{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T17:42:45Z","timestamp":1790185365231,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2014,10,24]],"date-time":"2014-10-24T00:00:00Z","timestamp":1414108800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"funder":[{"DOI":"10.13039\/100004328","name":"Genentech","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis Care &amp;amp; Research"],"published-print":{"date-parts":[[2014,11]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>The efficacy and safety of subcutaneous tocilizumab (TCZ\u2010SC) versus subcutaneous placebo (PBO\u2010SC) was evaluated in patients with rheumatoid arthritis who had an inadequate response to disease\u2010modifying antirheumatic drugs in the BREVACTA study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients (n = 656) were randomized 2:1 to receive TCZ\u2010SC 162 mg every other week or PBO\u2010SC every other week for 24 weeks; 20% previously received anti\u2013tumor necrosis factor treatment. Escape therapy with TCZ\u2010SC 162 mg weekly was offered from week 12 for inadequate response. The primary end point was the American College of Rheumatology 20% improvement (ACR20) response at week 24. The key secondary outcomes were radiographic progression and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>TCZ\u2010SC was superior to PBO\u2010SC for ACR20 response at week 24 (60.9% versus 31.5%; <jats:italic>P<\/jats:italic> &lt; 0.0001). All secondary end points showed TCZ\u2010SC to be superior to PBO\u2010SC, including ACR50 and ACR70 response (40% and 20% for TCZ\u2010SC, respectively, and 12% and 5% for PBO\u2010SC, respectively; <jats:italic>P<\/jats:italic> &lt; 0.0001 for both) and Disease Activity Score in 28 joints (DAS28) remission (DAS28 &lt;2.6; 32% versus 4% [<jats:italic>P<\/jats:italic> &lt; 0.0001]). The mean change in modified Sharp\/van der Heijde score was significantly lower in the TCZ\u2010SC group than the PBO\u2010SC group (0.62 versus 1.23; <jats:italic>P<\/jats:italic> = 0.0149). Adverse events (AEs) and serious AEs (SAEs) were comparable between the TCZ\u2010SC and PBO\u2010SC groups; 4.6% and 3.7% of patients had at least 1 SAE, respectively, and infection was the most common SAE in 2.1% and 1.8% of patients, respectively. More injection site reactions occurred with TCZ\u2010SC than PBO\u2010SC (7.1% versus 4.1%). No anaphylaxis or serious hypersensitivity reactions occurred. There were 3 deaths in the TCZ\u2010SC group and 0 in the PBO\u2010SC group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>TCZ\u2010SC every other week had significantly greater efficacy, including ACR end points and inhibition of joint damage, compared with PBO\u2010SC. TCZ\u2010SC was well tolerated and its safety profile was comparable with that of previous intravenous TCZ studies.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr.22384","type":"journal-article","created":{"date-parts":[[2014,6,18]],"date-time":"2014-06-18T14:11:07Z","timestamp":1403100667000},"page":"1653-1661","source":"Crossref","is-referenced-by-count":131,"title":["Subcutaneous Tocilizumab Versus Placebo in Combination With Disease\u2010Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis"],"prefix":"10.1002","volume":"66","author":[{"given":"Alan","family":"Kivitz","sequence":"first","affiliation":[{"name":"Altoona Center for Clinical Research Duncansville Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ewa","family":"Olech","sequence":"additional","affiliation":[{"name":"University of Nevada School of Medicine Las 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