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Efficacy and safety of tabalumab, an anti-B-cell-activating 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
  1. Josef S Smolen1,
  2. Michael E Weinblatt2,
  3. Désirée van der Heijde3,
  4. William F C Rigby4,
  5. Ronald van Vollenhoven5,
  6. Clifton O Bingham III6,
  7. Melissa Veenhuizen7,
  8. Anne Gill7,
  9. Fangyi Zhao7,
  10. Wendy J Komocsar7,
  11. Pierre-Yves Berclaz7,
  12. Robert Ortmann7,
  13. Chin Lee7
  1. 1Division of Rheumatology, Department of Medicine 3, Medical University of Vienna and Hietzing Hospital, Vienna, Austria
  2. 2Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA
  3. 3Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  4. 4The Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA
  5. 5Department of Medicine, Karolinska Institute, Stockholm, Sweden
  6. 6Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA
  7. 7Eli Lilly and Company, Indianapolis, Indiana, USA
  1. Correspondence to Chin Lee, Eli Lilly and Company, Lilly Corporate Center (Drop Code 1534), Indianapolis, IN 46285, USA; leechinhyok{at}


Objectives Randomised, double-blind, placebo-controlled study to evaluate efficacy and safety of tabalumab in patients with rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX-IR).

Methods 1041 patients with moderate–severe RA despite ongoing MTX enrolled in a 52-week study evaluating subcutaneous tabalumab 120 mg every four weeks (120/Q4W) or 90 mg every two weeks (90/Q2W) versus placebo. Primary endpoints were American College of Rheumatology 20% (ACR20) response rate and Health Assessment Questionnaire-Disability Index change from baseline at 24 weeks and modified Total Sharp Score (mTSS) change at 52 weeks.

Results There were no significant differences in ACR20 responses at week 24 or mTSS change from baseline at week 52 among treatment groups. Declines were seen in CD20+ B cells and immunoglobulin levels in tabalumab groups, but not placebo: B cells (−15.0%, −18.8%, 5.3%, in the 120/Q4W, 90/Q2W, and placebo groups, respectively); IgM (−16.3%, −19.4%, −0.1%), IgA (−11.4%, −4.7%, 1.2%) and IgG (−8.6%, −7.8%, 0.1%). Discontinuations due to adverse events were similar between groups. Numerically more serious infections were reported in tabalumab groups (1.7%, 0.6%, 0.3%); numerically more injection-site reactions were reported in the 90/Q2W group (2.3%, 4.3%, 2.3%).

Conclusions Neither clinical efficacy nor significant safety signals were observed with tabalumab despite evidence of biological activity. This study was terminated early due to insufficient efficacy.

Trial registration number NCT01198002.

  • B cells
  • Autoimmune Diseases
  • Rheumatoid Arthritis

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