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1Academic Journal
Συγγραφείς: V. I. Petrov, A. Y. Ryazanova, D. A. Nekrasov, V. I. Svinukhov, N. S. Privaltseva, В. И. Петров, А. Ю. Рязанова, Д. А. Некрасов, В. И. Свинухов, Н. С. Привальцева
Πηγή: Safety and Risk of Pharmacotherapy; Том 10, № 1 (2022); 34-47 ; Безопасность и риск фармакотерапии; Том 10, № 1 (2022); 34-47 ; 2619-1164 ; 2312-7821 ; 10.30895/2312-7821-2022-10-1
Θεματικοί όροι: межлекарственное взаимодействие, monoclonal antibodies, interleukins, interleukin receptors, tocilizumab, rheumatoid arthritis, COVID-19, adverse drug reactions, pharmacovigilance, hepatotoxity, drug-drug interactions, моноклональные антитела, интерлейкины, рецепторы интерлейкинов, тоцилизумаб, ревматоидный артрит, нежелательные реакции, фармаконадзор, гепатотоксичность
Περιγραφή αρχείου: application/pdf
Relation: https://www.risksafety.ru/jour/article/view/253/461; https://www.risksafety.ru/jour/article/downloadSuppFile/253/199; https://www.risksafety.ru/jour/article/downloadSuppFile/253/226; https://www.risksafety.ru/jour/article/downloadSuppFile/253/227; https://www.risksafety.ru/jour/article/downloadSuppFile/253/236; Smolen JS, Aletaha D. Forget personalised medicine and focus on abating disease activity. Ann Rheum Dis. 2013;72(1):3–6. https://doi.org/10.1136/annrheumdis-2012-202361; Saki A, Rajaei E, Rahim F. Safety and efficacy of tocilizumab for rheumatoid arthritis: a systematic review and meta-analysis of clinical trial studies. Reumatologia. 2021;59(3):169–79. https://doi.org/10.5114/reum.2021.107026; Schiff MH, Kremer JM, Jahreis A, Vernon E, Isaacs JD, van Vollenhoven RF. Integrated safety in tocilizumab clinical trials. Arthritis Res Ther. 2011;13(5):R141. https://doi.org/10.1186/ar3455; Campbell L, Chen C, Bhagat SS, Parker RA, Östör AJ. Risk of adverse events including serious infections in rheumatoid arthritis patients treated with tocilizumab: a systematic literature review and meta-analysis of randomized controlled trials. Rheumatology (Oxford). 2011;50(3):552–62. https://doi.org/10.1093/rheumatology/keq343; Rutherford AI, Subesinghe S, Hyrich KL, Galloway JB. Serious infection across biologic-treated patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Ann Rheum Dis. 2018;77(6):905–10. https://doi.org/10.1136/annrheumdis-2017-212825; Yun H, Xie F, Delzell E, Levitan EB, Chen L, Lewis JD, et al. Comparative risk of hospitalized infection associated with biologic agents in rheumatoid arthritis patients enrolled in medicare. Arthritis Rheumatol. 2016;68(1):56–66. https://doi.org/10.1002/art.39399; Morel J, Constantin A, Baron G, Dernis E, Flipo RM, Rist S, et al. Risk factors of serious infections in patients with rheumatoid arthritis treated with tocilizumab in the French Registry REGATE. Rheumatology (Oxford). 2017;56(10):1746–54. https://doi.org/10.1093/rheumatology/kex238; Moots RJ, Sebba A, Rigby W, Ostor A, Porter-Brown B, Donaldson F, et al. Effect of tocilizumab on neutrophils in adult patients with rheumatoid arthritis: pooled analysis of data from phase 3 and 4 clinical trials. Rheumatology (Oxford). 2017;56(4):541–9. https://doi.org/10.1093/rheumatology/kew370; Choy E, Freemantle N, Proudfoot C, Chen C, Pollissard L, Kuznik A, et al. Evaluation of the efficacy and safety of sarilumab combination therapy in patients with rheumatoid arthritis with inadequate response to conventional disease-modifying antirheumatic drugs or tumour necrosis factor α inhibitors: systematic literature review and network meta-analyses. RMD Open. 2019;5(1):e000798. https://doi.org/10.1136/rmdopen-2018-000798; Puxeddu I, Caltran E, Rocchi V, Del Corso I, Tavoni A, Migliorini P. Hypersensitivity reactions during treatment with biological agents. Clin Exp Rheumatol. 2016;34(1):129–32. PMID: 26751942; Pichler WJ. Adverse side effects to biological agents. Allergy. 2006;61(8):912–20. https://doi.org/10.1111/j.1398-9995.2006.01058.x; Yun H, Xie F, Beyl RN, Chen L, Lewis JD, Saag KG, Curtis JR. Risk of hypersensitivity to biologic agents among medicare patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2017;69(10):1526–34. https://doi.org/10.1002/acr.23141; Salmon JH, Perotin JM, Morel J, Dramé M, Cantagrel A, Ziegler LE, et al. Serious infusion-related reaction after rituximab, abatacept and tocilizumab in rheumatoid arthritis: prospective registry data. Rheumatology (Oxford). 2018;57(1):134–9. https://doi.org/10.1093/rheumatology/kex403; Fleischmann RM, Tesser J, Schiff MH, Schechtman J, Burmester GR, Bennett R, et al. Safety of extended treatment with anakinra in patients with rheumatoid arthritis. Ann Rheum Dis. 2006;65(8):1006–12. https://doi.org/10.1136/ard.2005.048371; Mahamid M, Mader R, Safadi R. Hepatotoxicity of tocilizumab and anakinra in rheumatoid arthritis: management decisions. Clin Pharmacol. 2011;(3):39–43. https://doi.org/10.2147/cpaa.s24004; Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J. Long-term safety and efficacy of tocilizumab, an anti-interleukin-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis. 2009;68(10):1580–4. https://doi.org/10.1136/ard.2008.092866; Ogata A, Amano K, Dobashi H, Inoo M, Ishii T, Kasama T, et al. Longterm safety and efficacy of subcutaneous tocilizumab monotherapy: results from the 2-year open-label extension of the MUSASHI study. J Rheumatol. 2015;42(5):799–809. https://doi.org/10.3899/jrheum.140665; Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino J, Sebba A. Five-year efficacy and safety of tocilizumab monotherapy in patients with rheumatoid arthritis who were methotrexate- and biologic-naive or free of methotrexate for 6 months: the AMBITION study. J Rheumatol. 2017;44(2):142–7. https://doi.org/10.3899/jrheum.160287; Kim SC, Solomon DH, Rogers JR, Gale S, Klearman M, Sarsour K, et al. Cardiovascular safety of tocilizumab versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis: a multi-database cohort study. Arthritis Rheumatol. 2017;69(6):1154–64. https://doi.org/10.1002/art.40084; Kleveland O, Kunszt G, Bratlie M, Ueland T, Broch K, Holte E, et al. Effect of a single dose of the interleukin-6 receptor antagonist tocilizumab on inflammation and troponin T release in patients with non-ST-elevation myocardial infarction: a double-blind, randomized, placebo-controlled phase 2 trial. Eur Heart J. 2016;37(30):2406–13. https://doi.org/10.1093/eurheartj/ehw171; Yamamoto K, Goto H, Hirao K, Nakajima A, Origasa H, Tanaka K, Tomobe M, Totsuka K. Longterm Safety of Tocilizumab: Results from 3 Years of Followup Postmarketing Surveillance of 5573 Patients with Rheumatoid Arthritis in Japan. J Rheumatol. 2015 Aug;42(8):1368-75. doi:10.3899/jrheum.141210. Epub 2015 Jun 1. PMID: 26034149.; Harigai M, Nanki T, Koike R, Tanaka M, Watanabe-Imai K, Komano Y, Sakai R, Yamazaki H, Koike T, Miyasaka N. Risk for malignancy in rheumatoid arthritis patients treated with biological disease-modifying antirheumatic drugs compared to the general population: A nationwide cohort study in Japan. Mod Rheumatol. 2016 Sep;26(5):642-50. doi:10.3109/14397595.2016.1141740. Epub 2016 Mar 11. PMID: 26873430.; Luo P, Liu Y, Qiu L, Liu X, Liu D, Li J. Tocilizumab treatment in COVID-19: a single center experience. J Med Virol. 2020;92(7):814–8. https://doi.org/10.1002/jmv.25801; Xu X, Han M, Li T, Sun W, Wang D, Fu B, et al. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci USA. 2020;117(20):10970–5. https://doi.org/10.1073/pnas.2005615117; Fomina DS, Lysenko MA, Beloglazova IP, Mutovana ZYu, Poteshkina NG, Samsonova IV, et al. Temporal clinical and laboratory response to interleukin-6 receptor blockade with tocilizumab in 89 hospitalized patients with COVID-19 pneumonia. Pathog Immun. 2020;5(1):327–41. https://doi.org/10.20411/pai.v5i1.392; RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021;397(10285):1637–45. https://doi.org/10.1016/s0140-6736(21)00676-0; Gundling S, Popa A, Tumbush C, Hejal RB, Giddings OK, Teba C, John AR. Safety of tocilizumab in patients with Covid-19. Am J Respir Crit Care Med. 2021;203:A3805. https://doi.org/10.1164/ajrccm-conference.2021.203.1_MeetingAbstracts.A3805; Morena V, Milazzo L, Oreni L, Bestetti G, Fossali T, Bassoli C, et al. Off-label use of tocilizumab for the treatment of SARS-CoV-2 pneumonia in Milan, Italy. Eur J Intern Med. 2020;76:36–42. https://doi.org/10.1016/j.ejim.2020.05.011; Jiménez-Lozano I, Caro-Teller JM, Fernández-Hidalgo N, Miarons M, Frick MA, Batllori Badia E, et al. Safety of tocilizumab in COVID-19 pregnant women and their newborn: a retrospective study. J Clin Pharm Ther. 2021;46(4):1062–70. https://doi.org/10.1111/jcpt.13394; Campochiaro C, Della-Torre E, Cavalli G, De Luca G, Ripa M, Boffini N, et al. Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study. Eur J Intern Med. 2020;76:43–9. https://doi.org/10.1016/j.ejim.2020.05.021; Rezaei S, Fatemi B, Karimi Majd Z, Minaei H, Peikanpour M, Anjidani N, et al. Efficacy and safety of tocilizumab in severe and critical COVID-19: a systematic review and meta-analysis. Expert Rev Clin Immunol. 2021;17(5):499–511. https://doi.org/10.1080/1744666x.2021.1908128; https://www.risksafety.ru/jour/article/view/253