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Drug Safety Evaluation

The safety of baricitinib in patients with rheumatoid arthritis

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Pages 545-551 | Received 27 Jan 2020, Accepted 12 Mar 2020, Published online: 21 Mar 2020

References

  • Aletaha D, Smolen JS. Diagnosis and management of rheumatoid arthritis: a review. JAMA. 2018;320:1360–1372..
  • Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol. 2017;69:506–517.
  • Emery P, Bingham CO 3rd, Burmester GR, et al. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naive patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017;76:96–104.
  • Choquette D, Bessette L, Alemao E, et al. Persistence rates of abatacept and TNF inhibitors used as first or second biologic DMARDs in the treatment of rheumatoid arthritis: 9 years of experience from the Rhumadata(R) clinical database and registry. Arthritis Res Ther. 2019;21:138.
  • Schwartz DM, Kanno Y, Villarino A, et al. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Drug Discov. 2017;16:843–862.
  • Clark JD, Flanagan ME, Telliez JB. Discovery and development of Janus kinase (JAK) inhibitors for inflammatory diseases. J Med Chem. 2014;57:5023–5038.
  • Fridman JS, Scherle PA, Collins R, et al. Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of INCB028050. J Immunol. 2010;184:5298–5307.
  • Firestein GS, Budd R, Gabriel SE, et al. Kelley and Firestein’s textbook of rheumatology e-book elsevier health sciences; 2016:1048 [cited 2020 Mar 18]. Available from: https://www.elsevier.com/books/kelley-and-firesteins-textbook-of-rheumatology/9780323316965
  • Summary of product characteristics; 2017 [cited 2020 Mar 18]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004085/WC500223723.pdf
  • Posada MM, Cannady EA, Payne CD, et al. Prediction of transporter-mediated drug-drug interactions for baricitinib. Clin Transl Sci. 2017;10:509–519.
  • Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374:1243–1252.
  • Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017;76:88–95.
  • Li ZH, Bao J, Li C. X. SAT0218 Efficacy and safety of baricitinib in mtx-ir patients with rheumatoid arthritis: 52 week results from a phase 3 study (RA-BALANCE). Ann Rheum Dis. 2018;77(Suppl 2):969–70.
  • Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376:652–662.
  • Takeuchi T, Genovese MC, Haraoui B, et al. Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study. Ann Rheum Dis. 2019;78:171–178.
  • Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment. J Rheumatol. 2019;46:7–18.
  • Kay J, Harigai M, Rancourt J, et al. FRI0092 Effects of baricitinib on haemoglobin and related laboratory parameters in rheumatoid arthritis patients. Ann Rheum Dis. 2017;76(Suppl 2):513–4.
  • Kremer JH, Chen TWJ, Saifan L. C. FRI0090 Analysis of neutrophils, lymphocytes, and platelets in pooled phase 2 and phase 3 studies of baricitinib for rheumatoid arthritis. Ann Rheum Dis. 2017;76(Suppl 2):512.
  • Robertson J, Porter D, Sattar N, et al. Interleukin-6 blockade raises LDL via reduced catabolism rather than via increased synthesis: a cytokine-specific mechanism for cholesterol changes in rheumatoid arthritis. Ann Rheum Dis. 2017;76:1949–1952.
  • Kunwar S, Collins CE, Constantinescu F. Baricitinib, a Janus kinase inhibitor, in the treatment of rheumatoid arthritis: a systematic literature review and meta-analysis of randomized controlled trials. Clin Rheumatol. 2018;37:2611–2620.
  • Harigai M. Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019;58:i34–i42..
  • Smolen JS, et al. Profile of baricitinib in japanese patients with active rheumatoid arthritis with over 1.6 years median time in treatment: an integrated analysis of phases 2 and 3 trials. Mod Rheumatol. 2020;30:36–43.
  • Yi-Hsing Chen Y-MC, Smolen JS. FRI0164 incidence rate and characterization of herpes zoster in patients with moderate-to-severe rheumatoid arthritis: an update from baricitinib clinical studies. Ann Rheum Dis. 2019.
  • Mark C, Genovese JSS, Takeuchi T, et al. THU0078 safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Ann Rheum Dis. 2019;78(Suppl 2):308-9.
  • Lim CH, Chen HH, Chen YH, et al. The risk of tuberculosis disease in rheumatoid arthritis patients on biologics and targeted therapy: A 15-year real world experience in Taiwan. PLoS One. 2017;12:e0178035.
  • Scott IC, Hider SL, Scott DL. Thromboembolism with Janus Kinase (JAK) inhibitors for rheumatoid arthritis: how real is the risk? Drug Saf. 2018;41:645–653.
  • Taylor PC, Weinblatt ME, Burmester GR, et al. Cardiovascular safety during treatment with baricitinib in rheumatoid arthritis. Arthritis Rheumatol. 2019;71:1042–1055.
  • Kim SC, Schneeweiss S, Liu J, et al. Risk of venous thromboembolism in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013;65:1600–1607.
  • Xie F, Yun H, Bernatsky S, et al. Brief report: risk of gastrointestinal perforation among rheumatoid arthritis patients receiving tofacitinib, tocilizumab, or other biologic treatments. Arthritis Rheumatol. 2016;68:2612–2617.
  • Pharmaceutical_and_Medical_Devices_Agency. Pharmaceutical and medical devices agency report on the deliberation results. Smyraf Tablets 100 mg, Smyraf Tablets 50 mg; 2019 [cited 2020 Feb 20]. Available from: https://www.pmda.go.jp/drugs/2019/P20190419003/800126000_23100AMX00285_A100_1.pdf
  • Weinblatt ME, Keystone EC, 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.
  • van Vollenhoven RF, Emery P, Bingham CO 3rd, et al. Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients. Ann Rheum Dis. 2013;72:1496–1502.
  • Genovese MC, Rubbert-Roth A, Smolen JS, et al. Longterm safety and efficacy of tocilizumab in patients with rheumatoid arthritis: a cumulative analysis of up to 4.6 years of exposure. J Rheumatol. 2013;40:768–780.
  • Emery P, Burmester GR, Bykerk VP, et al. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis. 2015;74:19–26.
  • 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.
  • Stanley B, Cohen RVV, Winthrop K, et al. THU0167 safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the select phase 3 clinical program. Ann Rheum Dis. 2019;78(Suppl 2):357.
  • Besuyen R, Walker D, Winthrop K, et al. P597 pooled safety analyses from Phase 3 studies of filgotinib in patients with rheumatoid arthritis. J Crohn’s Colitis. 2020;14:S497–S8.
  • 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.
  • van der Heijde D, Klareskog L, Rodriguez-Valverde V, et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthritis Rheum. 2006;54:1063–1074. Available from http://www.pmda.go.jp/files/000226301.pdf.
  • Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26–37.
  • Pharmaceutical and medical devices agency report on the deliberation results; 2017. (Olumiant tablets 2 mg, Olumiant tablets 4 mg).
  • Curtis JR, Bykerk VP, Aassi M, et al. Adherence and persistence with methotrexate in rheumatoid arthritis: a systematic review. J Rheumatol. 2016;43:1997–2009.

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