References
- Helmick CG, Felson DT, Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: part I. Arthritis Rheum. 2008;58:15–25.
- Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016;388:2023–2038. published online May 3. DOI:10.1016/S0140-6736(16)30173-8.
- Alamanos Y, Voulgari PV, Drosos AA. Incidence and prevalence of rheumatoid arthritis, based on the 1987 American College of Rheumatology criteria: a systematic review. Semin Arthritis Rheum. 2006;36:182–188.
- Brooks PM. The burden of musculoskeletal disease – a global perspective. Clin Rheumatol. 2006;25(6):778–781.
- Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res. 2016;68(1):1–25.
- Pincus T. RAPID3, an index of only 3 patient self-report core data set measures, but not ESR, recognizes incomplete responses to methotrexate in usual care of patients with rheumatoid arthritis. Bull Hosp Jt Dis. 2013;71(2):117–120.
- Moreland LW, O’Dell JR, Paulus HE, et al. A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the treatment of Early Aggressive Rheumatoid Arthritis Trial. Arthritis Rheum. 2012;64(9):2824–2835.
- Papadopoulos NG, Alamanos Y, Papadopoulos IA, et al. Disease modifying antirheumatic drugs in early rheumatoid arthritis: a long-term observational study. J Rheumatol. 2002;29(2):261–266.
- Rosales Rosado Z, Leon L, Freites Nunez D, et al. Survival of disease-modifying antirheumatic drugs in rheumatoid arthritis [abstract]. Arthritis Rheumatol. 2016;68(suppl 10). [cited 2017 Mar 3]. Available from: http://acrabstracts.org/abstract/survival-of-disease-modifying-antirheumatic-drugs-in-rheumatoid-arthritis/.
- Tanaka Y, Martin Mola E. IL-6 targeting compared to TNF targeting in rheumatoid arthritis: studies of olokizumab, sarilumab and sirukumab. Ann Rheum Dis. 2014;73(9):1595–1597.
- Cohen SB, Moreland LW, Cush JJ, et al. A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate. Ann Rheum Dis. 2004;63(9):1062–1068.
- Maini RN, Taylor PC, Szechinski J, et al. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum. 2006;54(9):2817–2829.
- Baillet A, Gossec L, Paternotte S, et al. Evaluation of serum interleukin-6 level as a surrogate marker of synovial inflammation and as a factor of structural progression in early rheumatoid arthritis: results from a French national multicenter cohort. Arthritis Care Res. 2015;67(7):905–912.
- Yoshida Y, Tanaka T. Interleukin 6 and rheumatoid arthritis. Biomed Res Int. 2014;2014:1–12.
- Hashizume M, Mihara M. The roles of interleukin-6 in the pathogenesis of rheumatoid arthritis. Arthritis. 2011;2011:1–8.
- Hashizume M, Tan S-L, Takano J, et al. Tocilizumab, a humanized anti-IL-6R antibody, as an emerging therapeutic option for rheumatoid arthritis: molecular and cellular mechanistic insights. Int Rev Immunol. 2015;34(3):265–279.
- Kobelt G, Kasteng F. Access to innovative treatments in rheumatoid arthritis in Europe. European Federation of Pharmaceutical Industry Associations (EFPIA); 2009. [cited 2016 Nov 16]. Available from: http://www.comparatorreports.se/Access%20to%20RA%20Treatments%20October%202009.pdf.
- Taylor PC, Moore A, Vasilescu R, et al. A structured literature review of the burden of illness and unmet needs in patients with rheumatoid arthritis: a current perspective. Rheumatol Int. 2016;36(5):685–695.
- Dorner T, Strand V, Cornes P, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis. 2016;0:1–9. DOI:10.1136/annrheumdis-2016-209166
- Gabay C, Emery P, Vollenhoven R, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013;381(9877):1541–1550.
- Schiff M, Weinblatt ME, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014;73(1):86–94.
- Porter D, Van Melckebeke J, Dale J, et al. Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial. Lancet. 2016;388(10041):239–247.
- Febbraio MA, Pedersen BK. Muscle-derived interleukin-6: mechanisms for activation and possible biological roles. FASEB J. 2002;16(11):1335–1347.
- Scheller J, Chalaris A, Schmidt-Arras D, et al. The pro- and anti-inflammatory properties of the cytokine interleukin-6. Biochim Biophys Acta. 2011;1813(5):878–888.
- Bijlsma JWJ, Welsing PMJ, Woodworth TG, et al. Early rheumatoid arthritis treated with tocilizumab, methotrexate, or their combination (U-Act-Early): a multicentre, randomised, double-blind, double-dummy, strategy trial. Lancet. 2016;388(10042):343–355.
- Cooper S. Sarilumab for the treatment of rheumatoid arthritis. Immunotherapy. 2016;8(3):249–250.
- Mease PJ, Gottlieb AB, Berman A, et al. The efficacy and safety of clazakizumab, an anti-interleukin-6 monoclonal antibody, in a phase IIb study of adults with active psoriatic arthritis. Arthritis Rheumatol. 2016;68(9):2163–2173.
- Joachim RK. Emerging therapies for rheumatoid arthritis. Rheumatol Ther. 2016;3(1):31–42.
- Zhuang Y, De Vries DE, Xu Z, et al. Evaluation of disease-mediated therapeutic protein-drug interactions between an anti-interleukin-6 monoclonal antibody (sirukumab) and cytochrome P450 activities in a phase 1 study in patients with rheumatoid arthritis using a cocktail approach. J Clin Pharmacol. 2015;55(12):1386–1394.
- Xu Z, Bouman-Thio E, Comisar C, et al. Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study. Br J Clin Pharmacol. 2011;72(2):270–281.
- Zhuang Y, Xu Z, De Vries DE, et al. Pharmacokinetics and safety of sirukumab following a single subcutaneous administration to healthy Japanese and Caucasian subjects. Int J Clin Pharmacol Ther. 2013;51(3):187–199.
- Smolen JSWM, Zhuang Y, Shen S, et al. Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomized, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2014;73(9):1616–1625.
- Takeuchi T, Thorne C, Karpouzas G, et al. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis despite disease-modifying anti-rheumatic drug treatment. London (UK): EULAR; 2016. AbstractSAT0145.
- Aletaha D, Bingham C III, Tanaka Y, et al. Efficacy and Safety of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results from a Randomized, Double-Blind, Placebo-Controlled, Global, Phase 3 Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). [Cited 2017 Apr 5]. Available from: http://acrabstracts.org/abstract/efficacy-and-safety-of-sirukumab-an-anti-il-6-cytokine-monoclonal-antibody-in-patients-with-active-rheumatoid-arthritis-despite-anti-tnf-therapy-results-from-a-randomized-double-blind-pla/.
- Janssen Research & Development. A study comparing sirukumab (CNTO 136) monotherapy with adalimumab (HUMIRA) monotherapy in the treatment of active rheumatoid arthritis (SIRROUND-H). [cited 2016 Nov 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT02019472?term=NCT02019472&rank=1. NLM identifier: NCT01604343.
- Johnson&Johnson. New phase 3 monotherapy study of sirukumab versus humira and sirukumab data in an anti-TNF refractory population reported in the treatment of moderately to severely active rheumatoid arthritis. [cited 2016 Nov 27]. Available from: https://www.jnj.com/media-center/press-releases/new-phase-3-monotherapy-study-of-sirukumab-versus-humira-and-sirukumab-data-in-an-anti-tnf-refractory-population-reported-in-the-treatment-of-moderately-to-severely-active-rheumatoid-arthritis.
- Janssen Research & Development. A study of CNTO 136 (sirukumab), a human anti-IL-6 monoclonal antibody, administered subcutaneously, in patients with active rheumatoid arthritis despite anti-TNF-alpha therapy (SIRROUND-T). [cited 2016 Nov 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT01606761?term=NCT01606761&rank=1. NLM identifier: NCT01606761.
- Janssen Research & Development. A study of CNTO 136 (sirukumab) administered subcutaneously in Japanese patients with active rheumatoid arthritis unresponsive to methotrexate or sulfasalazine. [cited 2016 Nov 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT01689532?term=NCT01689532&rank=1. NLM identifier: NCT01689532.
- Janssen Research & Development. Long-term safety and efficacy of sirukumab in participants with RA completing studies CNTO136ARA3001 or CNTO136ARA3003 (SIRROUND-LTE). [cited 2016 Nov 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT01856309?term=NCT01856309&rank=1. NLM identifier: NCT01856309.
- Kitani A, Hara M, Hirose T, et al. Autostimulatory effects of IL-6 on excessive B cell differentiation in patients with systemic lupus erythematosus: analysis of IL-6 production and IL-6R expression. Clin Exp Immunol. 1992;88(1):75–83.
- Szepietowski JC, Nilganuwong S, Wozniacka A, et al. Phase I, randomized, double-blind, placebo-controlled, multiple intravenous, dose-ascending study of sirukumab in cutaneous or systemic lupus erythematosus. Arthritis Rheum. 2013;65(10):2661–2671.
- Rovin B, Van Vollenhoven R, Aranow C, et al. A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of treatment with sirukumab (CNTO 136) in patients with active lupus nephritis. Arthritis Rheumatol. 2016;68(9):2174–2183.
- Guillevin L, Régent A. Treating giant-cell arteritis: is IL-6 the cytokine to target? Lancet. 2016;387(10031):1882–1883.
- GlaxoSmithKline. Efficacy and safety study of sirukumab in patients with giant cell arteritis. [cited 2016 Nov 27]. Available from: https://clinicaltrials.gov/ct2/show/NCT02531633?term=NCT02531633&rank=1. NLM identifier: NCT02531633.
- Dowlati Y, Herrmann N, Swardfager W, et al. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010;67(5):446–457.
- Hsu B, Wang D, Sun Y, et al. Improvement in measures of depressed mood and anhedonia, and fatigue, in a randomized, placebo-controlled, phase 2 study of sirukumab, a human anti-interleuin-6 antibody, in patients with rheumatoid arthritis. Ann Rheum Dis. 2015;74(Suppl 2):720–721.
- Giles JT, Sattar N, Gabriel SE, et al. Comparative cardiovascular safety of tocilizumab vs. etanercept in rheumatoid arthritis: results of a randomized, parallel-group, multicenter, noninferiority, phase IV clinical trial [abstract]. Arthritis Rheumatol. 2016;68(Suppl10). [cited 2016 Nov 30]. Available from: http://acrabstracts.org/abstract/comparative-cardiovascular-safety-of-tocilizumab-vs-etanercept-in-rheumatoid-arthritis-results-of-a-randomized-parallel-group-multicenter-noninferiority-phase-4-clinical-trial/.