ФАРМАКОЭКОНОМИЧЕСКИЙ АНАЛИЗ ГЕННО-ИНЖЕНЕРНЫХ БИОЛОГИЧЕСКИХ ПРЕПАРАТОВ, ПРИМЕНЯЕМЫХ В ЛЕЧЕНИИ ПСОРИАТИЧЕСКОГО АРТРИТА И АНКИЛОЗИРУЮЩЕГО СПОНДИЛОАРТРИТА


Цитировать

Полный текст

Открытый доступ Открытый доступ
Доступ закрыт Доступ предоставлен
Доступ закрыт Доступ платный или только для подписчиков

Аннотация

В статье представлены результаты фармакоэкономического анализа применения генно-инженерных биологических препаратов (ГИБП), применяемых в лечении псориатического артрита (ПсА) и анкилозирующего спондилоартрита (АС). Проведенный анализ клинических исследований и рекомендаций по лечению ПсА и АС не выявил значимых различий в эффективности и безопасности применяемых ГИБП. Показано, что внедрение современных ГИБП в схемы лечения ПсА и АС позволяет существенно повысить эффективность проводимого лечения на тяжелых стадиях заболевания. Проведенный фармакоэкономический анализ «минимизации затрат» продемонстрировал, что использование ЛС этанерцепт позволяет решить задачи по оптимизации медицинской помощи больным данной нозологией, значительно сокращает издержки системы здравоохранения по сравнению с другими ГИБП без потери в эффективности и безопасности проводимого лечения.

Полный текст

Доступ закрыт

Об авторах

И. Ю Зинчук

РОО «Московское фармацевтическое общество», Москва

Email: Zinchuk.87@mail.ru
к.ф.н., эксперт

Список литературы

  1. Насонов Е.Л., Коротаева Т.В., Рекомендации по лечению псориатического артрита. По поручению группы экспертов АРР.
  2. Wong K., Gladman D.D., Husted J., et al. Mortality studies in psoriatic arhritis. Arthritis Rheum. 1997;40:1868-72.
  3. Gladman D.D., Chandran V. Psoriatic arthritis. Oxford University Press. 2009. 160 p.
  4. Бадокин В.В. Симптоматическая терапия анкилозирующего спондилита. Современная ревматология. 2012;1:69-74.
  5. Gran J.T., Husby G., Hordvik M. Prevalence of ankylosing spondylitis in males and females in a young middle-aged populapopulation of Tromso, northern Norway. Ann Rheum Dis. 1985;44:359-67.
  6. Kaipiainen-Seppanen O., Aho K., Heliovaara M. Incidence and prevalence of ankylosing spondylitis in Finland. J. Rheum. 1997;24:496-99.
  7. Van der Linden S.M., Valkenburg H.A., de Jongh B.M., et al. The risk of developing ankylosing spondylitis in HLA-B27 positive individuals. A comparison of relatives of spondylitis patients with the general population. Arthr Rheum. 1984;27:241-49.
  8. Trontzas P., Andrianakos A., Miyakis S., et al. Seronegative pondyloarthropathies in Greece: a population-based study of prevalence, clinical pattern, and management. The ESORDIG study. Clin. Rheum. 2005;24:583-89.
  9. Балабанова Р.М., Эрдес Ш.Ф. Динамика заболеваемости анкилозирующим спондилоартритом (АС) за 2006-2011 гг. среди взрослого населения РФ. Научно-практическая ревматология. 2013;51:17-18.
  10. Coates L.C., Fransen J., Helliwell P.S. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann. Rheum. Dis. 2010;69(1):48-53.
  11. Cantini F., Niccoli L., Nannini C., et al. Criteria, frequency, and duration of clinical remission in psoriatic arthritis patients with peripheral involvement requiring second-line drugs. J. Rheumatol. Suppl. 2009;83:78-80.
  12. Frequency and duration of clinical remission in patients with peripheral psoriatic arthritis requiring second-line drugs. Rheumatology (Oxford). 2008;47(6):872-76.
  13. Saad A., Symmons D., Noyce P., et al. Risk and benefits of tumor necrosis factor-α-inhibitors in the management of psoriatic arthritis: systematic review and metaanalysis of randomized controlled trials. J. Rheumatol. 2008;35:883-90.
  14. Migliore A., Bizzi E., Broccoli S., et al. Lagana Indirect comparison of etanercept, infliximab, and adalimumab for psoriatic arthritis: mixed treatment comparison using placebo as common comparator. Clin. Rheumatol. 2011.
  15. Zochling J., Van der Heijde D., Burgos-Vargas R., et al. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2006;65:442-52.
  16. Gomez-Reino J.J., Carmona L. Witching. TNF antagonists in patients with chronic arthritis: an observational study of 488 patients over a four-year period. Arthritis Res. Ther. 2006;8:29.
  17. McHuge N., Van der Bosch F., Roedevand E., et al. Effective treatment for joint and skin symptoms with Adalimumab in combination with various DMARDs in patients with psoriatic arthritis: results of the STEREO trial. 26th Annual General Meeting of the British Society for Rhe OP. 2009. 21 p.
  18. Van den Bosch F., Reece R., Manger B., et al. Adalimumab (Humira) is Effective and Safe in Treating Psoriatic Arthritis (PsA) in Real-Life Clinical Practice: Preliminary Results of the STEREO Trial. Oasis Online Abstract Submission, Poster Presentation. 2006.
  19. Yang H., Epstein D., Bojke L., et al. Golimumab for the treatment of psoriatic arthritis. Health TechnolAssess. 2011;15(Suppl 1):87-95.
  20. Kay J., Matteson E.L., Dasgupta B., et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebocontrolled, dose-ranging study. Arthritis Rheum. 2008;58:964-75.
  21. Sterry W., Ortonne J.-P., Kirkham B., et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTArandomised double blind multicentre trial. BMJ. 2010;340:147.
  22. Saad A.A., Ashcroft D.M., Watson K.D., et al. Persistence with anti-tumour necrosis factor therapies in patients with psoriatic arthritis: observational study from the British Society of Rheumatology Biologics Register. Arthritis Res. Ther. 2009;11:52.
  23. Насонов Е.Л., Коротаева Т.В. Рекомендации по лечению псориатического артрита.
  24. Saad A., Symmons D., Noyce P., et al. Risk and benefits of tumor necrosis factor-а inhibitors in the management of psoriatic arthritis: systematic review and metaanalysis of randomized controlled trials. J. Rheumatol. 2008;35:883-90.
  25. Yang H., Epstein D., Bojke L., et al. Golimumab for the treatment of psoriatic arthritis. Health TechnolAssess. 2011;15(Suppl 1):87-95.
  26. Kay J., Matteson E.L., Dasgupta B., et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebocontrolled, dose-ranging study. Arthritis Rheum. 2008;58:964-75.
  27. Эрдес Ш.Ф. Лечение анкилозирующего спондилита (АС).
  28. Braun J., van den Berg R., Baraliakos. Ревматология X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann. Rheum. Dis. 2011; 70:896-904.
  29. Ревматология: Клинические рекомендации / Под ред. акад. РАМН Е.Л. Насонова. 2-е изд., испр. и доп. М., 2010. 752с.
  30. Braun J., van der Horst-Bruinsma I.E., Huang F., et al. Clinical efficacy and safety of etanercept versus sulfasalazine in ankylosing spondylitis patients: a randomized, doubleblind study (ASCEND Trial). Arthritis Rheum. 2011;63(6):1543-51.
  31. van der Heijde D., Sieper J., Maksymowych W.P.,et al. (Second) Update of the ASAS recommendations on the use of TNF-blockers in ankylosing spondylitis. Arthr. Rheum. 2009;60(Suppl 10):1790.
  32. van der Heijde D., Dijkmans B., Geusens P., et al. Efficacy and safety of Infliximab in patients with ankylosing spondylitis. Arthr. Rheum. 2005;52:582-91.
  33. Zochling J., van der Heijde D., Dougados M., et al. Current evidence for the management of ankylosing spondylitis: a systematic literature review for the ASAS/EULAR management recommendations in ankylosing spondylitis. Ann. Rheum. Dis. 2006;65:423-32.
  34. van der Heijde D., Kivitz A., Schiff M.H., et al.; ATLAS Study Group. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthr. Rheum. 2006;54:2136-46.
  35. Braun J., McHugh N., Singh A., et al. Improvement in patient-reported outcomes for patients with ankylosing spondylitis treated with etanercept 50 mg once-weekly and 25 mg twice-weekly. Rheumatology (Oxford). 2007;46:999-1004.
  36. Haibel H., Rudwaleit M., Listing J., et al. Efficacy of adalimumab in the treatment of axial spondylarthritis without radiographically defi ned sacroiliitis: results of a twelve week randomized, double-blind, placebo-controlled trial followed by an open-label extension up to week fifty-two. Arthr. Rheum. 2008;58:1981-91.
  37. Barkham N., Keen H.I., Coates L.C., et al. Clinical and imaging effi cacy of infliximab in HLA-B27-Positive patients with magnetic resonance imaging-determined early sacroiliitis. Arthr. Rheum. 2009;60:946-54.
  38. Heiberg M.S., Koldingsnes W., Mikkelsen K., et al. The comparative one-year performance of anti-tumor necrosis factor alpha drugs in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: results from a longitudinal, observational, multicenter study. Arthr. Rheum. 2008;59:234-40.
  39. Baraliakos X., Listing J., Brandt J., et al. Radiographic Progression in Patients with Ankylosing Spondylitis After 4 yrs of Treatment With the Anti-TNF-alpha Antibody Infliximab. Rheumatology. 2007;46(9):1450-53.
  40. Baraliakos X., Haibel H., Listing J., et al. Radiographic progression in ankylosing spondylitis - results after up to 8 years of anti-TNF treatment. Ann. Rheum. Dis. 2011; 70(Suppl 3):344.
  41. van der Heijde D., Pangan A.L., Schiff M.H., et al.; ATLAS Study Group. Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis. Ann. Rheum. Dis. 2008;67: 1218-21.
  42. Braun J., Baraliakos X., Listing J., et al. Differences in the incidence of flares or new onset of inflammatory bowel diseases in patients with ankylosing spondylitis exposed to therapy with anti-TNF agents. Arthr. Rheum. 2007;57:639-47.
  43. Rudwaleit M., Van den Bosch F., Kron M., et al. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res. Ther. 2010;12:R117.
  44. Cantini F., Niccoli L., Benucci M., et al. Switching from infl iximab to once-weekly administration of 50 mg etanercept in resistant or intolerant patients with ankylosing spondylitis: results of a fi fty-four-week study. Arthr. Rheum. 2006;55:812-16.
  45. Coates L.C., Cawkwell L.S., Ng N.W., et al. Real life experience confi rms sustained response to long-term biologics and switching in ankylosing spondylitis. Rheumatology (Oxford). 2008;47:897-900.
  46. Song I.H., Heldmann F., Rudwaleit M., et al. Different response to rituximab in tumor necrosis factor blocker-naive patients with active ankylosing spondylitis and in patients in whom tumor necrosis factor blockers have failed: a twenty-four-week clinical trial. Arthritis Rheum. 2010;62:1290-97.
  47. Song I.H., Heldmann H., Rudwaleit M., et al. Treatment of active ankylosing spondylitis with abatacept - an open label 24-week study. Ann. Rheum. Dis. 2010;69(Suppl 3):60.
  48. De Vries M.K., van der Horst-Bruinsma I.E., Nurmohamed M.T., et al. Immunogenicity does not influence treatment with etanercept in patients with ankylosing spondylitis. Ann Rheum Dis. 2009;68:531-35.
  49. Arends S., Lebbink H.R., Spoorenberg A., et al. The formation of autoantibodies and antibodies to TNF-α blocking agents in relation to clinical response in patients with ankylosing spondylitis. Clin. Exp. Rheumatol. 2010;28:661-68.
  50. Kavanaugh A., McInnes I., Mease P., et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60(4):976-86.
  51. Plasencia C., Pascual-Salcedo D., Nuo L. Influence of immunogenicity on the efficacy of longterm treatment of spondyloarthritis with infliximab. Clinical and epidemiological research. Ann Rheum Dis. 2012;71:1955-60. doi: 10.1136/annrheumdis-2011-200828
  52. Results from ATLAS, a Long-Term, Open-Label Extension Study Presented at ACR, Highlight Impact of HUMIRA on Signs and Symptoms and Other Disease Measures in Patients with Active AS / Abbott Reports Five-Year Data for HUMIRA® (Adalimumab) in Ankylosing Spondylitis.

Дополнительные файлы

Доп. файлы
Действие
1. JATS XML
Скачать

© ООО «Бионика Медиа», 2014

Данный сайт использует cookie-файлы

Продолжая использовать наш сайт, вы даете согласие на обработку файлов cookie, которые обеспечивают правильную работу сайта.

О куки-файлах