{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T11:07:31Z","timestamp":1781953651934,"version":"3.54.5"},"reference-count":26,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2015,6,18]]},"published-print":{"date-parts":[[2015,8]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Tabalumab is a human monoclonal antibody that neutralises B-cell activating factor.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To evaluate tabalumab efficacy and safety in patients with rheumatoid arthritis (RA).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This phase 3, randomised, double-blind, placebo-controlled study evaluated 456 patients with active RA after 24-week treatment with subcutaneous tabalumab (120\u2005mg every 4\u2005weeks (120\/Q4W) or 90\u2005mg every 2\u2005weeks (90\/Q2W)) versus placebo, with loading doses (240 or 180\u2005mg) at week 0. Patients were allowed background disease-modifying antirheumatic drugs and previously discontinued \u22651 tumour necrosis factor \u03b1 inhibitors for lack of efficacy\/intolerance. Primary end point was American College of Rheumatology 20% (ACR20) response at 24\u2005weeks. This study was terminated early due to futility.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Most patients had moderate-to-high baseline disease activity. There was no significant difference in week 24 ACR20 responses between 120\/Q4W, 90\/Q2W, and placebo (17.6%, 24.3%, 20%) per non-responder imputation analysis. Mean percent changes in CD20+ B-cell count (\u221210.8%, \u22129.6%, +10.9%) demonstrated expected pharmacodynamic effects. Treatment-emergent adverse events (AEs) were similar (59.5%, 51.7%, 52.6%), as were AE discontinuations (2.6%, 2.7%, 2.6%), serious AEs (4.6%, 4.1%, 3.9%), serious infectious events (1.3%, 0, 0) and events of interest: infections (23.5%, 25.9%, 24%), injection site reactions (13.1%, 25.8%, 11%) and allergy\/hypersensitivity (3.9%, 4.1%, 3.9%) reports. Incidence of treatment-emergent antidrug antibodies was similar to placebo (3.9%, 4.8%, 3.9%). No deaths or new\/unexpected safety findings were reported.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Tabalumab did not demonstrate clinical efficacy in patients with RA in this phase 3 study, despite evidence of biological activity. There were no notable differences in safety parameters between tabalumab treatment groups and placebo.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number:<\/jats:title>\n                  <jats:p>NCT01202773.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2014-000037","type":"journal-article","created":{"date-parts":[[2015,8,12]],"date-time":"2015-08-12T21:19:34Z","timestamp":1439414374000},"page":"e000037","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":17,"title":["Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study"],"prefix":"10.1136","volume":"1","clinical-trial-number":[{"clinical-trial-number":"nct01202773","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01198002","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Michael","family":"Schiff","sequence":"first","affiliation":[{"name":"Rheumatology Division, School of Medicine, University of Colorado, Denver, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Combe","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Lapeyronie Hospital, Montpellier 1 University, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"D\u00f6rner","sequence":"additional","affiliation":[{"name":"Department of Medicine\/Rheumatology and Clinical Immunology, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel M","family":"Kremer","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Albany Medical College, Albany, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas W","family":"Huizinga","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Veenhuizen","sequence":"additional","affiliation":[{"name":"Global Patient Safety Medical and Benefit-Risk Management, Lilly and Company, Indianapolis, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Gill","sequence":"additional","affiliation":[{"name":"Autoimmune Medical, Bio-Medicines Business Unit, Lilly and Company, Indianapolis, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Komocsar","sequence":"additional","affiliation":[{"name":"Autoimmune Medical, Bio-Medicines 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