ABSTRACT

Objectives:

In this study, we aimed to determine the clinical, laboratory and demographic characteristics of patients with rheumatoid arthritis (RA) using tofacitinib, and the drug survival rates.

Materials and Methods:

A total of 78 RA patients who were prescribed tofacitinib between May 2016 and July 2019 were retrospectively evaluated and included in the study. The clinical, laboratory and demographic features of the patients were recorded. Drug survival rates were analyzed using Kaplan-Meier survival analysis. P<0.05 was considered statistically significant.

Results:

The mean age of all patients was 58.6±11.3 years and 62 (79.4%) were female. Thirty-six (46.1%) of the patients had used biological disease modifying drug (DMARD) prior to the use of tofacitinib. In 28 (35.9%) patients, tofacitinib treatment was discontinued. When the characteristics of the patients were compared according to the continuation of tofasitinib, the initial SDAI score was significantly higher in the group in which tofacitinib was discontinued (p=0.028). Other features were similar between the groups. Drug survival was significantly higher in patients who underwent tofacitinib monotherapy at follow-up (p=0.012).

Conclusion:

Tofacitinib may be considered as an effective treatment agent in patients who cannot undergo remission with conventional DMARDs in the treatment of RA.

Keywords: Rheumatoid Arthritis, Tofacitinib, Drug Survival

References

Strand V, Khanna D. The impact of rheumatoid arthritis and treatment on patients’ lives. Clin Exp Rheumatol. 2010;28(3 Suppl 59):S32-40.

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.

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. Lancet. 2017;390:457-468.

Van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. Rheumatology (Oxford). 2016;55:1031-1041.

Aletaha D, Neogi T, Silman AJ, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62:2569-2581.

van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998;41:1845-1850.

Smolen JS, Breedveld FC, Schiff MH, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology. 2003;42:244-257.

Nurmohamed MT, Dijkmans BA. Are biologics more effective than classical disease-modifying antirheumatic drugs? Arthritis Res Ther. 2008;10:118.

Burmester GR, 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. Lancet. 2013;381:451-460.

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.

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.

Wollenhaupt J, Silverfield J, Lee EB, et al. Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-label, longterm extension studies. J Rheumatol. 2014;41:837-852.

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.

European Medicines Agency. Xeljanz (tofacitinib): assessment report. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004214/WC500224913.pdf. Accessed 31 Oct 2017.

Pope JE, Keystone E, Jamal S, et al. Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years. ACR Open Rheumatol. 2019;1:73-82.

Smolen JS, Kay J, Doyle MK, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374:210-221.

Klareskog L, Gaubitz M, Rodriguez-Valverde V, et al ; Etanercept Study 301 Investigators. 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.

Weinblatt ME, Keystone E, Furst DE, et al. Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study. Ann Rheum Dis. 2006;65:753-759.

Westhovens R, Kremer JM, Emery P, et al. Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. Clin Exp Rheumatol. 2014;32:553-562.

Souto A, Maneiro JR, Gomez-Reino JJ. Rate of discontinuation and drug survival of biologic therapies in rheumatoid arthritis: a systematic review and meta-analysis of drug registries and health care databases. Rheumatology. 2015;55:523-534.

Tofacitinib in Patients with Rheumatoid Arthritis: Single-center Experience Rheumatoid Arthritis and Tofacitinib

ABSTRACT

References