Несвоевременные мысли о применении генно-инженерных биологических препаратов при ревматических болезнях
Аннотация
В течение последних двух десятилетий разработан целый ряд инновационных генно-инженерных биологических препаратов, внедрение которых в клиническую практику позволило существенно улучшить результаты лечения ревматических болезней. В то же время отмечается нарастание числа сообщений о связанных с их применением неблагоприятных реакциях, нередко парадоксальных (показанное при многих аутоиммунных процессах назначение этих препаратов может вызвать аналогичные аутоиммунные процессы ).
Об авторах
Ю. В. Муравьев
ФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой
Россия
115522 Москва, Каширское шоссе, 34А
Россия
115522 Москва, Каширское шоссе, 34А
Л. А. Муравьева
Центральное поликлиническое отделение МБУЗ «Химкинская центральная клиническая больница»
Россия
141400 Московская область, Химки, ул. Чкалова, 2/21
Конфликт интересов: 2/21, Chkalov St., Khimki, Moscow Region 141400
Россия
141400 Московская область, Химки, ул. Чкалова, 2/21
Конфликт интересов: 2/21, Chkalov St., Khimki, Moscow Region 141400
Список литературы
1. Haraoui B. Differentiating the efficacy of the tumor necrosis factor inhibitors. Semin Arthritis Rheum. 2005;34:7-11. doi: 10.1016/j.semarthrit.2005.01.003
2. Nurmohamed MT, Dijkmans BA. Efficacy, tolerability and cost effectiveness of disease-modifying antirheumatic drugs and biologic agents in rheumatoid arthritis. Drugs. 2005;65:661-94. doi: 10.2165/00003495-200565050-00006
3. Bongartz T, Sutton AJ, Sweeting MJ, et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;95:2275-85. doi: 10.1001/jama.295.19.2275
4. Genovese MC, Bathon JM, Fleischmann RM, et al. Long-term safety, efficacy and radiographic outcomes with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005;32:1232-42.
5. Lebwohl M, Gottlieb A, Wallis W, Zitnik R. Safety and efficacy of over 7 years of etanercept therapy ina global population of patients with rheumatoid arthritis. J Am Acad Dermatol. 2005;52:195. doi: 10.1016/j.jaad.2004.10.788
6. Haraoui B, Keystone E. Musculoskeletal manifestations and autoimmune diseases related to new biologic agents. Curr Opin Rheumatol. 2006;18:96-100. doi: 10.1097/01.bor.0000198007.73320.6e
7. Rubin RL. Drug-induced lupus. Toxicology. 2005;209:135-47. doi: 10.1016/j.tox.2004.12.025
8. Helmick CG, Felson DT, Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part 1. Arthritis Rheum. 2008;58:15-25. doi: 10.1002/art.23177
9. Lawrence RC, Felson DT, Helmick CG, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part 2. Arthritis Rheum. 2008;58:26-35. doi: 10.1002/art.23176
10. Ioannidis JP, Karassa FB, Druyts E, et al. Biologic agents in rheumatology: unmet issues after 200 trials and $200 billion sales. Nat Rev Rheumatol. 2013;11:665-73. doi: 10.1038/nrrheum.2013.134
11. Light DW. Pharmaceutical sales representatives and patient safety. J Gen Intern Med. 2013;28 (11):1394. doi: 10.1007/s11606-013-2559-1
12. Mintzes B, Lexchin J, Wilkes MS, et al. Pharmaceutical sales representatives and patient safety. J Gen Intern Med. 2013;28(11):1395. doi: 10.1007/s11606-013-2563-5
13. Mintzes B, Lexchin J, Sutherland J, et al. Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States. J Gen Intern Med. 2013;28(10):1368-75. doi: 10.1007/s11606-013-2411-7
14. Khan NA, Lombeida JI, Singh M, et al. Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis. Arthritis Rheum. 2012;64:2059-67. doi: 10.1002/art.34393
15. Schmucker C, Schell LK, Portalupi S, et al. Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries. PLoS One. 2014;9(12):e114023. doi: 10.1371/journal.pone.0114023
16. Gotzsche PC. Reference bias in reports of drug trials. Br Med J (Clin Res Ed). 1987;295(6599):654-6. doi: 10.1136/bmj.295.6599.654
17. Lopez-Olivo MA, Tayar JH, Martinez-Lopez JA, et al. Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis. JAMA. 2012;308:898-908. doi: 10.1001/2012.jama.10857
18. Yadav S, Singh S, Harmsen WS, et al. Effect of medications on risk of cancer in patients with inflammatory bowel diseases: A population-based cohort study from Olmsted County, Minnesota. Mayo Clin Proc. 2015 Jun;90(6):738-46. doi: 10.1016/j.mayocp.2015.03.024. Epub 2015 May 9.
19. Thompson AE, Rieder SW, Pope JE. Tumor necrosis factor therapy and the risk of serious infection and malignancy in patients with early rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum. 2011;63:1479-85. doi: 10.1002/art.30310
20. Singh JA, Wells GA, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011;(2):CD008794. doi: 10.1002/14651858.CD008794.pub2
21. Ramos-Casals M, Brito-Zeron P, Munoz S, et al. Autoimmune diseases induced by TNF-targeted therapies: analysis of 233 cases. Medicine (Baltimore). 2007;86(4):242-51. doi: 10.1097/MD.0b013e3181441a68
22. Ramos-Casals M, Brito-Zeron P, Soto MJ, et al. Autoimmune diseases induced by TNF-targeted therapies. Best Pract Res Clin Rheumatol. 2008;22(5):847-61. doi: 10.1016/j.berh.2008.09.008
23. Ramos-Casals M, Perez-Alvarez R, Diaz-Lagares C, et al. Autoimmune diseases induced by biological agents: a doubleedged sword? Autoimmun Rev. 2010;9:188-93. doi: 10.1016/j.autrev.2009.10.003
24. Ramos-Casals M, Brito-Zeron P, Munoz S, Soto MJ. A systematic review of the off-label use of biological therapies in systemic autoimmune diseases. Medicine (Baltimore). 2008;87:345-64. doi: 10.1097/MD.0b013e318190f170
25. Perez-Alvarez R, Perez-de-Lis M, Ramos-Casals M; BIOGEAS study group. Biologics-induced autoimmune diseases. Curr Opin Rheumatol. 2013;25(1):56-64. doi: 10.1097/BOR.0b013e32835b1366
26. Mendonc JA, Marques-Neto JF, Samara AM, Appenzeller S. Increased levels of rheumatoid factors after TNF inhibitor in rheumatoid arthritis. Rheumatol Int. 2012;32:815-8. doi: 10.1007/s00296-011-1812-3
27. Parekh K, Ching D, Rahman MU, Stamp LK. Onset of Wegener's granulomatosis during therapy with golimumab for rheumatoid arthritis: a rare adverse event? Rheumatology (Oxford). 2010;49:1785-7. doi: 10.1093/rheumatology/keq101
28. Fonollosa A, Artaraz J, Les I, et al. Sarcoid intermediate uveitis following etanercept treatment: a case report and review of the literature. Ocul Immunol Inflamm. 2012;20:44-8. doi: 10.3109/09273948.2011.623212
29. Bessissow T, Renard M, Hoffman I, et al. Review article: nonmalignant haematological complications of antitumour necrosis factor alpha therapy. Aliment Pharmacol Ther. 2012;36:312-23. doi: 10.1111/j.1365-2036.2012.05189.x
30. Illei GG, Shirota Y , Yarboro CH, et al. Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study. Arthritis Rheum. 2010;62:542-52. doi: 10.1002/art.27221
31. Муравьев ЮВ, Гридина ГИ, Каратеев ДЕ. Тромбоэмболия – неожиданная неблагоприятная реакция, возникшая в период применения ингибитора фактора некроза опухоли α адалимумаба. Научно-практическая ревматология. 2013;51(3):354-6 [Muravyev YV, Gridina GI, Karateev DE. Thromboembolism is an unexpected poor response resulting from the use of the tumor necrosis factor α inhibitor adalimumab. Nauchno-Prakticheskaya Revmatologiya = Rheumatology Science and Practice. 2013;51(3):354-6 (In Russ.)]. doi: 10.14412/1995-4484-2013-1514
32. Malisiewicz B, Murer C, Pachlopnik Schmid J, et al. Eosinophilia during psoriasis treatment with TNF antagonists. Dermatology. 2011;223:311-5. doi: 10.1159/000334805
33. Aouba A, de Bandt M, Aslangul E, et al. Haemophagocytic syndrome in a rheumatoid arthritis patient treated with infliximab. Rheumatology (Oxford). 2003;42:800-2. doi: 10.1093/rheumatology/keg187
34. Oda Y, Urushidani Y, Ooi S, et al. Hemophagocytic lymphohistiocytosis in a rheumatoid arthritis patient treated with infliximab. Intern Med. 2012;51:655-7. doi: 10.2169/internalmedicine.51.5687
35. Numakura T, Matsuura Y, Takiguchi H, et al. Tuberculosis associated with hemophagocytic syndrome complicated by treatment with infliximab. Nihon Kokyuki Gakkai Zasshi. 2010;48:449-53.
36. Araki D, Fujii H, Matsumura M, et al. Etanercept-induced lupus accompanied by hemophagocytic syndrome. Intern Med. 2011;50:1843-8. doi: 10.2169/internalmedicine.50.5430
37. Sandhu C, Chesney A, Piliotis E, et al. Macrophage activation syndrome after etanercept treatment. J Rheumatol. 2007;34:241-2.
38. Ramanan AV, Schneider R. Macrophage activation syndrome following initiation of etanercept in a child with systemic onset juvenile rheumatoid arthritis. J Rheumatol. 2003;30:401-3.
39. Mehta BM, Hashkes PJ, Avery R, Deal CL. A 21-year-old man with Still's disease with fever, rash, and pancytopenia. Arthritis Care Res (Hoboken). 2010;62:575-9. doi: 10.1002/acr.20001
40. Bosch X, Saiz A, Ramos-Casals M; BIOGEAS Study Group. Monoclonal antibody therapy-associated neurological disorders. Nat Rev Neurol. 2011;7:165-72. doi: 10.1038/nrneurol.2011.1
41. Nozaki K, Silver RM, Stickler DE, et al. Neurological deficits during treatment with tumor necrosis factor-alpha antagonists. Am J Med Sci. 2011;342:352-5. doi: 10.1097/MAJ.0b013e31822b7bb8
42. Brigo F, Bongiovanni LG, Cerini R, et al. Infliximab-related seizures: a first case study. Epileptic Disord. 2011;13:214-7.
43. Stubgen JP. Tumor necrosis factor-alpha antagonists and neuropathy. Muscle Nerve. 2008;37:281-92. doi: 10.1002/mus.20924
44. Ramos-Casals M, Perez-Alvarez R, Perez-de-Lis M, et al. Pulmonary disorders induced by monoclonal antibodies in patients with rheumatologic autoimmune diseases. Am J Med. 2011;124:386-94. doi: 10.1016/j.amjmed.2010.11.028
45. Perez-Alvarez R, Perez-de-Lis M, Diaz-Lagares C, et al. Interstitial lung disease induced or exacerbated by TNF-targeted therapies: analysis of 122 cases. Semin Arthritis Rheum. 2011;41:256-64. doi: 10.1016/j.semarthrit.2010.11.002
46. Hadjinicolaou AV, Nisar MK, Parfrey H, et al. Noninfectious pulmonary toxicity of rituximab: a systematic review. Rheumatology (Oxford). 2012;51:653-62. doi: 10.1093/rheumatology/ker290
47. Wendling D, Paccou J, Berthelot JM, et al. New onset of uveitis during antitumor necrosis factor treatment for rheumatic diseases. Semin Arthritis Rheum. 2011;41:503-10. doi: 10.1016/j.semarthrit.2011.05.005
48. Wendling D, Dernis E, Prati C, et al. Onset of inflammatory eye disease undertocilizumab treatment for rheumatologic conditions: a paradoxical effect? J Rheumatol. 2011;38:2284. doi: 10.3899/jrheum.110170
49. Van Dijken TD, Vastert SJ, Gerloni VM, et al. Development of inflammatory bowel disease in patients with juvenile idiopathic arthritis treated with etanercept. J Rheumatol. 2011;38:1441-6. doi: 10.3899/jrheum.100809
50. Toussirot E, Houvenagel E, Goö b V, et al. Development of inflammatory bowel disease during anti-TNF-a therapy for inflammatory rheumatic disease: a nationwide series. Joint Bone Spine. 2011 [Epub ahead of print].
51. Sekkach Y, Hammi S, Elqatni M, et al. Ulcerative colitis: exceptional consequence after rituximab therapy. Ann Pharm Fr. 2011;69:265-9. doi: 10.1016/j.pharma.2011.06.005
52. Bhalme M, Hayes S, Norton A, et al. Rituximab-associated colitis. Inflamm Bowel Dis. 2012 [Epub ahead of print].
53. ElFassi D, Nielsen CH, Junker P, et al. Systemic adverse events following rituximab therapy in patients with Graves' disease. J Endocrinol Invest. 2011;34:e163-7.
54. Goetz M, Atreya R, Ghalibafian M, et al. Exacerbation of ulcerative colitis after rituximab salvage therapy. Inflamm Bowel Dis. 2007;13:1365-8. doi: 10.1002/ibd.20215
55. Ardelean DS, Gonska T, Wires S, et al. Severe ulcerative colitis after rituximab therapy. Pediatrics. 2010;126:e243-6. doi: 10.1542/peds.2009-3395
56. Fiehn C, Vay S. Induction of inflammatory bowel disease flares by golimumab: report of three patients with enteropathic spondylarthritis or ankylosing spondylitis and comorbid colitis. Arthritis Rheum. 2011;63:3640-1. doi: 10.1002/art.30546
57. Collamer AN, Battafarano DF. Psoriatic skin lesions induced by tumor necrosis factor antagonist therapy: clinical features and possible immunopathogenesis. Semin Arthritis Rheum. 2010;40:233-40. doi: 10.1016/j.semarthrit.2010.04.003
58. Shmidt E, Wetter DA, Ferguson SB, Pittelkow MR. Psoriasis and palmoplantarpustulosis associated with tumor necrosis factor-a inhibitors: the Mayo Clinic experience, 1998 to 2010. J Am Acad Dermatol. 2011;67:e179-85. doi: 10.1016/j.jaad.2011.05.038
59. Harrison MJ, Dixon WG, Watson KD, et al. Rates of new-onset psoriasis in patients with rheumatoid arthritis receiving antitumour necrosis factor alpha therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis. 2009;68:209-15. doi: 10.1136/ard.2007.087288
60. Thomas L, Canoui-Poitrine F, Gottenberg JE, et al. Incidence of new-onset and flare of preexisting psoriasis during rituximab therapy for rheumatoid arthritis: data from the French AIR registry. J Rheumatol. 2012;39:893-8. doi: 10.3899/jrheum.111347
61. Kato K, Satoh T, Nishizawa A, Yokozeki H. Psoriasiform drug eruption due to abatacept. Acta Derm Venereol. 2011;91:362-3. doi: 10.2340/00015555-1042
62. Konsta M, Rallis E, Karameris A, et al. Psoriasiform lesions appearing in three patients with rheumatoid arthritis during therapeutic administration of abatacept, a selective inhibitor of T-cell costimulation. J Eur Acad Dermatol Venereol. 2012;26:257-8. doi: 10.1111/j.1468-3083.2011.04042.x
63. Brigant F, Clavel G, Chatelain D, et al. A case of generalized guttate psoriasis induced by etanercept with relapse after abatacept. Dermatol Online J. 2011;17:11.
64. Gonzalez-Lopez MA, Martinez-Taboada VM, Gonzalez-Vela MC, et al. Newonset psoriasis following treatment with the interleukin-1 receptor antagonist anakinra. Br J Dermatol. 2008;158:1146-8. doi: 10.1111/j.1365-2133.2008.08470.x
65. Hawryluk EB, Linskey KR, Duncan LM, Nazarian RM. Broad range of adverse cutaneous eruptions in patients on TNF-alpha antagonists. J Cutan Pathol. 2012;39:481-92. doi: 10.1111/j.1600-0560.2012.01894.x
66. Brunasso AM, Laimer M, Massone C. Paradoxical reactions to targeted biological treatments: a way to treat and trigger? Acta Derm Venereol. 2010;90:183-5. doi: 10.2340/00015555-0777
67. Piga M, Chessa E, Ibba V, et al. Biologics-induced autoimmune renal disorders in chronic inflammatory rheumatic diseases: systematic literature review and analysis of a monocentric cohort. Autoimmun Rev. 2014;13(8):873-9. doi: 10.1016/j.autrev.2014.05.005
Для цитирования:
Муравьев Ю.В., Муравьева Л.А. Несвоевременные мысли о применении генно-инженерных биологических препаратов при ревматических болезнях. Научно-практическая ревматология. 2016;54(3):361-366. https://doi.org/10.14412/1995-4484-2016-361-366
For citation:
Muravyev Yu.V., Muravyeva L.A. TARDY IDEAS ON THE USE OF BIOLOGICAL AGENTS IN RHEUMATIC DISEASES. Rheumatology Science and Practice. 2016;54(3):361-366. (In Russ.) https://doi.org/10.14412/1995-4484-2016-361-366
Просмотров: 349
Послать статью по эл. почте 
