-
1
-
-
84893772728
-
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update
-
Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492–509.
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 492-509
-
-
Smolen, J.S.1
Landewe, R.2
Breedveld, F.C.3
Buch, M.4
Burmester, G.5
Dougados, M.6
-
2
-
-
84859832981
-
2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis
-
Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012;64:625–39.
-
(2012)
Arthritis Care Res (Hoboken)
, vol.64
, pp. 625-639
-
-
Singh, J.A.1
Furst, D.E.2
Bharat, A.3
Curtis, J.R.4
Kavanaugh, A.F.5
Kremer, J.M.6
-
3
-
-
84960851952
-
The changing landscape of biosimilars in rheumatology
-
Dorner T, Strand V, Cornes P, Goncalves J, Gulacsi L, Kay J. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis 2016;75:974–82.
-
(2016)
Ann Rheum Dis
, vol.75
, pp. 974-982
-
-
Dorner, T.1
Strand, V.2
Cornes, P.3
Goncalves, J.4
Gulacsi, L.5
Kay, J.6
-
4
-
-
84923834669
-
Biosimilars: a cure to the U.S. health care cost conundrum?
-
Hirsch BR, Lyman GH. Biosimilars: a cure to the U.S. health care cost conundrum? Blood Rev 2014;28:263–8.
-
(2014)
Blood Rev
, vol.28
, pp. 263-268
-
-
Hirsch, B.R.1
Lyman, G.H.2
-
6
-
-
84998957734
-
A phase 1 pharmacokinetic study comparing SB5, an adalimumab biosimilar, and adalimumab reference product Humira
-
Shin D, Kim Y, Kim HS, Fuhr R, Körnicke T. A phase 1 pharmacokinetic study comparing SB5, an adalimumab biosimilar, and adalimumab reference product Humira. Ann Rheum Dis 2015;74 Suppl 2:459.
-
(2015)
Ann Rheum Dis
, vol.74
, pp. 459
-
-
Shin, D.1
Kim, Y.2
Kim, H.S.3
Fuhr, R.4
Körnicke, T.5
-
7
-
-
0023945481
-
The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis
-
Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315–24.
-
(1988)
Arthritis Rheum
, vol.31
, pp. 315-324
-
-
Arnett, F.C.1
Edworthy, S.M.2
Bloch, D.A.3
McShane, D.J.4
Fries, J.F.5
Cooper, N.S.6
-
8
-
-
0029044362
-
American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis
-
Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727–35.
-
(1995)
Arthritis Rheum
, vol.38
, pp. 727-735
-
-
Felson, D.T.1
Anderson, J.J.2
Boers, M.3
Bombardier, C.4
Furst, D.5
Goldsmith, C.6
-
9
-
-
0028815803
-
Modified disease activity scores that include twenty-eight–joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis
-
Prevoo ML, van ‘t Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. 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 1995;38:44–8.
-
(1995)
Arthritis Rheum
, vol.38
, pp. 44-48
-
-
Prevoo, M.L.1
van ‘t Hof, M.A.2
Kuper, H.H.3
van Leeuwen, M.A.4
van de Putte, L.B.5
van Riel, P.L.6
-
10
-
-
0030068817
-
Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis: comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism criteria
-
Van Gestel AM, Prevoo ML, van ‘t Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis: comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism criteria. Arthritis Rheum 1996;39:34–40.
-
(1996)
Arthritis Rheum
, vol.39
, pp. 34-40
-
-
Van Gestel, A.M.1
Prevoo, M.L.2
van ‘t Hof, M.A.3
van Rijswijk, M.H.4
van de Putte, L.B.5
van Riel, P.L.6
-
11
-
-
23944478301
-
Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score
-
Aletaha D, Nell VP, Stamm T, Uffmann M, Pflugbeil S, Machold K, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther 2005;7:R796–806.
-
(2005)
Arthritis Res Ther
, vol.7
, pp. R796-806
-
-
Aletaha, D.1
Nell, V.P.2
Stamm, T.3
Uffmann, M.4
Pflugbeil, S.5
Machold, K.6
-
12
-
-
0344127554
-
A Simplified Disease Activity Index for rheumatoid arthritis for use in clinical practice
-
Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A Simplified Disease Activity Index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford) 2003;42:244–57.
-
(2003)
Rheumatology (Oxford)
, vol.42
, pp. 244-257
-
-
Smolen, J.S.1
Breedveld, F.C.2
Schiff, M.H.3
Kalden, J.R.4
Emery, P.5
Eberl, G.6
-
13
-
-
2342658406
-
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
-
Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, 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.
-
(2004)
Arthritis Rheum
, vol.50
, pp. 1400-1411
-
-
Keystone, E.C.1
Kavanaugh, A.F.2
Sharp, J.T.3
Tannenbaum, H.4
Hua, Y.5
Teoh, L.S.6
-
14
-
-
0037231533
-
Adalimumab, a fully human anti–tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial
-
Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti–tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003;48:35–45.
-
(2003)
Arthritis Rheum
, vol.48
, pp. 35-45
-
-
Weinblatt, M.E.1
Keystone, E.C.2
Furst, D.E.3
Moreland, L.W.4
Weisman, M.H.5
Birbara, C.A.6
-
15
-
-
27544475840
-
-
July 2005
-
European Medicines Agency. Guideline on the choice of the non-inferiority margin. July 2005. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003636.pdf.
-
Guideline on the choice of the non-inferiority margin
-
-
-
17
-
-
84937604672
-
A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
-
Emery P, Vencovsky J, Sylwestrzak A, Leszczynski P, Porawska W, Baranauskaite A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2017;76:51–7.
-
(2017)
Ann Rheum Dis
, vol.76
, pp. 51-57
-
-
Emery, P.1
Vencovsky, J.2
Sylwestrzak, A.3
Leszczynski, P.4
Porawska, W.5
Baranauskaite, A.6
-
18
-
-
31044442965
-
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
-
Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, 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.
-
(2006)
Arthritis Rheum
, vol.54
, pp. 26-37
-
-
Breedveld, F.C.1
Weisman, M.H.2
Kavanaugh, A.F.3
Cohen, S.B.4
Pavelka, K.5
van Vollenhoven, R.6
-
19
-
-
33744479185
-
Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study
-
Weinblatt ME, Keystone EC, Furst DE, Kavanaugh AF, Chartash EK, Segurado OG. 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.
-
(2006)
Ann Rheum Dis
, vol.65
, pp. 753-759
-
-
Weinblatt, M.E.1
Keystone, E.C.2
Furst, D.E.3
Kavanaugh, A.F.4
Chartash, E.K.5
Segurado, O.G.6
-
20
-
-
85024905533
-
Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study
-
Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis 2017;76:1679–87.
-
(2017)
Ann Rheum Dis
, vol.76
, pp. 1679-1687
-
-
Cohen, S.1
Genovese, M.C.2
Choy, E.3
Perez-Ruiz, F.4
Matsumoto, A.5
Pavelka, K.6
-
21
-
-
85007373252
-
A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis
-
Jani RH, Gupta R, Bhatia G, Rathi G, Ashok Kumar P, Sharma R, et al. A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis 2016;19:1157–68.
-
(2016)
Int J Rheum Dis
, vol.19
, pp. 1157-1168
-
-
Jani, R.H.1
Gupta, R.2
Bhatia, G.3
Rathi, G.4
Ashok Kumar, P.5
Sharma, R.6
-
22
-
-
84903597970
-
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations
-
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J 2014;16:658–73.
-
(2014)
AAPS J
, vol.16
, pp. 658-673
-
-
Shankar, G.1
Arkin, S.2
Cocea, L.3
Devanarayan, V.4
Kirshner, S.5
Kromminga, A.6
-
23
-
-
79953906254
-
Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up
-
Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011;305:1460–8.
-
(2011)
JAMA
, vol.305
, pp. 1460-1468
-
-
Bartelds, G.M.1
Krieckaert, C.L.2
Nurmohamed, M.T.3
van Schouwenburg, P.A.4
Lems, W.F.5
Twisk, J.W.6
-
25
-
-
84928111749
-
Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis
-
Chen DY, Chen YM, Tsai WC, Tseng JC, Chen YH, Hsieh CW, et al. Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis. Ann Rheum Dis 2015;74:e16.
-
(2015)
Ann Rheum Dis
, vol.74
-
-
Chen, D.Y.1
Chen, Y.M.2
Tsai, W.C.3
Tseng, J.C.4
Chen, Y.H.5
Hsieh, C.W.6
-
26
-
-
75649121413
-
Response of elderly patients with rheumatoid arthritis to methotrexate or TNF inhibitors compared with younger patients
-
Koller MD, Aletaha D, Funovits J, Pangan A, Baker D, Smolen JS. Response of elderly patients with rheumatoid arthritis to methotrexate or TNF inhibitors compared with younger patients. Rheumatology (Oxford) 2009;48:1575–80.
-
(2009)
Rheumatology (Oxford)
, vol.48
, pp. 1575-1580
-
-
Koller, M.D.1
Aletaha, D.2
Funovits, J.3
Pangan, A.4
Baker, D.5
Smolen, J.S.6
-
27
-
-
84988431098
-
Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example
-
Lai Z, La Noce A. Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example. RMD Open 2016;2:e000154.
-
(2016)
RMD Open
, vol.2
-
-
Lai, Z.1
La Noce, A.2
|