko V, Sheen D.H, Myasoutova L, Lim M.J, Choe J.Y, Lee S.J, Lee S.Y, Kwon T.S, Park W. A multicentrerandomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Mar;76(3):566-70. doi: 10.1136/annrheumdis-2016-209540 Epub 2016 Sep 13.
- Насонов Е.Л., Зонова Е.В., Иванова О.Н., Князева Л.А., Мазуров В.И. и др. Результаты сравнительного клинического исследования III фазы препаратов ритуксимаб (Ацеллбия и Мабтера) при ревматоидном артрите (исследование BIORA). Научно - практическая ревматология. 2016;54(5):510-9. https://doi.org/10.14412/1995-4484-2016-510-519
- Bredemeier M, de Oliveira F.K, Rocha C.M. Low - versus High - dose rituximab for rheumatoid arthritis: a systemic review and metaanalysis. Arthritis Care Res. 2014;66:228-35. https://doi.org/10.1002/acr.22116
- Buch M.H, Smolen J.S, Betteridge N, et al. Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70:909-20. doi: 10.1136/ard.2010.144998
- Sacco J.J, Botten J, Macbeth F, Bagust A, Clark P. The Average Body Surface Area of Adult Cancer Patients in the UK: A Multicentre Retrospective Study. PLoS ONE. 2010;5(1):e8933. doi: 10.1371/journal.pone.0008933
- Насонов Е.Л., Мазуров В.И., Зонова Е.В., Князева Л.А., Марусенко И.М. и др. Эффективность и безопасность биоаналога ритуксимаба (Ацеллбия®) при ревматоидном артрите в качестве «первого» генно - инженерного биологического препарата: результаты клинического исследования III фазы (ALTERRA). Научно - практическая ревматология. 2017;55(4):351-9. https://doi.org/10.14412/1995-4484-2017-351-359
- Cornec D, Avouac J, Youinou P, Saraux A. Critical analysis of rituximab - induced serological changes in connective tissue diseases. Autoimmun Rev. 2009;8:515-19. doi: 10.1016/j.autrev.2009.01.007
- Grosjean C, de Chaisemartin L, Nicaise-Roland P, et al. Prospective cohort study of rituximab effects on rheumatoid factor, anti - cyclic citrullinated peptide antibodies and antinuclear antibodies in patients with long - standing rheumatoid arthritis. Ann Rheum Dis. 2008;67(Suppl II):196.
- Александрова Е.Н., Авдеева А.С., Лукина Г.В., Новиков А.А., Черкасова М.В., Попкова Т.В., Линева О.Г., Кузикянц К.Х., Насонов Е.Л. Клинико - иммунологические эффекты анти-В-клеточной терапии у больных ревматоидным артритом. Научно - практическая ревматология. 2012;50(1):14-21. https://doi.org/ 10.14412/1995-4484-2012-498
- Cambridge G, Stohl W, Leandro M.J, et al. Circulating levels of Blymphocyte stimulator in patients with rheumatoid arthritis following rituximab treatment: relationship with B cell depletion, circulating antibodies, and clinical relapse. Arthritis Rheum. 2006;54:723-32. doi: 10.1002/art.21650
- Cohen S, Emery P, Greenwald M, et al. Rituximab for rheumatoid arthritis refractory to anti - tumor necrosis factor therapy. Results of multicenter, randomized, double - blind, placebo - controlled, phase III trial evaluating primary efficacy and safety at twenty - four weeks. Arthritis Rheum. 2006;54:2793-806. https://doi.org/10.1002/art. 22025
- Higashida J, Wun T, Schmidt S. Safety and Efficacy of Rituximab in Patients with Rheumatoid Arthritis Refractory to Disease Modifying Antirheumatic Drugs and Anti-Tumor Necrosis Factor - a Treatment. Rheumatology. 2005;32:2109-15.
- Tsiakalos A, Avgoustidis N, Moutsopoulos H. Rituximab therapy in Greek patients with rheumatoid arthritis. Biologics: Targets & Therapy. 2008;2:911-6. https://doi. org/10.2147/BTT.S3939
- Bokarewa M, Lindholm C, Zendjanchi K, et al. Efficacy of Anti-CD20 treatment in patients with rheumatoid arthritis resistant to a combination of methotrexate/anti-TNF therapy. Scand J Immunol. 2007;66:467-83. https://doi.org/10.1111/j.1365-3083.2007.01995.x
- Toubi E, Kesser A, Slobodin G, et al. Macrophage function changes following rituximab treatment in patients with rheumatoid arthritis. Ann Rheum Dis. 2007;66: 818-20. https://doi.org/10.1136/ard.2006.062505
- Vizioli C, Viana V, Ribeiro A. Auto - antibody titers for monitoring rituximab therapy in rheumatoid arthritis. Ann Rheum Dis. 2012;71(Suppl 3):667.
- Khandpur R, Carmona-Rivera C, Vivekanandan-Giri A, et al. NETs are a source of citrullinated autoantigens and stimulate inflammatory responses in rheumatoid arthritis. Sci Transl Med. 2013;5:178ra 40. doi: 10.1126/scitranslmed.3005580
- Aletaha D, Blüml S. Therapeutic implications of autoantibodies in rheumatoid arthritis. RMD Open. 2016;(2):e000009. doi: 10.1136/rmdopen-2014-000009
- Harre U, Georgess D, Bang H, et al. Induction of osteoclastogenesis and bone loss by human autoantibodies against citrullinated vimentin. J Clin Invest. 2012;122:1791-802. doi: 10.1172/JCI60975
- Harre U, Lang S.C, Pfeifle R, et al. Glycosylation of immunoglobulin G determines osteoclast differentiation and bone lose. Nat Communocation. 2015. doi: 10.1038/ ncomms7651
- Насонов Е.Л. Проблемы иммунопатологии ревматоидного артрита: эволюция болезни. Научно - практическая ревматология. 2017;55(3):277-94
- Bugatt S, Bogliolo L,Vitolo B, et al. Anti - citrullinated protein antibodies and high levels of rheumatoid factor are associated with systemic bone loss in patients with early untreated rheumatoid arthritis. Arthritis Res Ther. 2016;18:226. doi: 10.1186/s 13075- 016-1116-9
- Wigerblad G, Bas D.B, Fernades-Cerqueira C, et al. Autoantibodies to citrullinated proteins induce joint pain independent of inflammation via a chemokine - dependent mechanism. Ann Rheum Dis. 2016;75:730-8. doi: 10.1136/annrheumdis2015-208 094
- Zhang Z.J, Cao D.L, Zhang X, et al. Chemokine contribution to neuropathic pain: respective induction of CXCL1 and CXCR2 in spinal cord astrocytes and neurons. Pain. 2013;154:2185-97. doi: 10.1016/j.pain.2013.07.002
- Titcombe P.J, Amara K, Barsness L.O, et al. Citrullinatedself antigen - specific blood B cells carry cross reactive immunoglobulins with effector potential. Ann Rheum Dis. 2016;75(Suppl 1):A28-A29. doi: 10.1136/annrheumdis-2016-209124.68
- Engel P, Gómez-Puerta J, Ramos-Casals M, et al. Therapeutic targeting of B cells for rheumatic autoimmune diseases. Pharmacol Rev. 2011;63:127-56. doi.org/10.1124/pr.109.002006
- Lund F. Cytokine - producing B lymphocytes - key regulators of immunity. Curr Opin Immunol. 2008;20:332-8. doi.org/10.1016/j.coi.2008.03.003
- Manjarrez-Orduño N, Quách T, Sanz I, et al. B cells and immunological tolerance. J Invest Dermatol. 2009;129:278-88.
- Blom M, Wenink M.H, Huijbens R.J.F, et al. Altered circulating cytokine pattern after administration of rituximab is correlated with response to therapy in rheumatoid arthritis. Arthritis Rheum. 2008;26(Suppl):764.
- Fabre S, Gvisset C, Tatem L, et al. Protein biochip array technology to monitor rituximab in rheumatoid arthritis. Clin Exp Immunol. 2008;155:395-402. doi.org/10.1111/j.1365-2249.2008.03804.x
- Szekanecz Z, Koch A. Successes and failures of chemokine - pathway targeting in rheumatoid arthritis. Nat Rev Rheumatol. 2016 Jan;12(1):5-13. doi: 10.1038/ nrrheum.2015.157. https://doi.org/10.1038/nrrheum.2015.157
- Elyaman W, et al. IL-9 induces differentiation of TH17 cells and enhances function of FoxP3+ natural regulatory T cells. Proc Natl Acad Sci. 2009;106:12885-90. doi.org/10.1073/pnas.0812530106
- Nowak E.C, et al. IL-9 as a mediator of Th17-driven inflammatory disease. J Exp Med. 2009;206:1653-60. doi.org/10.1084/jem.20090246
- Bober L.A, et al. Regulatory effects of interleukin-4 and interleukin-10 on human neutrophil function ex vivo and on neutrophil influx in a rat model of arthritis. Arthritis Rheum. 2000;43:2660-7. doi.org/10.1002/1529-0131(200012)43:12<26 60::aid-anr5>3.0.co;2-4
- Smallie T, et al. IL-10 inhibits transcription elongation of the human TNF gene in primary macrophages. J Exp Med. 2010;207:2081-8. doi.org/10.1084/jem.20100414
- Van Roon J, et al. Interleukin 10 treatment of patients with rheumatoid arthritis enhances Fc gamma receptor expression on monocytes and responsiveness to immune complex stimulation. J Rheumatol. 2003;30:648-51.
- Wong C.K, et al. Effects of inflammatory cytokine IL-27 on the activation of fibroblast - like synoviocytes in rheumatoid arthritis. Arthritis Res Ther. 2010;12:R129. doi.org/10.1186/ar3067
- Emery P, Fleishmann R, Filipowicz-Sosnowska A, et al. For the DANCER Study group. The Efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment. Results of a phase IIb randomized, double - blind, placebo - controlled dose - range trial. Arthritis Rheum. 2006;54:1390-400. doi.org/10.1002/art.21778
- Emery P, Deodhar A, Rigby W, et al. Efficacy and Safety of different doses and retreatment of Rituximab: a randomized, placebo - controlled trial in patients who are biologically naïve with active rheumatoid arthritis and anadequate response to methotrexate (Study Evaluating Rituximab`s Efficacy in MTX inadequate responders (SERENA). Ann Rheum Dis. 2010;69:1629-35. doi.org/10.1136/ard.20 09.119933
- Rubbert-Roth A, Tak P, Zebrini C, et al. Efficacy and safety of various repeat treatment dosing regimes in Rituximab in patients with active rheumatoid arthritis: results of a phase III randomized study (MIRROR) dosing regimens of rituximab in patients with active RA: results of a phase III randomized study (MIRROR). Rheumatology. 2010;49:1683-93. doi.org/10.1093/rheumatology/keq401
- Roll P, Dorner T, Tony H-P. Anti-CD20 therapy in patients with rheumatoid arthritis: predictors of response and B cell subset regeneration after repeated treatment. Arthritis Rheum. 2008;58:1566-75. doi.org/10.1002/art.23473
- Van Vollenhoven R.F, Emery P, Bingham C.O, et al. Longterm safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol. 2010;37:558-67. doi.org/10.3899/jrheum.090856
- Mariette X, Kivitz A, Isaacs J, et al. Effectiveness of Rituximab (RTX) + methotrexate (MTX) in patients (pts) with early active rheumatoid arthritis (RA) and disease charaxteristics associated with poor outcomes. Arthritis Rheum. 2009;60 (Suppl):631.
- Tak P, Cohen S, Emery P, et al. Baseline autoantibody status (RF, ant-CCP) and clinical response following the first treatment course with rituximab. Arthritis Rheum. 2006;54(Suppl 9):368.
- Tak P, Rigby W, Rubbert-Roth A. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial. Ann Rheum Dis. 2011;70:39-46. doi.org/10.1136/ard.2010.137703
- Khan A, Mahmud T, Hammond T, et al. Rituximab (RTX) is more effective in active sero - positive RA than sero - negative RA. Arthritis Rheum. 2010;62(Suppl 10):1830.
- Isaacs J.D, Olech E, Tak P.P, et al. Autoantibody - positive rheumatoid arthritis patients have enchanced clinical response when compared with seronegative patients. Ann Rheum Dis. 2009;68(Suppl 3):442.
- Silverman G, Schwartzman S, Townsend M, et al. Identification of biomarkers for enhanced benefit to Rituximab in rheumatoid arthritis: role for autoantibodies and inflammatory markers. Arthritis Rheum. 2009;60(Suppl.):628.
- Sellam J, Hendel-Chavez H, Rouanet S, et al. B cell activation biomarkers as predictive factors for the response to rituximab in rheumatoid arthritis: a six - month, national, multicenter, open - label study. Arthritis Rheum. 2011;63:933-8. doi.org/ 10.1002/art.30233
- Thurling R, Boumans M, Vos K, et al. Early changes in serum levels of cytokines and chemokines are predictive of the response to Rituximab treatment in rheumatoid arthritis. Arthritis Rheum. 2009;60(Suppl.):630.