EN PL
GUIDELINES
Tofacitinib in the treatment of patients with rheumatoid arthritis: position statement of experts of the Polish Society for Rheumatology
 
More details
Hide details
 
Submission date: 2018-08-24
 
 
Acceptance date: 2018-08-30
 
 
Online publication date: 2018-08-31
 
 
Publication date: 2018-08-31
 
 
Reumatologia 2018;56(4):203-211
 
KEYWORDS
TOPICS
ABSTRACT
Tofacitinib is a newly approved small-molecule targeted synthetic disease-modifying antirheumatic drug. The drug was designed as a selective and specific inhibitor of pro-inflammatory receptor signalling. Tofacitinib inhibits the process of intracellular signalling from the receptor to the cellular nucleus and inhibits the inflammation process via a new pathway (inhibition of the Janus kinases), which is unavailable to biological medicines.
Tofacitinib has been approved for use in the treatment of patients with moderate to severe active RA. The drug may be used in combination with methotrexate or another conventional synthetic disease-modifying antirheumatic drug or in monotherapy. The efficacy of tofacitinib has been confirmed in several clinical trials. The drug inhibits radiographic progression of the disease. The innovative mechanism of action of tofacitinib is a noteworthy feature because it offers hope of effective treatment for patients who fail to respond to other drugs. The presented article discusses the mechanism of action and the clinical application of tofacitinib. Tofacitinib represents a new group of disease-modifying antirheumatic drugs that can be placed on an equal footing with biological drugs already available.
 
REFERENCES (48)
1.
Kucharz EJ. Reumatoidalne zapalenie stawów. In: Puszczewicz MJ (ed.). Wielka Interna. Medical Tribune, Warszawa 2016: 79-95.
 
2.
Smolen JS, van der Heijde D, Machold KP, et al. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Ann Rheum Dis 2014; 73: 3-5.
 
3.
Kucharz EJ, Stajszczyk M, Batko B, et al. Biopodobne leki biologiczne w reumatologii. Forum Reumatol 2017; 4: 191-204.
 
4.
Smolen JS, Landewé 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.
 
5.
Taylor PC, Sullivan E, Wood R, et al. Factors influencing treatment adjustments in rheumatoid arthritis patients – biologic DMARD treatment start and options. Arthritis Rheumatol 2015; 67 (Suppl 1): abstract no 2640.
 
6.
Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review Arthritis Res Ther 2009; 11 (Suppl 1): S1.
 
7.
Garcęs S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis 2013; 72: 1947-1955.
 
8.
van Vollenhoven RF, Geborek P, Forslind K, et al. Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial. Lancet 2012; 379: 1712-1720.
 
9.
Nikiphorou E, Negoescu A, Fitzpatrick JD, et al. Indispensable or intolerable? Methotrexate in patients with rheumatoid and psoriatic arthritis: a retrospective review of discontinuation rates from a large UK cohort. Clin Rheumatol 2014; 33: 609-614.
 
10.
Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003; 48: 35-45.
 
11.
Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999; 340: 253-259.
 
12.
Lipsky PE, van der Heijde DM, St Clair EW, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 2000; 343: 1594-1602.
 
13.
St Clair EW, van der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial Arthritis Rheum 2004; 50: 3432-3443.
 
14.
Tian H, Cronstein BN. Understanding the mechanisms of action of methotrexate: implications for the treatment of rheumatoid arthritis. Bull NYU Hosp Jt Dis 2007; 65: 168-173.
 
15.
Kucharz EJ. Zastosowanie leflunomidu w leczeniu chorych na reumatoidalne zapalenie stawów. Pol Arch Med Wewn 2001; 105: 177-182.
 
16.
Fragoso YD, Brooks JB. Leflunomide and teriflunomide: altering the metabolism of pyrimidines for the treatment of autoimmune diseases. Expert Rev Clin Pharmacol 2015; 8: 315-320.
 
17.
Tofacitinib: Summary of Product Characteristics. http://www.ema.europa.eu/docs/....
 
18.
Jiang JK, Ghoreschi K, Deflorian F, et al. Examining the chirality, conformation and selective kinase inhibition of 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile (CP-690,550). J Med Chem 2008; 51: 8012-8018.
 
19.
Kucharz EJ. Medical eponyms of mythological origin. Acta Neophilologica 2017; 19: 20-42.
 
20.
Bartosińska J, Zakrzewska E, Król A, et al. Differential expression of programmed death 1 (PD-1) on CD4+ and CD8+ T cells in rheumatoid arthritis and psoriatic arthritis. Pol Arch Intern Med 2017; 127: 815-822.
 
21.
Marzioli V, Canavan M, Wade S, et al. Tofacitinib impairs monocyte-derived dendritic cell differentiation in rheumatoid arthritis and psoriatic arthritis. Annual Congress of the European League Against Rheumatism, Amsterdam 2018, Abstract AB0046. Ann Rheum Dis 2018; 77 (Suppl): A1223.
 
22.
Lee EB, Fleischmann R, Hall S, et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med 2014; 370: 2377-2386.
 
23.
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.
 
24.
Kremer J, Li ZG, 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.
 
25.
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. Arthritis Rheum 2013; 65: 559-570.
 
26.
van Vollenhoven R, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 2012; 367: 508-519.
 
27.
Burmester GR, Blanco R, Charles-Schoeman CH, 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 randomised phase 3 trial. Lancet 2013; 381: 451-460.
 
28.
Fleischmann R, Mysler E, Hall S, et al. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexatein patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomized controlled trial. Lancet 2017; 390: 457-468.
 
29.
Cohen SB, Tanaka Y, Mariette X, et al. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis 2017; 76: 1253-1262.
 
30.
Wollenhaupt J, Silverfield J, Lee EB, et al. Tofacitinib, an oral Janus kinase inhibitor, in the treatment of rheumatoid arthritis: safety and efficacy in open-label, long-term extension studies over 9 Years. Arthritis Rheumatol 2017; 69 (Suppl 10). http://acrabstracts.org/abstra....
 
31.
Cohen S, Curtis JR, DeMasi R, et al. Worldwide, 3-year, post-marketing surveillance experience with tofacitinib in rheumatoid arthritis. Rheumatol Ther (in print) 2018 Feb 22. doi: 10.1007/s40744-018-0097-3.
 
32.
Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res 2016; 68: 1-25.
 
33.
Harnett J, Gerber R, Gruben D, et al. Evaluation of Real-World Experience with Tofacitinib Compared with Adalimumab, Etanercept, and Abatacept in RA Patients with 1 Previous Biologic DMARD: Data from a U.S. Administrative Claims Database. J Manag Care Spec Pharm 2016; 22: 1457-1471.
 
34.
Iwamoto N, Tsuji S, Takatani A, et al. Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis. PLoS ONE 2017; 12: e0177057.
 
35.
Schneeberger EE, Salas A, Medina LF, et al. Real-world use of tofacitinib in rheumatoid arthritis: data from Latin America. Ann Rheum Dis 2017; 76 (Suppl 2): 1196. http://ard.bmj.com/content/ann....
 
36.
Mimori T, Harigai M, Atsumi T, et al. Post-marketing surveillance of tofacitinib in Japanese patients with rheumatoid arthritis: an interim report of safety data [abstract]. Arthritis Rheumatol 2017; 69 (Suppl 10). http://acrabstracts.org/abstra... (accessed: 21.12.2017).
 
37.
Tarp S, Furst DE, Boers M, et al. Risk of serious adverse effects of biological and targeted drugs in patients with rheumatoid arthritis: a systematic review meta-analysis. Rheumatology 2017; 56: 417-425.
 
38.
Strand V, Ahadieh S, French J, et al. Systematic review and meta-analysis of serious infections with tofacitinib and biologic disease-modifying antirheumatic drug treatment in rheumatoid arthritis clinical trials. Arthritis Res Ther 2015; 17: 362-367.
 
39.
Winthrop KL, Curtis JR, Lindsey S, et al. Herpes zoster and tofacitinib: Clinical outcomes and the risk of concomitant therapy. Arthritis Rheumatol 2017; 69: 1960-1968.
 
40.
Winthrop KL, Silverfield J, Racewicz A, et al. The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis. Ann Rheum Dis 2016; 75: 687-695.
 
41.
Fleischmann R. Tofacitinib in the treatment of active rheumatoid arthritis in adults. Immunotherapy 2018; 10: 39-56.
 
42.
Alten R, Krüger K, Rellecke J, et al. Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach. Patient Prefer Adherence 2016; 10: 2217-2228.
 
43.
Louder AM, Singh A, Saverno K, et al. Patient preferences regarding rheumatoid arthritis therapies: a conjoint analysis. Am Health Drug Benefits 2016; 9: 84-93.
 
44.
Goodman SM, Springer B, Guyatt G, et al. 2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty. Arthritis Rheumatol 2017; 69: 1538-1551.
 
45.
Ogdie A, de Vlam K, McInnes IB, et al. Effect of Tofacitinib on reducing pain in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis [abstract]. Arthritis Rheumatol 2017; 69 (Suppl 10).
 
46.
Bartelds GM, Krieckaert ChLM, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011; 305: 1460-1468.
 
47.
Dikranian A, Gonzalez-Gay MA, Wellborne F, et al. The efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline Body Mass Index. Arthritis Rheumatol 2017; 69 (Suppl 10). http://acrabstracts.org/abstra... (accessed: 20.12.2017).
 
48.
Mease PJ, Kremer J, Cohen S, et al. Incidence of thromboembolic events in the management with tofacitinib patients with rheumatoid arthritis, psoriasis, psoriatic arthritis and ulcerative colitis development programs. Arthritis Rheumatol 2017; 69 (Suppl 10). http://acrabstracts.org/abstra....
 
Copyright: © Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji w Warszawie. This is an Open Access journal, all articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License (https://creativecommons.org/licenses/by-nc-sa/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
eISSN:2084-9834
ISSN:0034-6233
Journals System - logo
Scroll to top