Tofacitinib: efficiency and safety in long-term use
https://doi.org/10.21518/2079-701X-2019-1-64-71
Abstract
The article presents the data of international and domestic controlled studies, in which the effectiveness of topacitinib in the period of 6-24 months is evaluated in respect of clinical and laboratory manifestations of RA activity, progression of destructive arthritis and functional ability of rheumatoid arthritis patients. Also the data of efficiency and safety of tofacitinib in long terms - up to 96 months - are given. According to the results of short- and long-term studies, tofacitinib is a highly effective drug for the treatment of patients with active RA who have not responded to standard therapy with UCVD and GIBP. Tofacitinib is also highly effective in monotherapy. Tolerability of the drug is comparable with other variants of RA treatment.
About the Author
N. V. Chichasova
Federal State Autonomous Educational Institution of Higher Education «First Moscow State Medical University named after I.M. Sechenov»
of the Ministry of Health of the Russian Federation (Sechenov University);
Federal State Budgetary Scientific Institution «Research Institute of Rheumatology named after V.A. Nasonova»
Russian Federation
Dr. of Sci. (Med), Professor of the Department of Rheumatology at the Institute of Postgraduate Education of the Federal State Autonomous Educational Institution of Higher Education «I.M. Sechenov First Moscow State Medical University named after I.M. Sechenov» of the Ministry of Health of the Russian Federation (Sechenov University); Federal State Budgetary Scientific Institution «Research Institute of Rheumatology named after V.A. Nasonova»
Russian Federation
Dr. of Sci. (Med), Professor of the Department of Rheumatology at the Institute of Postgraduate Education of the Federal State Autonomous Educational Institution of Higher Education «I.M. Sechenov First Moscow State Medical University named after I.M. Sechenov» of the Ministry of Health of the Russian Federation (Sechenov University); Federal State Budgetary Scientific Institution «Research Institute of Rheumatology named after V.A. Nasonova»
References
1. Smolen J.S., Landewe R., Bijlsma J., et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017; 76: 960-977.
2. Smolen J.S., Aletaha D., Bijlsma J.W., et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010; 69: 631-637.
3. Winthrop K.L., Strand V., van der Heijde D.M., et al. The unmet need in rheumatology: reports from the Targeted Therapies meeting 2016. Clin Exp Rheumatol. 2016; 34(4 Suppl 98): 69-76.
4. Meyer D.M., Jesson M.I., Li X., et al. Antiinflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm. 2010; 7: 41.
5. Karaman M.W., Herrgard S., Treiber D.K., et al. A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol. 2008; 26: 127-132.
6. Hodle J.A., Kawabata T.T., Krishnaswami S., et al. The mechanism of action of tofacitinib – an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Clin Exp Rheumat. 2016; 34: 318-328.
7. Nasonov E.L. Pharmacotherapy of rheumatoid arthritis: new strategy, new targets. [Nauchno-prakticheskaya revmatologiya] Scientific and practical rheumatology. 2017; 55(4):409-19. (In Russ).
8. Maeshima K., Yamoaka K., Kubo S., et al. The JAK inhibitor tofacitinib regulates synovitis through inhibition of interferon-gamma and interleukin-17 production by human CD4+ N cells. Arthr Rheum. 2012; 64: 1790-1798.
9. Pfizer Ltd. Xeljanz (tofacitinib): summary of product characteristics. 2017. http://www.ema. europa.eu/does/en_GB/document_library/ EPAR_-_Product_Information/human/004214/ WC500224911.pdf. Accessed 31 Oct 2017.
10. Lee E.B., Fleischmann R., Hall S., et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014; 370: 2377-2386.
11. Fleischmann R., Kremer J., Cush J., et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012; 367: 495-507.
12. Fleischmann R., Mysler E., Hall S., et al. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, doubleblind, head-to-head, randomized controlled trial. Lancet. 2017; 390: 457-468.
13. Van der Heijde D., Tanaka Y., Fleischmann R., et al. Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study. Arthr Rheum. 2013; 65:559-570.
14. Van Vollenhoven R.F., Fleischmann R., Cohen S., et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012; 367: 508-519.
15. Kremer J., Li Z.G., Hall S., et al. Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2013; 159: 253-261.
16. Burmester G.R., Blanco R., Charles-Schoeman C., et al. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomized phase 3 trial. Lancet. 2013; 381: 451-460.
17. Fleischmann R., Mease P.J., Schwartzman S., et al. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group. Clin Rheum. 2017; 36: 15-24.
18. Strand V., van Vollenhoven R.F., Lee E.B., et al. Tofacitinib or adalimumab versus placebo: patient reported outcomes from a phase 3 study of active rheumatoid arthritis. Rheumatology (Oxford). 2016; 55: 1031-1041.
19. Landewe R.B., Connell C.A., Bradley J.D., et al. Is radiographic progression in modern rheumatoid arthritis trials still a robust outcome? Experience from tofacitinib clinical trials. Arthritis Res Ther. 2016; 18: 212.
20. Russian clinical recommendations. Rheumatology. Edited by Academician Nasonov E.L. M.: «GEOTAR-Media». 2017, 456 с. (In Russ).
21. Luchikhina E.L., Karateev D.E., Demidova N.V., et al. Efficacy and safety of tofacitinib therapy in patients with active rheumatoid arthritis with resistance to standard therapy: preliminary results of an open clinical study. [Sovr revmatologiya] Modern rheumatology. 2016; 10 (2): 17-23. (In Russ).
22. Fleischmann R., Wollenhaupt J., Takiya L., et al. Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies. RMD Open. 2017; 3:e000491. doi10.1136/rmdopen-2017-000491.
23. Fleischmann R., van Vollenhoven R.F., Vencovsky J., et al. Long-term maintenance of certolizumab pegol safety and efficacy, in combination with methotrexate and as monotherapy, in rheumatoid arthritis patients. Rheumatol Ther. 2017; 4: 57-69.
24. Klareskog L., Gaubitz M., Rodriguez-Valverde V., et al. Assessment of long-term safety and efficacy of etanercept in a 5-year extension study in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2011; 29: 238-247.
25. Furst D.E., Kavanaugh А., Florentius S., et al. Final 10-year effectiveness and safety results from study DEO20: adalimumab treatment in patients with rheumatoid arthritis and inadequate response to standard therapy. Rheumatology. 2015; 54: 2188-2197.
26. Curtis J.R., Schulze-Koops H., Takiya L., et al. Efficacy and safety of tofacitinib in older and younger patients with rheumatoid arthritis. Clin Exp Rheumatol. 2017; 35: 390-400.
27. Watanabe T., Hattori T., Ogawa S.Y., Jodo S. Successful treatment with tofacitinib for renal disorder due to amyloid A amyloidosis and immunoglobulin A nephropathy in patient with rheumatoid arthritis. Clin Exp Rheumatol. 2018; 36:683-684.
28. Hagihara R., Nishikawa T., Isobe T., et al. IL-6 plays a critical role in the synergistic induction of human serum amyloid A (SAA) gene when stimulated with proinflammatory cytokines as analyzed with SAA isoform real-time quantitative RT-PCR assay system. Biochem Biophis Res Commun. 2004; 314: 363-369.
29. Migita K., Koga T., Komori A., et al. Influence of Janus kinase inhibition on interleukin 6-mediated induction of acute-phase serum amyloid A in rheumatoid synovium. J Rheumatol. 2011; 38: 2309-2317.
30. Migita K., Izumi Y., Jiuchi Y., et al. Effects of Janus kinase inhibitor tofacitinib on circulating serum amyloid A and interleukin-6 during treatment for rheumatoid arthritis. Clin Exp Immunol. 2014; 175: 208-214.
31. Hodge J.A., Kawabata T.T., Krishnaswami S., et al. The mechanism of action of tofacitinib – an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2016; 34: 318-328.
32. Schwartz D.M., Kanno Y., Villarini A., et al. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Drug Discov. 2017; 16: 843-862.
33. Singh J.A., Hossain A., Tanjong Ghogomu E., et al. Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis (Review). Cochrane Database of Systematic Reviews. 2017, Issue 3. Art. No.: CD012591. doi: 10.1002/14651858.CD012591.
Review
For citations:
Chichasova NV. Tofacitinib: efficiency and safety in long-term use. Meditsinskiy sovet = Medical Council. 2019;(1):64-71. (In Russ.) https://doi.org/10.21518/2079-701X-2019-1-64-71
Views:
915
Email this article 