Vol 6, No 1 (2020)
Review paper
Published online: 2020-07-01

open access

Page views 883
Article views/downloads 215
Get Citation

Connect on Social Media

Connect on Social Media

Tofacitinib in the treatment of rheumatoid arthritis

Dorota Sikorska1, Włodzimierz Samborski1
Forum Reumatol 2020;6(1):1-5.


The dynamic development of modern therapies for rheumatoid arthritis (RA) has been observed in recent years. Most of the new drugs are monoclonal antibodies, which are usually directed against specific proinflammatory cytokines. Unfortunately, despite an undoubted progress in the field of biological treatment, it is estimated that about 20–30% of patients with RA do not receive an adequate response to the treatment used. That is why new solut ons are constantly being sought. Janus kinase inhibitors (JAK) are drugs with a different intracellular mechanism of action. These drugs, due to their innovative mechanism of action, give hope for effective treatment of patients who do not respond to therapy with currently available drugs. One of the representatives of JAK inhibitors is tofacitinib. In this manuscript, we provide information on tofacitinib in the context of RA treatment.

Article available in PDF format

View PDF Download PDF file


  1. Caporali R, Crepaldi G, Codullo V, et al. 20 years of experience with tumour necrosis factor inhibitors: what have we learned? Rheumatology (Oxford). 2018; 57(57 Suppl 7): vii5–viivii10.
  2. Burgers LE, Raza K, van der Helm-van Mil AH. Window of opportunity in rheumatoid arthritis - definitions and supporting evidence: from old to new perspectives. RMD Open. 2019; 5(1): e000870.
  3. Rubbert-Roth A, Atzeni F, Masala IF, et al. TNF inhibitors in rheumatoid arthritis and spondyloarthritis: Are they the same? Autoimmun Rev. 2018; 17(1): 24–28.
  4. Biggioggero M, Crotti C, Becciolini A, et al. Tocilizumab in the treatment of rheumatoid arthritis: an evidence-based review and patient selection. Drug Des Devel Ther. 2019; 13: 57–70.
  5. Rubbert-Roth A, Szabó MZ, Kedves M, et al. Failure of anti-TNF treatment in patients with rheumatoid arthritis: The pros and cons of the early use of alternative biological agents. Autoimmun Rev. 2019; 18(12): 102398.
  6. Murdaca G, Spanò F, Contatore M, et al. Infection risk associated with anti-TNF-α agents: a review. Expert Opin Drug Saf. 2015; 14(4): 571–582.
  7. Wendling D, Prati C. Paradoxical effects of anti-TNF-α agents in inflammatory diseases. Expert Rev Clin Immunol. 2014; 10(1): 159–169.
  8. Rivellese F, Lobasso A, Barbieri L, et al. Novel Therapeutic Approaches in Rheumatoid Arthritis: Role of Janus Kinases Inhibitors. Curr Med Chem. 2019; 26(16): 2823–2843.
  9. Barrat FJ, Crow MK, Ivashkiv LB. Interferon target-gene expression and epigenomic signatures in health and disease. Nat Immunol. 2019; 20(12): 1574–1583.
  10. Malemud CJ. The role of the JAK/STAT signal pathway in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2018; 10(5-6): 117–127.
  11. McInnes I, Schett G. Pathogenetic insights from the treatment of rheumatoid arthritis. The Lancet. 2017; 389(10086): 2328–2337.
  12. Schwartz DM, Kanno Y, Villarino A, et al. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Drug Discov. 2017; 16(12): 843–862.
  13. T Virtanen A, Haikarainen T, Raivola J, et al. Selective JAKinibs: Prospects in Inflammatory and Autoimmune Diseases. BioDrugs. 2019; 33(1): 15–32.
  14. Serra López-Matencio JM, Morell Baladrón A, Castañeda S. JAK-STAT inhibitors for the treatment of immunomediated diseases. Med Clin (Barc). 2019; 152(9): 353–360.
  15. Banerjee S, Biehl A, Gadina M, et al. JAK-STAT Signaling as a Target for Inflammatory and Autoimmune Diseases: Current and Future Prospects. Drugs. 2017; 77(5): 521–546.
  16. Charakterystyka Produktu Leczniczego. ec.europa.eu/health/documents/community-register/2017/20170322137186/anx_137186_pl.pdf..
  17. Strand V, Lee EB, Fleischmann R, et al. Tofacitinib versus methotrexate in rheumatoid arthritis: patient-reported outcomes from the randomised phase III ORAL Start trial. RMD Open. 2016; 2(2): e000308.
  18. 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(4): 253–261.
  19. van der Heijde D, Strand V, Tanaka Y, et al. ORAL Scan Investigators. Tofacitinib in Combination With Methotrexate in Patients With Rheumatoid Arthritis: Clinical Efficacy, Radiographic, and Safety Outcomes From a Twenty-Four-Month, Phase III Study. Arthritis Rheumatol. 2019; 71(6): 878–891.
  20. 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, double-blind, head-to-head, randomised controlled trial. The Lancet. 2017; 390(10093): 457–468.
  21. Burmester G, 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 randomised phase 3 trial. The Lancet. 2013; 381(9865): 451–460.
  22. Fleischmann R, Kremer J, Cush J, et al. ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012; 367(6): 495–507.
  23. 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(7): 1253–1262.
  24. 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(12): 1457–1471.
  25. Caporali R, Zavaglia D. Real-world experience with tofacitinib for the treatment of rheumatoid arthritis. Clinical and experimental rheumatology. 2019; 37(3): 485–495.
  26. Mueller RB, Hasler C, Popp F, et al. Effectiveness, Tolerability, and Safety of Tofacitinib in Rheumatoid Arthritis: A Retrospective Analysis of Real-World Data from the St. Gallen and Aarau Cohorts. J Clin Med. 2019; 8(10).
  27. Tarp S, Eric Furst D, 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 (Oxford). 2017; 56(3): 417–425.
  28. Winthrop KL, Curtis JR, Lindsey S, et al. Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy. Arthritis Rheumatol. 2017; 69(10): 1960–1968.
  29. Singh JA, Saag KG, Bridges SL, et al. American College of Rheumatology. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016; 68(1): 1–25.
  30. 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(6): 960–977.
  31. Kucharz EJ, Stajszczyk M, Kotulska-Kucharz A, et al. Tofacitinib in the treatment of patients with rheumatoid arthritis: position statement of experts of the Polish Society for Rheumatology. Reumatologia. 2018; 56(4): 203–211.
  32. Program lekowy B.33. Leczenie reumatoidalnego zapalenia stawów i młodzieńczego idiopatycznego zapalenia stawów o przebiegu agresywnym (ICD-10 M 05, M 06, M 08). https://www.gov.pl/web/zdrowie/choroby-nieonkologiczne.