GOLIMUMAB — A NEW TNF α-BLOCKER. THE REVIEW OF THE EFFICACY AND SAFETY EVALUATION RESULTS
https://doi.org/10.15690/vsp.v11i4.354
Abstract
The article represents the results of efficacy and safety evaluation of the human monoclonal antibodies — golimumab, according to the data of international multicenter randomized double-blind placebo-controlled trials, including patients with active stage of rheumatoid arthritis. It was shown, that golimumab was reliably more effective than placebo both when administered hypodermic and intravenous. The safety profile of golimumab is comparable to that of the other tumor necrosis factor alpha blockers. The review also contains information on the 3d phase of golimumab efficacy and safety research in patients with juvenile idiopathic arthritis.
About the Authors
R. V. Denisova
Scientific Centre of Children Health, RAMS, Moscow
Russian Federation
Rina Denisova, Candidate of Medical Science, senior research associate of rheumatologic department
Russian Federation
Rina Denisova, Candidate of Medical Science, senior research associate of rheumatologic department
E. I. Alexeeva
Scientific Centre of Children Health, RAMS, Moscow
I.M. Setchenov First Moscow State Medical University
Russian Federation
Russian Federation
References
1. Cassidy J. T., Petty R. E. Juvenile idiopathic arthritis / In:Cassidy J. T., Petty R. E. (eds). Textbook of pediatric rheumatology, 6th edn. Philadelphia: WB Saunders. 2010.
2. Ravelli A., Martini A. Juvenile idiopathic arthritis. Lancet. 2007; 369: 767–778.
3. Аннотация к препарату адалимумаб. URL: http://www.rlsnet.ru/
4. Аннотация к препарату этанерцепт. URL: http://www.rlsnet.ru/
5. Ruperto N., Lovell D. J., Cuttica R. et al. A randomized, placebocontrolled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2007; 56 (9): 3096–3106.
6. URL: http://clinicaltrials.gov/ct2/show/NCT01230827
7. Emery P., Fleischmann R. M., Moreland L. W. et al. Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebocontrolled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009; 60: 2272–2283.
8. Emery P., Fleischmann R., van der Heijde D. et al. Golimumab and radiographic progression in rheumatoid arthritis: results of GO-BEFORE and GO-FORWARD Studies [abstract 640]. Arthitis Rheum. 2009; 60.
9. Keystone E. C., Genovese M. C., Klareskog L. et al. Golimumab, a human antibody to tumour necrosis factor alpha given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann. Rheum. Dis. 2009; 68: 789–796.
10. Smolen J. S., Kay J., Doyle M. K. et al. Golimumab in 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. Lancet. 2009; 374: 210–221.
11. Weinblatt M. E., Bingham C. O., Mendelsohn A. M. et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, doubleblind, placebo-controlled GO-FURTHER trial. Ann. Rheum. Dis. doi:10.1136/annrheumdis-2012–201411.
12. URL: http://healtheconomics.ru/index.php?option=com_content&view=article&id=12513: fda&catid=1: latest-news&Itemid=107
13. URL: http://www.ros-med.info/reestr-ls/info.php?id=25527&action=info#short_info
14. Tracey D., Klareskog L., Sasso E. et al. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol. Ther. 2008; 117 (2): 244–279.
15. Golimumab Product Information. Centocor, Marvelan PA. 2009.
16. Zhou H., Jang H., Fleischmann R. M. et al. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J. Clin. Pharmacol. 2007; 47: 383–396.
17. Adalimumab Product Information. Abbott, Abbott Park, IL. 2010.
18. Kremer J., Ritchlin C., Mendelsohn A. et al. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: Forty-eightweek efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010; 62 (4): 917–928.
Review
For citations:
Denisova R.V., Alexeeva E.I. GOLIMUMAB — A NEW TNF α-BLOCKER. THE REVIEW OF THE EFFICACY AND SAFETY EVALUATION RESULTS. Current Pediatrics. 2012;11(4):14-20. (In Russ.) https://doi.org/10.15690/vsp.v11i4.354
Views:
1182
Email this article 
