Tabalumab in rheumatoid arthritis patients with an inadequate response to methotrexate and naive to biologic therapy: A phase II, randomized, placebo-controlled trial

Arthritis and Rheumatism

Volumn 65, Issue 4, 2013, Pages 880-889

  Genovese, M C ^a   Bojin, S ^b   Biagini, I M ^c   Mociran, E ^b   Cristei, D ^d   Mirea, G ^e   Georgescu, L ^b   Sloan Lancaster, J ^f  

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^b Paediatric Surgery and Orthopaedics Department   (Romania)

^c Department of Rheumatology   (Romania)

^d Rheumatology Center   (Romania)

^e Brasov County Hospital   (Romania)

^f ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CD20 ANTIGEN; CD27 ANTIGEN; IMMUNOGLOBULIN A; IMMUNOGLOBULIN D; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; METHOTREXATE; TABALUMAB;

ADULT; AGED; ARTICLE; B LYMPHOCYTE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; TREATMENT RESPONSE;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; B-CELL ACTIVATING FACTOR; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84875715149     PISSN: 00043591     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.37820     Document Type: Article

References (23)

1. Silverman GJ, Carson DA,. Roles of B cells in rheumatoid arthritis. Arthritis Res Ther 2003; 5 Suppl 4: S1-S6.
2. Mackay F, Ambrose C,. The TNF family members BAFF and APRIL: the growing complexity. Cytokine Growth Factor Rev 2003; 14: 311-24.
3. Mackay F, Silveira PA, Brink R,. B cells and the BAFF/APRIL axis: fast-forward on autoimmunity and signaling. Curr Opin Immunol 2007; 19: 327-36.
4. Lindenau S, Scholze S, Odendahl M, Dorner T, Radbruch A, Burmester GR, et al. Aberrant activation of B cells in patients with rheumatoid arthritis. Ann N Y Acad Sci 2003; 987: 246-8.
5. Rituximab prescribing information. South San Francisco (CA): Genentech; 2007.
6. Gross JA, Dillon SR, Mudri S, Johnston J, Littau A, Roque R, et al. TACI-Ig neutralizes molecules critical for B cell development and autoimmune disease: impaired B cell maturation in mice lacking BLyS. Immunity 2001; 15: 289-302.
7. Wang H, Marsters SA, Baker T, Chan B, Lee WP, Fu L, et al. TACI-ligand interactions are required for T cell activation and collagen-induced arthritis in mice. Nat Immunol 2001; 2: 632-7.
8. Furie R, Stohl W, Ginzler EM, Becker M, Mishra N, Chatham W, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res Ther 2008; 10: R109.
9. Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 2011; 377: 721-31.
10. Halpern WG, Lappin P, Zanardi T, Cai W, Corcoran M, Zhong J, et al. Chronic administration of belimumab, a BLyS antagonist, decreases tissue and peripheral blood B-lymphocyte populations in cynomolgus monkeys: pharmacokinetic, pharmacodynamic, and toxicologic effects. Toxicol Sci 2006; 91: 586-99.
11. Mckay J, Chwalinska-Sadowska H, Boling E, Valente R, Limanni A, Racewicz A, et al. Belimumab (BmAb), a fully human monoclonal antibody to B-lymphocyte stimulator (BLyS), combined with standard of care therapy reduces the signs and symptoms of rheumatoid arthritis in a heterogenous subject population [abstract]. Arthritis Rheum 2005; 52 Suppl: S710-1.
12. Stohl W, Chatam W, Weisman M, Furie R, Weinstein A, Mishra N, et al. Belimumab (BmAb), a novel fully human monoclonal antibody to B-lymphocyte stimulator (BLyS), selectively modulates B-cell subpopulations and immunoglobulins in a heterogenous rheumatoid arthritis subject population [abstract]. Arthritis Rheum 2005; 52 Suppl: S444.
13. Kikly K, Manetta J, Smith H, Wierda D,. Characterization of LY2127399, a neutralizing antibody for BAFF [abstract]. Arthritis Rheum 2009; 60 Suppl: S693.
14. 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.
15. 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.
16. Van der Heijde DM, van 't Hof MA, van Riel PL, Theunisse LM, Lubberts EW, van Leeuwen MA, et al. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Dis 1990; 49: 916-20.
17. 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.
18. Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum 2011; 63: 573-86.
19. Roche and Biogen Idec decide to suspend Ocrelizumab treatment: rheumatoid arthritis development programme on hold. Hoffman-La Roche Ltd. 3-8-0011.
20. Rigby W, Tony HP, Oelke K, Combe B, Laster A, von Muhlen C, et al. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum 2012; 64: 350-9.
21. Pfizer discontinues Trubion's TRU-015 for rheumatoid arthritis. Pfizer. 6-14-2010.
22. Genovese MC, Kinnman N, de La Bourdonnaye G, Pena Rossi C, Tak PP,. Atacicept in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor antagonist therapy: results of a phase II, randomized, placebo-controlled, dose-finding trial. Arthritis Rheum 2011; 63: 1793-803.
23. Van Vollenhoven RF, Kinnman N, Vincent E, Wax S, Bathon J,. Atacicept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase II, randomized, placebo-controlled trial. Arthritis Rheum 2011; 63: 1782-92.