Efficacy and safety of tabalumab, an anti-B-cellactivating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: Results from a phase III multicentre, randomised, double-blind study

Annals of the Rheumatic Diseases

Volumn 74, Issue 8, 2015, Pages 1567-1570

  Smolen, Josef S ^a   Weinblatt, Michael E ^b   Van Der Heijde, Désirée ^c   Rigby, William F C ^d   Vollenhoven, Ronald Van ^e   Bingham, Clifton O ^f   Veenhuizen, Melissa ^g   Gill, Anne ^g   Zhao, Fangyi ^g   Komocsar, Wendy J ^g   Berclaz, Pierre Yves ^g   Ortmann, Robert ^g   Lee, Chin ^g  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^d DARTMOUTH MEDICAL SCHOOL   (United States)

^e KAROLINSKA INSTITUTE   (Sweden)

^f JOHNS HOPKINS UNIVERSITY   (United States)

^g ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

B CELL ACTIVATING FACTOR; C REACTIVE PROTEIN; CD20 ANTIGEN; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; METHOTREXATE; PLACEBO; TABALUMAB; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ADULT; ARTICLE; B LYMPHOCYTE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DISEASE COURSE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TREATMENT FAILURE; HEART INFARCTION; HUMAN; INJECTION SITE REACTION; INTENTION TO TREAT ANALYSIS; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; SEPSIS; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; EARLY TERMINATION OF CLINICAL TRIAL; TREATMENT FAILURE;

ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; B-CELL ACTIVATING FACTOR; DOUBLE-BLIND METHOD; EARLY TERMINATION OF CLINICAL TRIALS; HUMANS; INTENTION TO TREAT ANALYSIS; METHOTREXATE; TREATMENT FAILURE;

EID: 84940369298     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2014-207090     Document Type: Article

References (9)

1. Stohl W, Merrill JT, McKay JD, et al. Efficacy and safety of belimumab in patients with rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled, dose-ranging Study. J Rheumatol 2013;40:579-89.
2. van Vollenhoven RF, Kinnman N, Vincent E, et al. 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.
3. Genovese MC, Kinnman N, de La bourdonnaye G, et al. 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.
4. Manetta J, Bina H, Ryan P, et al. Generation and characterization of tabalumab, a human monoclonal antibody that neutralizes both soluble and membrane-bound B-cell activating factor. J Inflamm Res 2014;7:121-31.
5. Genovese MC, Lee E, Satterwhite J, et al. A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 2013;72:1453-60.
6. Genovese MC, Bojin S, Biagini IM, et al. Tabalumab in rheumatoid arthritis patients with an inadequate response to methotrexate and naive to biologic therapy: a phase II, randomized, placebo-controlled trial. Arthritis Rheum 2013;65:880-9.
7. Van der Heijde D. How to read radiographs according to the Sharp/van der Heijde method. J Rheumatol 1999;26:743-5.
8. Greenwald M, Szczepanski L, Kennedy A, et al. A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell activating factor monoclonal antibody, for rheumatoid arthritis. Arthritis Res Ther 2014;16:415-24.
9. Silverman GJ, Pelzek A. Rheumatoid arthritis clinical benefits from abatacept, cytokine blockers, and rituximab are all linked to modulation of memory B cell responses. J Rheumatol 2014;41:825-8.