АБАТАЦЕПТ В ЛЕЧЕНИИ ЮВЕНИЛЬНОГО ИДИОПАТИЧЕСКОГО АРТРИТА: ДАННЫЕ МЕЖДУНАРОДНЫХ ИССЛЕДОВАНИЙ И ОПЫТ ИСПОЛЬЗОВАНИЯ В РЕСПУБЛИКЕ МОРДОВИЯ
Аннотация
Предлагаем обзор современных представлений о месте абатацепта в лечении ювенильного идиопатического артрита с акцентом на высокий профиль его безопасности и возможность использования у пациентов, рефрактерных к стандартной базисной терапии и ингибиторам фактора некроза опухоли . Представлены результаты клинических исследований по оценке эффективности и безопасности абатацепта при различных вариантах ревматоидного артрита у взрослых и ювенильного идиопатического артрита у детей. Раскрыты преимущества и перспективы использования препарата в детской ревматологии: возможность назначения в монотерапии, в т. ч. у пациентов с непереносимостью или недостаточной эффективностью метотрексата/ингибиторов фактора некроза опухоли . Авторами также приведены собственные данные о применении абатацепта у 8 детей с ювенильным идиопатическим артритом, проживающих в Республике Мордовия, в т. ч. составляющих группу риска по активации туберкулезной инфекции. 50% улучшения по педиатрическим критериям Американской коллегии ревматологов через 1 год наблюдения достигли 75% детей, половина из которых были рефрактерны к генно-инженерным биологическим препаратам.
Об авторах
Л. А. Балыкова
Медицинский институт Мордовского государственного университета им. Н.П. Огарёва, Саранск
Россия
Россия
Н. В. Ивянская
Детская республиканская клиническая больница, Саранск
Россия
Россия
А. В. Краснопольская
Медицинский институт Мордовского государственного университета им. Н.П. Огарёва, Саранск
Россия
Россия
П. А. Трупанова
Медицинский институт Мордовского государственного университета им. Н.П. Огарёва, Саранск
Россия
Россия
Список литературы
1. Ravelli A., Martini A. Juvenile idiopathic arthritis. Lancet. 2007; 369: 767–778.
2. Kahn P. Juvenile idiopathic arthritis: an update for the clinician. Bull NYU Hosp Jt Dis. 2012; 70 (3): 152–166.
3. Hashkes P. J., Laxer R. M. Medical treatment of juvenile idiopathic arthritis. JAMA. 2005; 294 (13): 1671–1684.
4. Beukelman T., Patkar N. M., Saag K. G., Tolleson-Rinehart S., Cron R. Q., DeWitt E. M. et al. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res. (Hoboken). 2011; 63 (4): 465–482.
5. Yuvenil'nyy artrit: klinicheskiye rekomendatsii dlya pediatrov. V knige: Detskaya revmatologiya [Juvenile Arthritis: Clinical Recommendations For Pediatricians. In the Book: Child Rheumatology]. Ed. Baranov A. A., Alekseyeva Ye. I. М.: Pediatr. 2013. 120 p.
6. Giannini E. H., Brewer E. J., Kuzmina N., Shaikov A., Maximov A., Vorontsov I., Fink C. W., Newman A. J., Cassidy J. T., Zemel L. S. Methotrexate in resistant juvenile rheumatoid arthritis. Results of the USA–USSR double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children’s Study Group. N. Engl. J. Med. 1992; 326 (16): 1043–1049.
7. Ruperto N., Murray K. J., Gerloni V., Wulffraat N., De Oliveira S. K. F., Falcini F., Dolezalova P., Alessio M., Burgos-Vargas R., Corona F., Vesely R., Foster H., Davidson J., Zulian F., Asplin L., Baildam E., Consuegra J. G., Ozdogan H., Saurenmann R., Joos R., Pistorio A., Woo P., Martini A. A randomized trial of parenteral methotrexate comparing an intermediate dose with a higher dose in children with juvenile idiopathic arthritis who failed to respond to standard doses of methotrexate. Arthritis Rheum. 2004; 50 (7): 2191–2201.
8. Lovell D. J., Giannini E. H., Reiff A., Cawkwell G. D., Silverman E. D., Nocton J. J. et al. and the Pediatric Rheumatology Collaborative Study Group. Etanercept in children with polyarticular juvenile rheumatoid arthritis. N. Engl. J. Med. 2000; 342: 763–769.
9. Lovell D. J., Ruperto N., Goodman S., Reiff A., Jung L., Jarosova K. et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N. Engl. J. Med. 2008; 359: 810–820.
10. Ruperto N., Lovell D. J., Cuttica R., Wilkinson N., Woo P., Espada G. et al. for the Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular course juvenile rheumatoid arthritis. Arthritis Rheum. 2007; 56: 3096–3106.
11. Minden K., Kiessling U., Listing J., Neiwers M., Doring E., Meincke J., Schontube N., Zink A. Prognosis of patients with juvenile chronic arthritis and juvenile spondyloarthropathy. J. Rheumatol. 2000; 27: 2256–2263.
12. Lovell D. J., Reiff A., Ilowite N. T., Wallace C. A., Chon Y., Lin Sh.-L., Baumgartner S. W., Giannini E. H. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum. 2008; 58 (5): 1496–1504.
13. Hashkes P. J., Uziel Y., Laxer R. M. The safety profile of biologic therapies for JIA. Nat. Rev. Rheumatol. 2010; 6 (10): 561–571.
14. Kitas G. D., Gabriel Sh. E. Cardiovascular disease in rheumatoid arthritis state of the art and future perspectives. Ann. Rheum. Dis. 2011; 70: 8–14.
15. Gabriel Sh. E. Heart disease and rheumatoid arthritis: understanding risk. Ann. Reum. Dis. 2010; 69 (Suppl. 1): 61–64.
16. Gudkova Ye.Yu., Alekseyeva Ye. I. Voprosi sovremennoi pediatrii — Current Pediatrics. 2007; 6 (5):74–80.
17. Fried S. K., Bunkin D. A., Greenberg A. S. Omental and subcutaneous adipose tissues of obese subjects release interleukin-6: depot difference and regulation by glucocorticoid. J. Clin. Endocrinol. & Metabolism. 1998; 83 (3): 847–850.
18. Pietrewicz E., Urban M. Early atherosclerosis changes in children with juvenile idiopathic arthritis. Polski Merkuriusz Lekarski. 2007; 22 (129): 211–214.
19. Vlahos A. P., Theocharis P., Bechlioulis A., Naka K. K., Vakalis K., Papamichael N. D., Alfantaki S., Gartzonika K., Mavridis A., Micha lis L. K., Siamopoulou A. Changes in vascular function and structure in juvenile idiopathic arthritis. Arthritis Care & Res. 2011; 63 (12): 1736–1744.
20. Choy E. H., Panayi G. S. Cytokine pathways and joint inflammation in rheumatoid arthritis N. Engl. J. Med. 2001;344: 907–916.
21. Yamada A., Salama A. D., Sayegh M. H. The role of novel T cell costimulatory pathways in autoimmunity and transplantation. J. Am. Soc. Nephrol. 2002; 13: 559–575.
22. Goeb V., Buch M. H., Vital E. M., Emery P. Costimulation blockade in rheumatic diseases: Where we are? Curr. Opin. Rheumatol. 2009; 21 (3): 244–250.
23. Linsley P. S., Brady W., Urnes M., Grosmaire L. S., Damle N. K., Ledbetter J. A. CTLA-4 is a second receptor for the B cell activation antigen B7. J. Exp. Med. 1991; 174: 561–569.
24. Hervey P. S., Keam S. J. Abatacept. BioDrugs. 2006; 20 (1): 53–61.
25. Davies P., Zhou L., Abraham R. Abatacept binds to the Fc receptor CD64 but does not mediate complement-dependent cytotoxicity or antibody-dependent cellular cytotoxicity. J. Rheumatol. 2007; 34: 280–289.
26. Kremer J. M., Dougados M., Emery P., Durez P., Sibilia J., Shergy W., Steinfeld S., Tindall E., Becker J.-C., Li T., Nuamah I. F., Aranda R., Moreland L. W. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005; 52 (8): 2263–2271.
27. Schiff M. Abatacept treatment for rheumatoid arthritis. Rheumatology (Oxford). 2011; 50 (3): 437–449.
28. Guyot P., Taylor P., Christensen R., Pericleous L., Drost P., Eijgelshoven I., Bergman G., Lebmeier M. Abatacept with methotrexate versus other biologic agents in treatment of patients with active rheumatoid arthritis despite methotrexate: a network metaanalysis. Arthritis Res. Ther. 2011; 13: 204.
29. Nam J. L., Winthrop K. L., van Vollenhoven et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann. Rheum. Dis. 2010; 69: 976–986.
30. Devine E. B., Alfonso-Cristanchp R., Sullivan S. D. Effectiveness of biologic therapies for rheumatoid arthritis: an indirect comparison approach. Pharmacotherapy. 2011; 31: 39–51.
31. Salliot C., Finckh A., Katchamart W., Lu Y, Sun Y., Bombardier C., Keystone E. Indirect comparisons of the efficacy of biological antirheumatic agents in rheumatoid arthritis in patients with an inadequate response to conventional disease-modifying antirheumatic drugs or to an anti-tumor necrosis factor agents: a meta- analysis. Ann. Rheum. Dis. 2011; 70: 266–271.
32. Schoels M., Aletaha D., Smolen J. S., Wong J. B. Comparative effectiveness and safety of biological treatment options after tumor necrosis factor inhibitor failure in rheumatoid arthritis: systemic review and indirect pair wise meta-analysis. Ann. Rheum. Dis. 2012; 71 (8): 1303–1308.
33. Ruderman E. M. Overview of safety of non-biologic and biologic DMARDs. Rheumatology. 2012; 51: 37–43.
34. Singh J. A., Wells G. A., Christensen R., Ghogomu E. T., Maxwell L., MacDonald J. K., Filippini G., Skoetz N., Francis D. K., Lopes L. C., Guyatt G. H., Schmitt J., La Mantia L., Weberschock T., Roos J. F., Siebert H., Hershan S., Cameron C., Lunn M. P. T., Tugwell P., Buchbinder R. Adverse effects of biologics: a network meta analysis and Cochrane overview (Review). Cochr. Database Syst. Rev. 2011; 16 (2): CD008794.
35. Singh J. A., Wells G. A., Christensen R., Ghogomu E. T., Maxwell L., MacDonald J. K., Filippini G., Skoetz N., Francis D. K., Lopes L. C., Guyatt G. H., Schmitt J., La Mantia L., Weberschock T., Roos J. F., Siebert H., Hershan S., Cameron C., Lunn M. P. T., Tugwell P., Buchbinder R. Adverse effects of biologics: a network metaanalysis and Cochrane overview (Review). Cochr. Database Syst. Rev. 2012; 16 (3): CD008795.
36. Salliot C., Dougados M., Gossec L. Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomized placebo-controlled trials. Ann. Rheum. Dis. 2009; 68: 25–32.
37. Weinblatt M., Combe B., Covucci A., Aranda R., Becker J. C., Keystone E. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and non biologic disease-modifying antirheumatic drugs: a one year randomized, placebo controlled study. Arthritis Rheum. 2006; 54: 2807–2816.
38. van den Oever I. A.M., van Sijl A. M., Nurmohamed M. T. Management of cardiovascular risk in patients with rheumatoid arthritis: evidence and expert opinion. Ther. Adv. Musculoskelet. Dis. 2013; 5 (4): 166–181.
39. Mikuls T. R., Fay B. T., Michaud K., Sayles H., Thiele G. M., Caplan L., Johnson D., Richards J. S., Kerr G. S., Cannon G. W., Reimold A. Associations of disease activity and treatments with mortality in men with rheumatoid arthritis: results from the VARA registry. Rheumatology. 2011; 50: 101–109.
40. Dixon W. G., Watson K. D., Lunt M., Hyrich K. L., Silman A. J., Symmons D. P. Reduction in the incidence of myocardial infarction in patients with rheumatoid arthritis who respond to anti-tumor necrosis factor alpha therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum. 2007; 56: 2905–2912.
41. Barnabe C., Martin B., Ghali W. Systematic review and metaanalysis: anti-tumor necrosis factor alpha therapy and cardiovascular events in rheumatoid arthritis. Arthritis Care Res. (Hoboken). 2011; 63: 522–529.
42. Ruperto N., Lovell D. J., Quartier P., Paz E., Rubio-Perez N., Silva C. A. et al. Abatacept in children with juvenile idiopathic arthritis: a randomised, doubleblind, placebo-controlled withdrawal trial. Lancet. 2008; 372 (9636): 383–391.
43. Ruperto N., Lovell D. J., Quartier P., Paz E., Rubio-Perez N., Silva C. A., Abud-Mendoza C., Burgos-Vargas R., Gerloni V., MeloGomes J. A., Saad-Magalhaes C., Chavez-Corrales J., Huemer C., Kivitz A., Blanco F. J., Foeldvari I., Hofer M., Horneff G., Huppertz H.-I., Job-Deslandre C., Loy A., Minden K., Punaro M., Nunez A. F., Sigal L. H., Block A. J., Nys M., Martini A., Giannini E. H. Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis Rheum. 2010; 62 (6): 1792–1802.
44. Ruperto N., Lovell D. J., LI T., Sztajnbok F., GoldensteinSchainberg C., Scheinberg M., for the paediatric rheumatology international trials organization (PRINTO) and the pediatric rheumatology collaborative study group (PRCSG). Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. Arthritis Care & Res. 2010; 62 (11): 1542–1551.
45. Durmoqicz E. L. Pediatric focused safety review. FDA [online]. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ ucm193143.pdf. Accessed 2010 Dec 21.
46. Ungar W. J., Costa V., Hancock-Howard R., Feldman B. M., Laxer R. M. Cost-effectiveness of biologics in polyarticular-course JIA patients unresponsive to disease modifying anti-rheumatic drugs. Arthritis Care Res. (Hoboken). 2011; 63 (1): 111–119.
47. Keystone E. C., Kremer J. M., Russell A. S. Switching patients with rheumatoid arthritis (RA) from intravenous (IV) to subcutaneous (SC) abatacept is well tolerated and sustains previously established efficacy [Abstract]. Arthritis Rheum. 2010; 62 (Suppl. 10): 176.
48. Khraishi M., Russell A., Olszynski W. P. Safety profile of abatacept in rheumatoid arthritis: A review. Clin. Ther. 2010; 32: 1855–1870.
49. Weinblatt M. E., Moreland L. W., Westhovens R., Cohen R. B., Kelly S. M., Khan N., Pappu R., Delaet I., Luo A., Gujrathi S., Hochberg M. C. Safety of abatacept administered intravenously in treatment of rheumatoid arthritis: Integrated analyses of up to 8 years of treatment from the abatacept clinical trial program. J. Rheumatol. 2013; 40: 787–797.
50. Tran T. N., Caspard H., Magrini F. Incidence density of serious infection, opportunistic infection, and tuberculosis associated with biologic treatment in patients with rheumatoid arthritis — a systematic evaluation of the literature. Open Access Rheumatology: Research and Reviews. 2013; 5: 21–32.
51. Flynn J. L., Goldstein M. M., Chan J. Triebold K.J., Pfeffer K., Lowenstein C.J., Schreiber R., Mak T.W., Bloom B. R. Tumor necrosis factor-alpha is required in the protective immune response against Mycobacterium tuberculosis in mice. Immunity. 1995; 2: 561–572.
52. Dixon W. G., Hyrich K. L., Watson K. D., Lunt M., Galloway J., Ustianowski A. et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: Results from the British Society for Rheumatology Biologics Register (BSRBR). Ann. Rheum. Dis. 2010; 69: 522–528.
53. Bigbee C. L., Gonchoroff D. G., Vratsanos G., Nadler S.G., Haggerty H.G., Flynn J.L. Abatacept treatment does not exacerbate chronic Mycobacterium tuberculosis infection in mice. Arthritis Rheum. 2007; 56: 2557–2565.
54. Abrams J. R., Kelley S. L., Hayes E., Kikuchi T., Brown M. J., Kang S. et al. Blockade of T lymphocyte costimulation with cytotoxic T lymphocyte-associated antigen 4-immunoglobulin (CTLA4Ig) reverses the cellular pathology of psoriatic plaques, including the activation of keratinocytes, dendritic cells, and endothelial cells. J. Exp. Med. 2000; 192: 681–694.
55. Simon T. A., Smitten A. L., Franklin J., Askling J., Lacaille D., Wolfe F., Hochberg M. C., Qi K., Suissa S. Malignancies in rheumatoid arthritis abatacept clinical development programme: an epidemiological assessment. Ann. Rheum. Dis. 2009; 68: 1819–1826.
56. Smitten A. L., Qi K., Simon T. A., Becker J. C. Autoimmune adverse events in the abatacept RA clinical development program: a safety analysis with >10,000 person-years of exposure. In: ACR Annual Scientific Meeting. San Francisco, CA. 2008. Poster 1673.
57. Lopez-Olivo M. A., Tayar J. H., Martinez-Lopez J. A., Pollono E. N., Cueto J. P., Gonzales-Crespo M. R., Fulton S., Suarez-Almazor M. E. Malignancies in patients with rheumatoid arthritis treated with biologic therapy. A Meta-analysis. JAMA. 2012; 308 (9): 898–908.
58. Takahashi N., Kojima T., Terabe K., Kaneko A., Kida D., Hirano Y., Fujibayashi T., Yabe Y., Takagi H., Oguchi T., Miyake H., Kato T., Fukaya N., Ishikawa H., Hayashi M., Tsuboi S., Kato D., Funahashi K., Matsubara H., Hattori Y., Hanabayashi M., Hirabara S., Yoshioka Y., Ishiguro N. Clinical efficacy of abatacept in Japanese rheumatoid arthritis patients. Mod. Rheumatol. 2013 Sept 23 (5): 904–912.
59. Germanidis G., Hytiroglou P., Zakalka M., Settas L. Reactivation of occult hepatitis B virus infection, following treatment of refractory rheumatoid arthritis with abatacept. J. Hepatol. 2012; 56 (6): 1420–1421.
60. Bauer H., Sibilia J., Moreau P., Messer L. Acute hepatitis E during biotherapy. J. Bone Spine. 2013; 80 (1): 91–92.
61. Atzeni F., Sarzi-Puttini P., Mutti A., Bugatti S., Cavagna L., Caporali R. Long-term safety of abatacept in patients with rheumatoid arthritis. Autoimmun. Rev. 2013; 12: 1115–1117. 62. Howite N. T. Update on biologics in juvenile rheumatoid arthritis. Curr. Opin. Rheumatol. 2008; 20: 613–618.
62. Goldzweig O., Hashkes Ph. J. Abatacept in the treatment of polyarticular JIA: development, clinical utility, and place in therapy. Drug Design, Development & Ther. 2011; 5: 61–70.
63. Kuemmerle-Deschner J. B., Benseler S. M. Abatacept in difficultto-treat juvenile idiopathic arthritis. Biologics: Targets & Ther. 2008; 2 (4): 865–874.
64. Maneiro R. J., Salgado E., Carmona L., Gomez-Reino J. J. Rheuma toid factor as predictor of response to abatacept, rituximab and tocilizumab in rheumatoid arthritis: Systematic review and meta-analysis. Semin Arthritis Rheum. 2013; 43 (1): 9–17.
65. Alekseyeva Ye. I., Valiyeva S. I., Bzarova T. M., Denisova R. V., Isayeva K. B., Sleptsova T. V., Mitenko Ye. V., Taybulatov N. I. Voprosi sovremennoi pediatrii — Current Pediatrics. 2013; 12 (4): 62–72.
66. Bzarova T. M., Alekseyeva Ye. I., Valiyeva S. I., Chomakhidze A. M., Isayeva K. B., Lisitsin A. O., Denisova R. V. Voprosi sovremennoi pediatrii — Current Pediatrics. 2010; 9 (4): 147–154.
67. Alekseyeva Ye. I., Valiyeva S. I., Sleptsova T. V. Voprosi sovremen noi pediatrii — Current Pediatrics. 2011; 10 (1): 2–7.
68. Kel'tsev V. A., Grebenkina L. I., Pryanichnikova N. S., Goryunov S. A., Lagoda N. V. Voprosi sovremennoi pediatrii — Current Pediatrics. 2012; 11 (6): 103–109.
69. Nikishina I. P. Nauchno-prakticheskaja revmatologija — SciencePractical Rheumatology. 2010; 4 (Appendix 2): 42–45.
Рецензия
Для цитирования:
Балыкова Л.А., Ивянская Н.В., Краснопольская А.В., Трупанова П.А. АБАТАЦЕПТ В ЛЕЧЕНИИ ЮВЕНИЛЬНОГО ИДИОПАТИЧЕСКОГО АРТРИТА: ДАННЫЕ МЕЖДУНАРОДНЫХ ИССЛЕДОВАНИЙ И ОПЫТ ИСПОЛЬЗОВАНИЯ В РЕСПУБЛИКЕ МОРДОВИЯ. Вопросы современной педиатрии. 2014;13(2):28-35. https://doi.org/10.15690/vsp.v13i2.970
For citation:
Balykova L.A., Ivyanskaya N.V., Krasnopol’skaya A.V., Trupanova P.A. ABATACEPT IN TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS: INTERNATIONAL DATA AND EXPERIENCE OF USAGE IN THE REPUBLIC OF MORDOVIA. Current Pediatrics. 2014;13(2):28-35. (In Russ.) https://doi.org/10.15690/vsp.v13i2.970
Просмотров: 605
Послать статью по эл. почте 
