Biologic and oral disease-modifying antirheumatic drug monotherapy in rheumatoid arthritis

Annals of the Rheumatic Diseases

Volumn 72, Issue 12, 2013, Pages 1897-1904

  Emery, Paul ^a,b   Sebba, Anthony ^c   Huizinga, Tom W J ^d  

^a UNIVERSITY OF LEEDS   (United Kingdom)

^b LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

^c UNIVERSITY OF SOUTH FLORIDA   (United States)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ADALIMUMAB; ANTIEMETIC AGENT; ANTINUCLEAR ANTIBODY; AZATHIOPRINE; BIOLOGICAL PRODUCT; BUCILLAMINE; CERTOLIZUMAB PEGOL; DISEASE MODIFYING ANTIRHEUMATIC DRUG; DOUBLE STRANDED DNA ANTIBODY; DRUG ANTIBODY; ETANERCEPT; FOLIC ACID; GOLIMUMAB; INFLIXIMAB; LEFLUNOMIDE; MERCAPTOPURINE; METHOTREXATE; MIZORIBINE; PENICILLAMINE; PLACEBO; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB; SALAZOSULFAPYRIDINE; TOCILIZUMAB; TOFACITINIB; TUMOR NECROSIS FACTOR INHIBITOR;

ANTIBODY PRODUCTION; ARTICLE; COMBINATION CHEMOTHERAPY; COST EFFECTIVENESS ANALYSIS; CYTOPENIA; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG COMPETITION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; GASTROINTESTINAL SYMPTOM; HUMAN; LIVER DISEASE; MONOTHERAPY; NAUSEA AND VOMITING; PATIENT COMPLIANCE; PNEUMONIA; PRESCRIPTION; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; SKIN DISEASE; UNSPECIFIED SIDE EFFECT;

DMARDS (BIOLOGIC); RHEUMATOID ARTHRITIS; TREATMENT;

ADMINISTRATION, ORAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL PRODUCTS; DRUG THERAPY, COMBINATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; METHOTREXATE; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84887426711     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2013-203485     Document Type: Article

References (131)

1. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010;69:964-75.
2. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008;59:762-84.
3. Klareskog L, Van Der Heijde D, De Jager JP, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004;363:675-81.
4. Van Der Heijde D, Klareskog L, Landewe R, et al. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum 2007;56:3928-39.
5. Keystone EC, Kavanaugh AF, Sharp JT, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004;50:1400-11.
6. Maini RN, Breedveld FC, Kalden JR, et al. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum 2004;50:1051-65.
7. Maini R, St Clair EW, Breedveld F, et al. Infliximab (chimeric anti-tumor necrosis factor a monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomized phase III trial. Lancet 1999;354:1932-9.
8. Lipsky PE, Van Der Heijde DM, St Clair EW, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis: anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. N Engl J Med 2000;343:1594-602.
9. 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;65:753-9.
10. Smolen JS, Han C, Bala M, et al. Evidence of radiographic benefit of treatment with infliximab plus methotrexate in rheumatoid arthritis patients who had no clinical improvement: a detailed subanalysis of data from the anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study. Arthritis Rheum 2005;52:1020-30.
11. Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003;48:35-45.
12. Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999;340:253-9.
13. Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41:1552-63.
14. 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.
15. Breedveld FC, Keystone E, Van Der Heijde D, et al. Initial combination therapy with adalimumab plus methotrexate leads to better long-term outcomes than with either monotherapy in patients with early rheumatoid arthritis: 8-Year results of an open-label extension of a phase 3 trial. Annual Meeting of the American College of Rheumatology and the ARHP, Chicago, IL, 5-9 Nov. 2011.
16. Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor alpha given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis 2009;68:789-96.
17. 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;54:1063-74.
18. Buckley F, Finckh A, Huizinga T W J, et al. Comparative efficacy of biologics as monotherapy and in combination with methotrexate in rheumatoid arthritis patients with an inadequate response to conventional dmards: a network meta-analysis. Arthritis Rheum 2012;64:S918.
19. Smolen J, Landewe RB, Mease P, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study: a randomised controlled trial. Ann Rheum Dis 2009;68:797-804.
20. Keystone E, Van Der Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 2008;58:3319-29.
21. Fleischmann R, Vencovsky J, Van Vollenhoven R, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis 2009;68:805-11.
22. Edwards J C W, Szczepanski L, Szechinski J, et al. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med 2004;350:2572-81.
23. Heiberg MS, Koldingsnes W, Mikkelsen K, et al. 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 2008;59:234-40.
24. Soliman MM, Ashcroft DM, Watson KD, et al. 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 2011;70:583-9.
25. Listing J, Strangfeld A, Rau R, et al. 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 2006;8:R66.
26. Askling J, Fored CM, Brandt L, et al. Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists. Ann Rheum Dis 2007;66:1339-44.
27. Mariette X, Gottenberg JE, Ravaud P, et al. Registries in rheumatoid arthritis and autoimmune diseases: data from the French registries. Rheumatology (Oxford) 2011;50:222-9.
28. Lee SJ, Chang H, Yazici Y, et al. Utilization trends of tumor necrosis factor inhibitors among patients with rheumatoid arthritis in a United States observational cohort study. J Rheumatol 2009;36:1611-17.
29. Yazici Y, Shi N, John A. 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 Jt Dis 2008;66:77-85.
30. Markham A, Lamb HM. Infliximab: a review of its use in the management of rheumatoid arthritis. Drugs 2000;59:1341-59.
31. Janssen Biotech Inc. REMICADE (infliximab) lyophilized concentrate for injection, for intravenous use. Horsham, PA: Janssen Biotech Inc, 2011.
32. Abbott Laboratories. HUMIRA (Adalimumab) injection, solution for subcutaneuous use. North Chicago, IL: Abbott Laboratories, 2012.
33. Wolbink GJ, Vis M, Lems W, et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 2006;54:711-15.
34. Garces S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis 2013;72:1947-55.
35. Mori S. A relationship between pharmacokinetics (PK) and the efficacy of infliximab for patients with rheumatoid arthritis: characterization of infliximab-resistant cases and PK-based modified therapy. Mod Rheumatol 2007;17:83-91.
36. Atzeni F, Sarzi-Puttini P. Autoantibody production in patients treated with anti-TNF-alpha. Exp Rev Clin Immunol 2008;4:275-80.
37. Yukawa N, Fujii T, Kondo-Ishikawa S, et al. Correlation of antinuclear antibody and anti-double-stranded DNA antibody with clinical response to infliximab in patients with rheumatoid arthritis: a retrospective clinical study. Arthritis Res Ther 2011;13:R213.
38. Eriksson C, Engstrand S, Sundqvist KG, et al. Autoantibody formation in patients with rheumatoid arthritis treated with anti-TNF alpha. Ann Rheum Dis 2005;64:403-7.
39. Charles PJ, Smeenk RJ, De Jong J, et al. Assessment of antibodies to double-stranded DNA induced in rheumatoid arthritis patients following treatment with infliximab, a monoclonal antibody to tumor necrosis factor alpha: findings in open-label and randomized placebo-controlled trials. Arthritis Rheum 2000;43:2383-90.
40. Kameda H, Kanbe K, Sato E, et al. Etanercept (ETN) plus methotrexate (MTX) combinatioin therapy resulted in a better outcome in joint damage and physical function than ETN monotherapy even in patients with active rheumatoid arthritis despite MTX treatment: 52 week results form the JESMR study. Ann Rheum Dis 2009:68:121.
41. Kameda H, Kanbe K, Sato E, et al. Etanercept (ETN) plus methotrexate (MTX) combination thereapy resulted in better clinical and radiographic outcomes than ETN monotherapy even in patients with active rheumatoid arthritis despite MTX treatment: 104-week results from the JESMR study. Ann Rheum Dis 2010;69:204.
42. Van Dartel S, Fransen J, Kievet W. Discontinuation of DMARDs in patients with rheumatoid arthritis treated with tumor necrosis factor blocking agents: an analysis in the Dutch Rheumatoid Arthritis Monitoring (DREAM) Registry. Arthritis Rheum 2011;63:S1019.
43. Dale J, Porter D. Pharmacotherapy: concepts of pathogenesis and emerging treatments. Optimising the strategy of care in early rheumatoid arthritis. Best Pract Res Clin Rheumatol 2010;24:443-55.
44. Pappas DA, Reed GW, John A, et al. Predictors of initiating biologic monotherapy in biologic naïve patients with rheumatoid arthritis (RA) in a US registry population. Arthritis Rheum 2012;64:S214.
45. Engel-Nitz NM, Ogale S, Kulakodlu M. Use of anti-tumor necrosis factor monotherapy and adherence with non-biologic disease-modifying anti-rheumatic drugs in combination with anti-tumor necrosis factor therapy among rheumatoid arthritis patients in a real-world setting. Arthritis Rheum 2012;64:S165.
46. DAVA Pharmaceuticals, Inc. Rheumatrex® (methotrexate tablets, USP). Fort Lee, NJ: DAVA Pharmaceuticals, Inc, 2009.
47. Salliot C, Van Der Heijde D. Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research. Ann Rheum Dis 2009;68:1100-4.
48. Shergy WJ, Polisson RP, Caldwell DS, et al. Methotrexate-associated hepatotoxicity: retrospective analysis of 210 patients with rheumatoid arthritis. Am J Med 1988;85:771-4.
49. Gochuico BR, Avila NA, Chow CK, et al. Progressive preclinical interstitial lung disease in rheumatoid arthritis. Arch Intern Med 2008;168:159-66.
50. Visser K, Katchamart W, Loza E, et al. Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative. Ann Rheum Dis 2009;68:1086-93.
51. Fitzpatrick JD, Goudie CT, Badcock A, et al. How well do patients with rheumatoid arthritis tolerate methotrexate? A retrospective review of discontinuation data from a large UK cohort. EULAR Annual Meeting, 6-9 June 2012, Berlin, Germany, 2012.
52. Schnabel A, Gross WL. Low-dose methotrexate in rheumatic diseases-efficacy, side effects, and risk factors for side effects. Semin Arthritis Rheum 1994;23:310-27.
53. Alarcon GS, Tracy IC, Strand GM, et al. Survival and drug discontinuation analyses in a large cohort of methotrexate treated rheumatoid arthritis patients. Ann Rhuem Dis 1995;54:708-12.
54. Benucci M, Saviola G, Manfredi M, et al. Cost effectiveness analysis of disease-modifying antirheumatic drugs in rheumatoid arthritis: a systematic review literature. Int J Rheumatol 2011;2011:845496.
55. Aletaha D, Stamm T, Kapral T, et al. Survival and effectiveness of leflunomide compared with methotrexate and sulfasalazine in rheumatoid arthritis: a matched observational study. Ann Rheum Dis 2003;62:944-51.
56. De La Mata J, Blanco FJ, Gomez-Reino JJ. Survival analysis of disease modifying antirheumatic drugs in Spanish rheumatoid arthritis patients. Ann Rheum Dis 1995;54:881-5.
57. Grove ML, Hassell AB, Hay EM, et al. Adverse reactions to disease-modifying anti-rheumatic drugs in clinical practice. QJM 2001;94:309-19.
58. Papadopoulos NG, Alamanos Y, Papadopoulos IA, et al. Disease modifying antirheumatic drugs in early rheumatoid arthritis: a long-term observational study. J Rheumatol 2002;29:261-6.
59. Galindo-Rodriguez G, Vina-Zubieta JA, Russell AS, et al. Disappointing long-term results with disease modifying antirheumatic drugs: a practice based study. J Rheumatol 1999;26:2337-43.
60. Morand EF, McCloud PI, Littlejohn GO. Life table analysis of 879 treatment episodes with slow acting antirheumatic drugs in community rheumatology practice. J Rheumatol 1992;19:704-8.
61. Verstappen SM, Bakker MF, Heurkens AH, et al. Adverse events and factors associated with toxicity in patients with early rheumatoid arthritis treated with methotrexate tight control therapy: the CAMERA study. Ann Rheum Dis 2010;69:1044-8.
62. DeNoon D. WebMD Survey: the lies we tell our doctors: 45% of WebMD readers don't tell their doctors the (whole) truth. 21 Sept 2004. http://www.medicinenet.com/script/main/art.asp?articlekey=46985 (accessed 1 Feb. 2013).
63. Choquette D, Arundine M, Thomas OC. Large discrepancy between expected and observed ratios of biologic treated rheumatoid arthritis patients also compliant on DMARDS. Ann Rheum Dis 2011;70:197.
64. Choquette D, Thomas O, Arundine M. Lower than expected levels of DMARD acquisition immediately pre and post biologic initiation in rheumatold arthritis patients. Arthritis Rheum 2012;64:S783.
65. Pavy S, Constantin A, Pham T, et al. Methotrexate therapy for rheumatoid arthritis: clinical practice guidelines based on published evidence and expert opinion. Joint Bone Spine 2006;73:388-95.
66. Mouterde G, Baillet A, Gaujoux-Viala C, et al. Optimizing methotrexate therapy in rheumatoid arthritis: a systematic literature review. Joint Bone Spine 2011;78:587-92.
67. Mainman H, McClaren E, Heycock C, et al. When should we use parenteral methotrexate? Clin Rheumatol 2010;29:1093-8.
68. Lambert CM, Sandhu S, Lochhead A, et al. Dose escalation of parenteral methotrexate in active rheumatoid arthritis that has been unresponsive to conventional doses of methotrexate: a randomized, controlled trial. Arthritis Rheum 2004;50:364-71.
69. Verstappen SM, Hyrich KL. Methotrexate for rheumatoid arthritis: a guide from Canada. J Rheumatol 2010;37:1374-6.
70. Liakos A, Batley M, Hammond T, et al. Subcutaneous methotrexate is more efficacious and better tolerated than oral methotrexate: the experience of a large group of patients in the rheumatology department of a district general hospital. Ann Rheum Dis 2012;71:672.
71. Braun J, Kastner P, Flaxenberg P, et al. Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis: results of a six-month, multicenter, randomized, double-blind, controlled, phase IV trial. Arthritis Rheum 2008;58:73-81.
72. Hoekstra M, Haagsma C, Neef C, et al. Splitting high-dose oral methotrexate improves bioavailability: a pharmacokinetic study in patients with rheumatoid arthritis. J Rheumatol 2006;33:481-5.
73. Pandya S, Aggarwal A, Misra R. Methotrexate twice weekly vs once weekly in rheumatoid arthritis: a pilot double-blind, controlled study. Rheumatol Int 2002;22:1-4.
74. Prey S, Paul C. Effect of folic or folinic acid supplementation on methotrexate-associated safety and efficacy in inflammatory disease: a systematic review. Br J Dermatol 2009;160:622-8.
75. Devlin J, Wagstaff K, Arthur V, et al. Granisetron (Kytril) suppresses methotrexateinduced nausea and vomiting among patients with inflammatory arthritis and is superior to prochlorperazine (Stemetil). Rheumatology (Oxford) 1999;38:280-2.
76. Chatzidionysiou K, Lie E, Nasonov E, et al. Effectiveness of disease-modifying antirheumatic drug co-therapy with methotrexate and leflunomide in rituximab-treated rheumatoid arthritis patients: results of a 1-year follow-up study from the CERERRA collaboration. Ann Rheum Dis 2012;71:374-7.
77. Henes JC, Schedel J, Kanz L, et al. Rituximab and concomitant leflunomide for the treatment of rheumatoid arthritis. Rheumatol Int 2010;30:709-12.
78. Bingham SJ, Buch MH, Kerr MA, et al. Induction of antinuclear antibodies in patients with rheumatoid arthritis treated with infliximab and leflunomide. Arthritis Rheum 2004;50:4072-3.
79. Weinblatt ME, Kremer J, Cush J, et al. Tocilizumab as monotherapy or in combination with nonbiologic DMARDs: 24-week results of an open-label, clinical practice study (ACT-STAR). Arthritis Care Res 2013;65:362-71.
80. Weinblatt M, Combe B, Covucci A, et al. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs: a one-year randomized, placebo-controlled study. Arthritis Rheum 2006;54:2807-16.
81. Amgen Inc, Wyeth Pharmaceuticals. Enbrel® (etanercept) for subcutaneous injection. Thousand Oaks, CA: Amgen Inc. and Wyeth Pharmaceuticals, 2009.
82. Pfizer Limited. Enbrel 25 mg powder and solvent for solution for injection. 2012. Kent, UK: Pfizer Limited.
83. Abbott Laboratories Ltd. Humira 40 mg solution for injection [summary of product characteristics]. Berkshire, UK: Abbott Laboratories Ltd, 2010.
84. Abbott Laboratories Ltd. Humira 40 mg/0.8 ml solution for injection for paediatric use. Berkshire, UK: Abbott Laboratories Ltd, 2012.
85. UCB, Inc. Cimzia® (certolizumab pegol). Smyrna, GA: UCB, Inc, 2009.
86. UCB Pharma SA. Cimzia 200 mg solution for injection. Brussels, Belgium: UCB Pharma SA, 2012.
87. Centocor, Inc. Remicade® (infliximab). Malvern, PA: Centocor, Inc, 2009.
88. Janssen Biologics, B. V. Remicade 100 mg powder for concentrate for solution for infusion. Leiden, The Netherlands: Janssen Biologics, BV, 2012.
89. Centocor Ortho Biotech Inc. Simponi (golimumab). Horsham, PA: Centocor Ortho Biotech Inc, 2009.
90. Janssen Biologics, B. V. Simponi 50 mg solution for injection in pre-filled pen. The Netherlands: Janssen Biologics, BV, 2012.
91. Genentech, Inc. Actemra® (tocilizumab) injection for intravenous infusion. South San Francisco, CA: Genentech, Inc, 2012.
92. Roche Registration Limited. RoACTEMRA 20 mg/ml concentrate for solution for infusion. Welwyn Garden City, UK: Roche Registration Limited, 2012.
93. Pfizer Ltd. XELJANZ ® (tofacitinib) tablets for oral administration Initial U. S. Approval: 2012. New York, NY: Pfizer Labs, 2012.
94. Amgen Inc. Kineret® (anakinra). Thousand Oaks, CA: Amgen Inc, 2001.
95. Bristol-Myers Squibb Pharma EEIG. Orencia® 250 mg powder for concentrate for solution for infusion [summary of product characteristics]. Uxbridge, UK: Bristol-Meyers Squibb Pharma EEIG, 2009.
96. Bristol-Myers Squibb Pharma EEIG. ORENCIA 250 mg powder for concentrate for solution for infusion. Uxbridge, UK: 2012.
97. Genentech, Inc. Rituxan® (rituximab). South San Francisco, CA: Genentec, 2009.
98. Roche Registration Limited. MabThera 100 mg concentrate for solution for infusion. Welwyn Garden City, UK: Roche Registration Limited, 2012.
99. Pappas DA, Reed GW, Saunders KC, et al. Characteristics associated with biologic initiation as monotherapy versus combination therapy in patients with rheumatoid arthritis (RA) in a US registry population. Arthritis Rheum 2012;64:S557.
100. Van De Putte L B A, Atkins C, Malaise M, et al. 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 2004;63:508-16.
101. Keystone EC, Breedveld FC, Kupper H, et al. Long-term use of adalimumab as monotherapy following attainment of low-disease activity: subanalysis of the open-label extension of PREMIER. Ann Rheum Dis 2012;71:664.
102. Combe B, Codreanu C, Fiocco U, et al. Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison. Ann Rheum Dis 2006;65:1357-62.
103. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93.
104. Genovese MC, Bathon JM, Martin RW, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum 2002;46:1443-50.
105. Kameda H, Ueki Y, Saito K, et al. Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial. Mod Rheumatol 2010;20:531-8.
106. Kameda H, Kanbe K, Sato E, et al. Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon starting etanercept in patients with rheumatoid arthritis: 52-week results from the JESMR study. J Rheumatol 2011;38:1585-92.
107. Van Riel PL, Taggart AJ, Sany J, et al. Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study. Ann Rheum Dis 2006;65:1478-83.
108. Emery P, Fleischmann RM, Moreland LW, et al. Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum 2009;60:2272-83.
109. Kremer J, Ritchlin C, Mendelsohn A, et al. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum 2010;62:917-28.
110. Weinblatt ME, Fleischmann R, Van Vollenhoven R, et al. Certolizumab pegol as monotherapy or with concomitant DMARDS in patients with active rheumatoid arthritis (RA) with or without prior TNF inhibitor use: analysis of the realistic 12-week phase IIIB randomized controlled study. Ann Rheum Dis 2011;70:414.
111. Moreland LW, Alten R, Van Den Bosch F, et al. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double-blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion. Arthritis Rheum 2002;46:1470-9.
112. Schiff M, Pritchard C, Huffstutter JE, et al. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis 2009;68:1708-14.
113. Bresnihan B, Varo-Gracia JM, Cobby M, et al. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 1998;41:2196-204.
114. Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis 2010;69:88-96.
115. Nishimoto N, Miyasaka N, Yamamoto K, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol 2009;19:12-19.
116. Jones G, Sebba A, Leply D, et al. Long-term efficacy of tocilizumab monotherapy in patients with rheumatoid arthritis previously methotrexate free for 6 months. Arthritis Rheum 2012;64:S197.
117. Nishimoto N, Hashimoto J, Miyasaka N, et al. 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 2007;66:1162-7.
118. Hashimoto J, Garnero P, Van Der Heijde D, et al. Humanized anti-interleukin-6-receptor antibody (tocilizumab) monotherapy is more effective in slowing radiographic progression in patients with rheumatoid arthritis at high baseline risk for structural damage evaluated with levels of biomarkers, radiography, and BMI: data from the SAMURAI study. Mod Rheumatol 2011;21:10-15.
119. Dougados M, Kissel K, Sheeran T, et al. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2 year randomized controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis 2013;72:43-50.
120. Dougados M, Kissel K, Conaghan PG, et al. Clinical, radiographic, and immunogenic effects after 1 year of tocilizumab based treatment strategy with and without methotrexate in rheumatoid arthritis: the ACT RAY Study. Arthritis Rheum 2012;64:S1077.
121. Dougados M, Kissel K, Conaghan PG, et al. Clinical, radiographic, and immunogenic effects after 1 year of tocilizumab (TCZ)-based treatment strategy with and without methotrexate (MTX) in rheumatoid arthritis (RA): the ACT-RAY study-poster tours. Ann Rheum Dis 2012;71(suppl 3):185.
122. Sibilia J, Graninger W, Ostor A, et al. Comparison of tocilizumab as monotherapy or with add-on DMARDS in patients with rheumatoid arthritis and an inadequate response to previous treatments: ACT-SURE results. Ann Rheum Dis 2011;70:466.
123. Nishimoto N, Miyasaka N, Yamamoto K, et al. Long-term safety and efficacy of tocilizumab, an anti-interleukin-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis 2008;68:1580-4.
124. Gabay C, Emery P, Van 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;381:1541-50.
125. Navarro-Millan I, Singh JA, Curtis JR. Systematic review of tocilizumab for rheumatoid arthritis: a new biologic agent targeting the interleukin-6 receptor. Clin Ther 2012;34:788-802.
126. Nishimoto N, Ito K, Takagi N. Safety and efficacy profiles of tocilizumab monotherapy in Japanese patients with rheumatoid arthritis: meta-analysis of six initial trials and five long-term extensions. Mod Rheumatol 2010;20:222-32.
127. Weinblatt E, Kremer JM, Cush JJ, et al. 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 2011;63:S162.
128. Takeuchi T, Harigai M, Tanaka Y, et al. Golimumab, a human anti-TNF monoclonal antibody, administered subcutaneously every four weeks as monotherapy in patients with active rheumatoid arthritis despite DMARD therapy: a 52 week results of clinical, radiographic and pharmacokinetic assessments. EULAR Annual Meeting, 6-9 June 2012, Berlin, Germany.
129. Takeuchi T, Harigai M, Tanaka Y, et al. Golimumab, a human anti-TNF monoclonal antibody, administered subcutaneously every four weeks as monotherapy in patients with active rheumatoid arthritis despite disease modifying antirheumatic drug therapy: week 104 results of clinical, radiographic and safety assessments. Arthritis Rheum 2012;64(Suppl 10):1324.
130. Durez P, Depresseux G, Avaux M, et al. Remission induction in early active rheumatoid arthritis: comparison of tocilizumab versus methotrexate monotherapy. Arthritis Rheum 2012;64:S333.
131. Izumi K, Kaneko Y, Yasuoka H, et al. Lack of additive benefits of concomitant methotrexate use to tocilizumab monotherapy for rheumatoid arthritis in daily clinical practice. Arthritis Rheum 2012;64:S197.