{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T02:20:32Z","timestamp":1783650032231,"version":"3.55.0"},"reference-count":45,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2018,3,31]],"date-time":"2018-03-31T00:00:00Z","timestamp":1522454400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004628","name":"MedImmune","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004628","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis & Rheumatology"],"published-print":{"date-parts":[[2018,5]]},"abstract":"\n Objective<\/jats:title>\n \n Mavrilimumab, a human monoclonal antibody, targets granulocyte\u2013macrophage colony\u2010stimulating factor receptor \u03b1. We undertook to determine the long\u2010term safety and efficacy of mavrilimumab in rheumatoid arthritis patients in 2 phase\n II<\/jats:styled-content>\n b studies (1071 and 1107) and in 1 open\u2010label extension study (ClinicalTrials.gov identifier:\n NCT<\/jats:styled-content>\n 01712399).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n In study 1071, patients with an inadequate response to disease\u2010modifying antirheumatic drugs (\n DMARD<\/jats:styled-content>\n s) received mavrilimumab (30, 100, or 150 mg) or placebo every other week plus methotrexate. In study 1107, patients with an inadequate response to anti\u2013tumor necrosis factor agents and\/or\n DMARD<\/jats:styled-content>\n s received 100 mg mavrilimumab every other week or 50 mg golimumab every 4 weeks plus methotrexate. Patients entering the open\u2010label extension study received 100 mg mavrilimumab every other week plus methotrexate. Long\u2010term safety and efficacy of mavrilimumab were assessed.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 442 patients received mavrilimumab (14 of 245 patients from study 1071, 9 of 70 patients from study 1107, and 52 of 397 patients from the open\u2010label extension study discontinued mavrilimumab treatment throughout the studies). The cumulative safety exposure was 899 patient\u2010years; the median duration of mavrilimumab treatment was 2.5 years (range 0.1\u20133.3 years). The most common treatment\u2010emergent adverse events (\n AE<\/jats:styled-content>\n s) were nasopharyngitis (n = 69; 7.68 per 100 patient\u2010years) and bronchitis (n = 51; 5.68 per 100 patient\u2010years). At weeks 74 and 104, 3.5% and 6.2% of patients, respectively, demonstrated reduction in forced expiratory volume in 1 second, while 2.9% and 3.4% of patients, respectively, demonstrated reduction in forced vital capacity (>20% reduction from baseline to <80% predicted). Most pulmonary changes were transient and only infrequently associated with\n AE<\/jats:styled-content>\n s. Mavrilimumab at 100 mg every other week demonstrated sustained efficacy; at week 122, 65.0% of patients achieved a Disease Activity Score in 28 joints using the C\u2010reactive protein level (\n DAS<\/jats:styled-content>\n 28\u2010\n CRP<\/jats:styled-content>\n ) of <3.2, and 40.6% of patients achieved a\n DAS<\/jats:styled-content>\n 28\u2010\n CRP<\/jats:styled-content>\n of <2.6.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Long\u2010term treatment with mavrilimumab maintained response and was well\u2010tolerated with no increased incidence of treatment\u2010emergent\n AE<\/jats:styled-content>\n s. Safety data were comparable with those from both phase\n II<\/jats:styled-content>\n b qualifying studies.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.40420","type":"journal-article","created":{"date-parts":[[2018,1,23]],"date-time":"2018-01-23T12:42:43Z","timestamp":1516711363000},"page":"679-689","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":73,"title":["Mavrilimumab, a Fully Human Granulocyte\u2013Macrophage Colony\u2010Stimulating Factor Receptor \u03b1 Monoclonal Antibody"],"prefix":"10.1002","volume":"70","author":[{"given":"Gerd R.","family":"Burmester","sequence":"first","affiliation":[{"name":"Charit\u00e9 \u2013 University Medicine Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iain B.","family":"McInnes","sequence":"additional","affiliation":[{"name":"University of Glasgow Glasgow UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel M.","family":"Kremer","sequence":"additional","affiliation":[{"name":"The Albany Medical College Albany New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"Miranda","sequence":"additional","affiliation":[{"name":"Centro de Estudios Reumatol\u00f3gicos Santiago Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji\u0159\u00ed","family":"Vencovsk\u00fd","sequence":"additional","affiliation":[{"name":"Institute of Rheumatology Prague Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Godwood","sequence":"additional","affiliation":[{"name":"MedImmune Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marius","family":"Albulescu","sequence":"additional","affiliation":[{"name":"MedImmune Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Alex","family":"Michaels","sequence":"additional","affiliation":[{"name":"MedImmune Gaithersburg Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiang","family":"Guo","sequence":"additional","affiliation":[{"name":"MedImmune Gaithersburg Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Close","sequence":"additional","affiliation":[{"name":"MedImmune Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Weinblatt","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital Boston 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