Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial

The Lancet - Tập 381 Số 9877 - Trang 1541-1550 - 2013
Cem Gabay1, Paul Emery2, Ronald van Vollenhoven3, Ara Dikranian4, Rieke Alten5, Karel Pavelká6, Micki Klearman7, David Musselman7, Sunil Agarwal7, Jennifer Green8, Arthur Kavanaugh9
1University Hospitals of Geneva, Geneva, Switzerland
2University of Leeds, Leeds, UK
3Karolinska Institute, Stockholm, Sweden.
4San Diego Arthritis Medical Clinic, San Diego, CA, USA
5University of Berlin, Berlin, Germany
6Research Institute of Rheumatic Diseases, Prague, Czech Republic
7Genentech, South San Francisco, CA, USA
8Roche, Welwyn, UK
9University of California, San Diego, CA, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

Salliot, 2009, Long term safety of methotrexate monotherapy in rheumatoid arthritis patients: a systematic literature research, Ann Rheum Dis, 68, 1100, 10.1136/ard.2008.093690

Goudie, 2012, How well do patients with rheumatoid and psoriatic arthritis tolerate methotrexate? A retrospective review of discontinuation data from a large UK cohort, Arthritis Rheum, 64, S560

Cannon, 2011, Merging Veterans Affairs rheumatoid arthritis registry and pharmacy data to assess methotrexate adherence and disease activity in clinical practice, Arthritis Care Res, 63, 1680, 10.1002/acr.20629

de Thurah, 2010, Compliance with methotrexate treatment in patients with rheumatoid arthritis: influence of patients' beliefs about the medicine: a prospective cohort study, Rheumatol Int, 30, 1441, 10.1007/s00296-009-1160-8

Grijalva, 2010, Adherence to disease-modifying antirheumatic drugs and the effects of exposure misclassification on the risk of hospital admission, Arthritis Care Res, 62, 730, 10.1002/acr.20087

Heiberg, 2008, The comparative one-year performance of anti-tumor necrosis factor alpha drugs in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: results from a longitudinal, observational, multicenter study, Arthritis Rheum, 59, 234, 10.1002/art.23333

Soliman, 2011, Impact of concomitant use of DMARDs on the persistence with anti-TNF therapies in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register, Ann Rheum Dis, 70, 583, 10.1136/ard.2010.139774

Listing, 2006, Clinical and functional remission: even though biologics are superior to conventional DMARDs overall success rates remain low—results from RABBIT, the German biologics register, Arthritis Res Ther, 8, R66, 10.1186/ar1933

Askling, 2007, Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists, Ann Rheum Dis, 66, 1339, 10.1136/ard.2006.062760

Mariette, 2011, Registries in rheumatoid arthritis and autoimmune diseases: data from the French registries, Rheumatology, 50, 222, 10.1093/rheumatology/keq368

Lee, 2009, Utilization trends of tumor necrosis factor inhibitors among patients with rheumatoid arthritis in a United States observational cohort study, J Rheumatol, 36, 1611, 10.3899/jrheum.080889

Yazici, 2008, Utilization of biologic agents in rheumatoid arthritis in the United States: analysis of prescribing patterns in 16,752 newly diagnosed patients and patients new to biologic therapy, Bull NYU Hosp Joint Dis, 66, 77

Dayer, 2010, Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor, Rheumatology, 49, 15, 10.1093/rheumatology/kep329

Gottenberg, 2012, Serum IL-6 and IL-21 are associated with markers of B cell activation and structural progression in early rheumatoid arthritis: results from the ESPOIR cohort, Ann Rheum Dis, 71, 1243, 10.1136/annrheumdis-2011-200975

Tak, 1997, Analysis of the synovial cell infiltrate in early rheumatoid synovial tissue in relation to local disease activity, Arthritis Rheum, 40, 217, 10.1002/art.1780400206

Mihara, 2005, Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family, Int Immunopharmacol, 5, 1731, 10.1016/j.intimp.2005.05.010

Nishimoto, 2008, Humanized antihuman IL-6 receptor antibody, tocilizumab, Handb Exp Pharmacol, 181, 151, 10.1007/978-3-540-73259-4_7

Emery, 2008, IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial, Ann Rheum Dis, 67, 1516, 10.1136/ard.2008.092932

Smolen, 2008, Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial, Lancet, 371, 987, 10.1016/S0140-6736(08)60453-5

Genovese, 2008, Arthritis Rheum, 58, 2968, 10.1002/art.23940

Kremer, 2011, Arthritis Rheum, 63, 609, 10.1002/art.30158

Jones, 2010, Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study, Ann Rheum Dis, 69, 88, 10.1136/ard.2008.105197

Nishimoto, 2007, Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab, Ann Rheum Dis, 66, 1162, 10.1136/ard.2006.068064

Nishimoto, 2009, Mod Rheumatol, 19, 12, 10.3109/s10165-008-0125-1

Weinblatt, 2011, Tocilizumab monotherapy and tocilizumab plus disease-modifying antirheumatic drugs in a US rheumatoid arthritis population with inadequate response to anti-tumor necrosis factor agents, Arthritis Rheum, 63, S162

Dougados, 2013, Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY), Ann Rheum Dis, 72, 43, 10.1136/annrheumdis-2011-201282

Prevoo, 1995, Modified disease activity scores that include twenty-eight-joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis, Arthritis Rheum, 38, 44, 10.1002/art.1780380107

Felson, 1995, American College of Rheumatology: preliminary definition of improvement in rheumatoid arthritis, Arthritis Rheum, 38, 727, 10.1002/art.1780380602

van Riel, 1996, Development and validation of response criteria in rheumatoid arthritis: steps towards an international consensus on prognostic markers, Br J Rheumatol, 35, 4, 10.1093/rheumatology/35.suppl_2.4

Fries, 1982, The dimensions of health outcomes: the Health Assessment Questionnaire, disability and pain scales, J Rheumatol, 9, 789

Fries, 1980, Measurement of patient outcome in arthritis, Arthritis Rheum, 23, 137, 10.1002/art.1780230202

Felson, 2011, American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials, Ann Rheum Dis, 70, 404, 10.1136/ard.2011.149765

Cella, 2005, Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis, J Rheumatol, 32, 811

Ware, 1992, The MOS 36-Item Short-Form Health Survey (SF-36): I: conceptual framework and item selection, Med Care, 30, 473, 10.1097/00005650-199206000-00002

2001, Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), JAMA, 2815, 2486

Van de Putte, 2004, Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed, Ann Rheum Dis, 63, 508, 10.1136/ard.2003.013052

2010

2011, RoActemra® (tocilizumab) (summary of product characteristics)

Fleischmann, 2012, Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs, Arthritis Rheum, 64, 617, 10.1002/art.33383