BIOLOGICAL AGENTS IN MEDICAL THERAPY
Keywords:
clinical pharmacology, biological agents
Abstract
Presented clinical pharmacology of biological products under the ATC classification system. The classification, characteristics of pharmacodynamics of drugs. An algorithm for the use of biological agents in therapeutic practice: rheumatology, gastroenterology, neurology. Examined in detail the absolute and relative contraindications and side effects of biological agents, as well as control measures in their long-term use.Downloads
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References
1. Каратеев Д. Е. Вопросы безопасности терапии ингибиторами ФНО / Д. Е. Каратеев // Соврем. ревматол. — 2009. — № 3. — С. 33—38.
2. Каратеев Д. Е. Современный взгляд на проблему быстропрогрессирующего ревматоидного артрита / Д. Е. Каратеев // Соврем. ревматол. — 2010. — № 2. — С. 37—42.
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4. Застосування антагоністів фактора некрозу пухлин в лікуванні хворих на ревматичні захворювання суглобів (ревматоїдний артрит, анкілозивний спондилоартрит, псоріатична артропатія): Метод. рекомендації / [Коваленко В. М., Шуба Н. М., Борткевич О. П. та ін.]. — Київ, 2008. — 40 с.
5. Коваленко В. М. Сучасні аспекти діагностики ревматоїдного артриту / В. М. Коваленко, О. П. Борткевич, Ю. В. Білявська // Здоров’я України. — 2010. — № 1 (березень). — С. 74—77.
6. Bergman M., Furfaro N. Individualizing therapy for rheumatoid arthritis: New strategies for maximizing treatment outcomes / M. Bergman, N. Furfaro // 2010 PCE Updates in Rheumatology. — 2010. — № 3 (2). — Р. 1—12.
7. Лучихина Е. Л. Ритуксимаб в современной терапии ревматоидного артрита / Е. Л. Лучихина // Соврем. ревматол. — 2008. — № 2. — С. 74—79.
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9. Emery P. 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-Ranging Trial / P. Emery, R. Fleischmann, A. Fillipowicz-Sosnowska [et al.] // Arthritis Rheum. — 2006. — № 54 (5). — Р. 1390—1400.
10. Насонов Е. Л. Фармакотерапия ревматоидного артрита в эру генно-инженерных биологических препаратов / Е. Л. Насонов // Терапевт. арх. — 2007. — № 5. — С. 5—8.
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17. Genovese M. C. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy / M. C. Genovese, M. Schiff, M. Luggen [et al.] // Ann. Rheum. Dis. — 2008. — № 67. — Р. 547—554.
18. Westhovens R. Disease remission is achieved within two years in over half of methotrexate naіve patients with early erosive rheumatoid arthritis (RA) treated with abatacept plus MTX: results from the AGREE Trial [abstract] / R. Westhovens, M. Robles, S. Nayiager [et al.] // Arthritis Rheum. — 2009. — № 60 (Suppl. 10). — Р. 638.
19. Westhovens R. Clinical efficacy and safety of abatacept in methotrexate-naпve patients with early rheumatoid arthritis and poor prognostic factors / R. Westhovens, M. Robles, A. C. Ximenes [et al.] // Ann Rheum Dis. — 2009. — № 68. — Р. 1870—1877.
20. Deighton C. Management of rheumatoid arthritis: summary of NICE guidance / C. Deighton, R. O’Mahony, J. Tosh [et al.] // BMJ. — 2009. — № 338. — b702.
21. Blom M., Kievit W., Fransen J. The reason for discontinuation of the first tumor necrosis factor (TNF) blocking agent does not influence the effect of a second TNF blocking agent in patients with rheumatoid arthritis / М. Blom, W. Kievit, J. Fransen [et al.] // J. Rheumatol. — 2009. — № 36. — Р. 2171—2177.
22. Emery P. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial / P. Emery, F. C. Breedveld, S. Hall [et al.] // Lancet. — 2008. — № 372. — Р. 375—382.
23. Hetland M. L. All Departments of Rheumatology in Denmark. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry / M. L. Hetland, I. J. Christensen, U. Tarp [et al.] // Arthritis Rheum. — 2010. — № 62. — Р. 22—32.
24. Hyrich K. L. British Society for Rheumatology Biologics Register. Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study / K. L. Hyrich, M. Lunt, K. D. Watson [et al.] // Arthritis Rheum. — 2007. — № 56. — Р. 13—20.
25. Karlsson J. A. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register / J. A. Karlsson, L. E. Kristensen, M. C. Kapetanovic [et al.] // Rheumatology (Oxford). — 2008. — № 47. — Р. 507—513.
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27. Pincus T. Why are only 50 % of courses of anti-tumor necrosis factor agents continued for only 2 years in some setting? Need for longterm observations in standart care to complement clinical trials / T. Pincus, Y. Yazici, R. van Vollenhoven // J. Rheumatol. — 2006. — № 33. — Р. 2372—2375.
28. Rubbert-Roth A., Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review / A. Rubbert-Roth, A. Finckh // Arthritis Res. Ther. — 2009. — № 11 (Suppl. 1). — S1.
29. Saag K. G. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis / K. G. Saag, G. G. Teng, N. M. Patkar [et al.] // Arthritis Rheum. — 2008. — № 59. — Р. 762—784.
30. Scrivo R. Switching between TNFalpha antagonists in rheumatoid arthritis: personal experience and review of the literature / R. Scrivo, F. Conti, F. R. Spinelli [et al.] // Reumatismo. — 2009. — № 61. — Р. 107—117.
31. Smolen J. S. GO-AFTER study investigators Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosisin patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial / J. S. Smolen, J. Kay, M. K. Doyle [et al.] // Lancet. — 2009. — № 374. — Р. 210—221.
32. Soubrier M. Evaluation of two strategies (initial methotrexate monotherapy vs its combination with adalimumab) in management of early active rheumatoid arthritis: data from the GUEPARD trial / M. Soubrier, X. Puechal, J. Sibilia [et al.] // Rheumatology (Oxford). — 2009. — № 48. — Р. 1429—1434.
33. Насонов Е. Л. Новые возможности фармакотерапии ревматических болезней — ингибирование интерлейкина-6 / Е. Л. Насонов // Клин. фармакол. тер. — 2008. — № 1. — С. 60—67.
34. Emery P. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial / P. Emery, E. Keystone, H. P. Tony [et al.] // Ann. Rheum. Dis. — 2008. — № 67. — Р. 1516—1523.
35. Nishimoto N., Kishimoto T. Interleukin 6, from bench to bedside / N. Nishimoto, T. Kishimoto // Nat. Clin. Praс. Rheumatol. — 2006. — № 11. — Р. 619—626.
36. Bone H. G. Effects of Denosumab on bone mineral density and bone turnover in postmenopausal women / H. G. Bone, M. A. Bolognese, C. K. Yuen // J. Clin. Endocrinol. Metab. — 2008. — № 93 (6). — Р. 2149—2157.
37. Brown J. P. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomised, blinded, Phase 3 trial / J. P. Brown, R. L. Prince, Deal Chad [et al.] // J. Bone Mineral Res. —2009. — № 24. — Р. 153—161.
38. Cummings S. R. Denosumab for prevention of fractures in postmenopausal women with osteoporosis / S. R. Cummings, J. San Martin, M. R. McClung [et al.] // N Engl J Med. — 2009. — № 361. — Р. 756—765.
39. Delmas P. Clinical potential of RANKL inhibition for the management of postmenopausal osteoporosis and other metabolic bone diseases / P. Delmas // J. Clin Densitometry: assessment of skeletal health. —2008. — Vol. 11 (2). — P. 325—338.
40. Geusens P. Emerging treatments for postmenopausal osteoporosis — focus on denosumab / P. Geusens // Clenical Interventions in ageing. — 2009. — № 4. — Р. 241—250.
41. Lewiecki E. M. Denosumab for the treatment of postmenopausal osteoporosis / E. M. Lewiecki // Women’s Health. — 2009. — № 5 (1). — Р. 15—22.
42. Lewecki E. M. Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD / E. M. Lewecki, P. D. Miller, M. R. McClung [еt al.] // J. Bone Miner Res. — 2007. — № 22. — Р. 1832—1841.
43. Miller P. D. Effect of Denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy; a randomized blinded phase 2 clinical trial / P. D. Miller, M. A. Bolognese, E M. Lewiecki [et al.] // Bone. — 2008. — № 3. — Р. 222—229.
44. Miller P. D. Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD / P. D. Miller, M. R. McClung [еt al.] // J. Bone Miner Res. —2007. — № 2. — Р. 1832—1841.
45. McClung M. R. Denosumab in Postmenopausal women with low bone mineral density / M. R. McClung, E. M. Lewiecki, B. C. Staneley // N Engl J Med. — 2006. — № 354. — Р. 821—831.
46. Van Vollenhoven R. F. Treatment of rheumatoid arthritis: state of the art 2009 / R. F. van Vollenhoven // Nat. Rev. Rheumatol. — 2009. — № 5. — Р. 531—541.
47. Furst D. E. Building towards a consensus for the use of tumour necrosis factor blocking agents / D. E. Furst, F. C. Breedveld, J. R. Kalden [et al.] // Ann Rheum Dis Dec. — 1999. — № 58. —
Р. 725—726.
2. Каратеев Д. Е. Современный взгляд на проблему быстропрогрессирующего ревматоидного артрита / Д. Е. Каратеев // Соврем. ревматол. — 2010. — № 2. — С. 37—42.
3. Сигидин Я. А., Лукина Г. В. Биологическая терапия в ревматологии / Я. А. Сигидин, Г. В. Лукина. — [2-е изд., доп.]. — М. : Практическая медицина, 2009. — 245 с.
4. Застосування антагоністів фактора некрозу пухлин в лікуванні хворих на ревматичні захворювання суглобів (ревматоїдний артрит, анкілозивний спондилоартрит, псоріатична артропатія): Метод. рекомендації / [Коваленко В. М., Шуба Н. М., Борткевич О. П. та ін.]. — Київ, 2008. — 40 с.
5. Коваленко В. М. Сучасні аспекти діагностики ревматоїдного артриту / В. М. Коваленко, О. П. Борткевич, Ю. В. Білявська // Здоров’я України. — 2010. — № 1 (березень). — С. 74—77.
6. Bergman M., Furfaro N. Individualizing therapy for rheumatoid arthritis: New strategies for maximizing treatment outcomes / M. Bergman, N. Furfaro // 2010 PCE Updates in Rheumatology. — 2010. — № 3 (2). — Р. 1—12.
7. Лучихина Е. Л. Ритуксимаб в современной терапии ревматоидного артрита / Е. Л. Лучихина // Соврем. ревматол. — 2008. — № 2. — С. 74—79.
8. Cohen S. B. REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to antitumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks / S. B. Cohen, P. Emery, M. W. Greenwald [et al.] // Arthritis Rheum. — 2006. — № 54. — Р. 2793—2806.
9. Emery P. 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-Ranging Trial / P. Emery, R. Fleischmann, A. Fillipowicz-Sosnowska [et al.] // Arthritis Rheum. — 2006. — № 54 (5). — Р. 1390—1400.
10. Насонов Е. Л. Фармакотерапия ревматоидного артрита в эру генно-инженерных биологических препаратов / Е. Л. Насонов // Терапевт. арх. — 2007. — № 5. — С. 5—8.
11. Насонов Е. Л. Ритуксимаб в лечении ревматических болезней / Е. Л. Насонов // Науч.-практич. ревматол. — 2008. — № 2 (прил. 1). — С. 3–10.
12. Keystone E. Safety and Efficacy of Additional Courses of Rituximab in Patients With Active Rheumatoid Arthritis. An Open-Label Extension Analysis / E. Keystone, R. Fleischmann, P. Emery // Arthritis Rheum. — 2007. — № 56 (12). — Р. 3896—3908.
13. Kremer J. M. Repeat treatment with rituximab in active RA patients: long-term efficacy in patients with one versus two or more prior TNF inhibitors / J. M. Kremer, H. P. Tony, M. C. Genovese [et al.] // Ann. Rheum. Dis. — 2007. — № 66 (Suppl). — Р. 432.
14. Mease P. J. B Cell-Targeted Therapy in Autoimmune Disease: Rationale, Mechanisms, and Clinical Application / P. J. Mease // J. Rheumatol. — 2008. — № 35. — Р. 1245—1255.
15. Tak P. P. Inhibition of joint damage and improved clinical outcomes with a combination of rituximab (RTX) and methotrexate (MTX) in patients (pts) with early active rheumatoid arthritis (RA) who are naïve to MTX: a randomised active comparator placebo-controlled trial [abstract] / P. P. Tak, W. Rigby, A. Rubbert [et al.] // Ann. Rheum. Dis. — 2009. — № 68 (Suppl. 3). — Р. 75.
16. Genovese M. C. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition / M. C. Genovese, J. C. Becker, M. Schiff [et al.] // N. Engl. J. Med. — 2005. — № 353. — Р. 1114—1123.
17. Genovese M. C. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy / M. C. Genovese, M. Schiff, M. Luggen [et al.] // Ann. Rheum. Dis. — 2008. — № 67. — Р. 547—554.
18. Westhovens R. Disease remission is achieved within two years in over half of methotrexate naіve patients with early erosive rheumatoid arthritis (RA) treated with abatacept plus MTX: results from the AGREE Trial [abstract] / R. Westhovens, M. Robles, S. Nayiager [et al.] // Arthritis Rheum. — 2009. — № 60 (Suppl. 10). — Р. 638.
19. Westhovens R. Clinical efficacy and safety of abatacept in methotrexate-naпve patients with early rheumatoid arthritis and poor prognostic factors / R. Westhovens, M. Robles, A. C. Ximenes [et al.] // Ann Rheum Dis. — 2009. — № 68. — Р. 1870—1877.
20. Deighton C. Management of rheumatoid arthritis: summary of NICE guidance / C. Deighton, R. O’Mahony, J. Tosh [et al.] // BMJ. — 2009. — № 338. — b702.
21. Blom M., Kievit W., Fransen J. The reason for discontinuation of the first tumor necrosis factor (TNF) blocking agent does not influence the effect of a second TNF blocking agent in patients with rheumatoid arthritis / М. Blom, W. Kievit, J. Fransen [et al.] // J. Rheumatol. — 2009. — № 36. — Р. 2171—2177.
22. Emery P. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial / P. Emery, F. C. Breedveld, S. Hall [et al.] // Lancet. — 2008. — № 372. — Р. 375—382.
23. Hetland M. L. All Departments of Rheumatology in Denmark. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry / M. L. Hetland, I. J. Christensen, U. Tarp [et al.] // Arthritis Rheum. — 2010. — № 62. — Р. 22—32.
24. Hyrich K. L. British Society for Rheumatology Biologics Register. Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study / K. L. Hyrich, M. Lunt, K. D. Watson [et al.] // Arthritis Rheum. — 2007. — № 56. — Р. 13—20.
25. Karlsson J. A. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register / J. A. Karlsson, L. E. Kristensen, M. C. Kapetanovic [et al.] // Rheumatology (Oxford). — 2008. — № 47. — Р. 507—513.
26. Østergaard M. Low remission rates but long drug survival in rheumatoid arthritis patients treated with infliximab or etanercept: results from the nationwide Danish DANBIOdatabase / M. Østergaard, J. Unkerskov, L. Linde [et al.] // Scand J. Rheumatol. — 2007. — № 36. — Р. 151—154.
27. Pincus T. Why are only 50 % of courses of anti-tumor necrosis factor agents continued for only 2 years in some setting? Need for longterm observations in standart care to complement clinical trials / T. Pincus, Y. Yazici, R. van Vollenhoven // J. Rheumatol. — 2006. — № 33. — Р. 2372—2375.
28. Rubbert-Roth A., Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review / A. Rubbert-Roth, A. Finckh // Arthritis Res. Ther. — 2009. — № 11 (Suppl. 1). — S1.
29. Saag K. G. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis / K. G. Saag, G. G. Teng, N. M. Patkar [et al.] // Arthritis Rheum. — 2008. — № 59. — Р. 762—784.
30. Scrivo R. Switching between TNFalpha antagonists in rheumatoid arthritis: personal experience and review of the literature / R. Scrivo, F. Conti, F. R. Spinelli [et al.] // Reumatismo. — 2009. — № 61. — Р. 107—117.
31. Smolen J. S. GO-AFTER study investigators Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosisin patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial / J. S. Smolen, J. Kay, M. K. Doyle [et al.] // Lancet. — 2009. — № 374. — Р. 210—221.
32. Soubrier M. Evaluation of two strategies (initial methotrexate monotherapy vs its combination with adalimumab) in management of early active rheumatoid arthritis: data from the GUEPARD trial / M. Soubrier, X. Puechal, J. Sibilia [et al.] // Rheumatology (Oxford). — 2009. — № 48. — Р. 1429—1434.
33. Насонов Е. Л. Новые возможности фармакотерапии ревматических болезней — ингибирование интерлейкина-6 / Е. Л. Насонов // Клин. фармакол. тер. — 2008. — № 1. — С. 60—67.
34. Emery P. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial / P. Emery, E. Keystone, H. P. Tony [et al.] // Ann. Rheum. Dis. — 2008. — № 67. — Р. 1516—1523.
35. Nishimoto N., Kishimoto T. Interleukin 6, from bench to bedside / N. Nishimoto, T. Kishimoto // Nat. Clin. Praс. Rheumatol. — 2006. — № 11. — Р. 619—626.
36. Bone H. G. Effects of Denosumab on bone mineral density and bone turnover in postmenopausal women / H. G. Bone, M. A. Bolognese, C. K. Yuen // J. Clin. Endocrinol. Metab. — 2008. — № 93 (6). — Р. 2149—2157.
37. Brown J. P. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomised, blinded, Phase 3 trial / J. P. Brown, R. L. Prince, Deal Chad [et al.] // J. Bone Mineral Res. —2009. — № 24. — Р. 153—161.
38. Cummings S. R. Denosumab for prevention of fractures in postmenopausal women with osteoporosis / S. R. Cummings, J. San Martin, M. R. McClung [et al.] // N Engl J Med. — 2009. — № 361. — Р. 756—765.
39. Delmas P. Clinical potential of RANKL inhibition for the management of postmenopausal osteoporosis and other metabolic bone diseases / P. Delmas // J. Clin Densitometry: assessment of skeletal health. —2008. — Vol. 11 (2). — P. 325—338.
40. Geusens P. Emerging treatments for postmenopausal osteoporosis — focus on denosumab / P. Geusens // Clenical Interventions in ageing. — 2009. — № 4. — Р. 241—250.
41. Lewiecki E. M. Denosumab for the treatment of postmenopausal osteoporosis / E. M. Lewiecki // Women’s Health. — 2009. — № 5 (1). — Р. 15—22.
42. Lewecki E. M. Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD / E. M. Lewecki, P. D. Miller, M. R. McClung [еt al.] // J. Bone Miner Res. — 2007. — № 22. — Р. 1832—1841.
43. Miller P. D. Effect of Denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy; a randomized blinded phase 2 clinical trial / P. D. Miller, M. A. Bolognese, E M. Lewiecki [et al.] // Bone. — 2008. — № 3. — Р. 222—229.
44. Miller P. D. Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD / P. D. Miller, M. R. McClung [еt al.] // J. Bone Miner Res. —2007. — № 2. — Р. 1832—1841.
45. McClung M. R. Denosumab in Postmenopausal women with low bone mineral density / M. R. McClung, E. M. Lewiecki, B. C. Staneley // N Engl J Med. — 2006. — № 354. — Р. 821—831.
46. Van Vollenhoven R. F. Treatment of rheumatoid arthritis: state of the art 2009 / R. F. van Vollenhoven // Nat. Rev. Rheumatol. — 2009. — № 5. — Р. 531—541.
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How to Cite
Lysenko, N. V., & Kartvelishvili, A. Y. (1). BIOLOGICAL AGENTS IN MEDICAL THERAPY. The Journal of V. N. Karazin Kharkiv National University, Series "Medicine", (24), 81-90. Retrieved from https://periodicals.karazin.ua/medicine/article/view/6713
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