{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T20:19:10Z","timestamp":1789935550150,"version":"4.0.1"},"reference-count":35,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2015,5,25]],"date-time":"2015-05-25T00:00:00Z","timestamp":1432512000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Novo Nordisk A\/S, Denmark","award":["NCT01282255"],"award-info":[{"award-number":["NCT01282255"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis & Rheumatology"],"published-print":{"date-parts":[[2015,6]]},"abstract":"Objective<\/jats:title>Interleukin\u201020 (IL\u201020) is implicated in the pathogenesis of rheumatoid arthritis (RA). The efficacy, safety, and tolerability of NNC0109\u20100012, a selective anti\u2013IL\u201020 recombinant human monoclonal antibody (mAb), were assessed in patients with active RA who had an inadequate response to methotrexate therapy.<\/jats:p><\/jats:sec>Methods<\/jats:title>Sixty\u2010seven patients with RA were enrolled and randomized (2:1) to receive NNC0109\u20100012 (3 mg\/kg per week, subcutaneously) or placebo in a phase IIa, double\u2010blind, 12\u2010week trial with a 13\u2010week followup. The primary end point was change in the Disease Activity Score in 28 joints based on C\u2010reactive protein level (DAS28\u2010CRP) from baseline to week 12.<\/jats:p><\/jats:sec>Results<\/jats:title>In patients treated with NNC0109\u20100012, the primary end point, improvement in the DAS28\u2010CRP at week 12, was achieved (estimated difference \u22120.88; P<\/jats:italic>\u2009=\u20090.02), with significant improvement starting at week 1. A greater response was observed in seropositive patients (estimated difference \u22121.66; P<\/jats:italic>\u2009<\u20090.001), which was sustained through 13 weeks of followup, whereas no improvement was noted in patients with seronegative RA. A significant proportion of patients with seropositive RA receiving NNC0109\u20100012, compared to those receiving placebo, achieved treatment responses according to the American College of Rheumatology 20% (ACR20) (59% versus 21%), ACR50 (48% versus 14%), and ACR70 (35% versus 0%) levels of improvement, and showed greater improvements in the Health Assessment Questionnaire disability index (P<\/jats:italic>\u2009=\u20090.047). The most frequent adverse events reported with NNC0109\u20100012 were injection site reactions and infections (e.g., herpes, nasopharyngitis, respiratory, and urinary). No serious infections or discontinuations associated with NNC0109\u20100012 were observed.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>In this phase IIa trial, treatment with NNC0109\u20100012 (anti\u2013IL\u201020 mAb) was effective in patients with seropositive RA as early as week 1, with further improvements to week 12. No safety or tolerability concerns were identified with weekly NNC0109\u20100012 administration.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.39083","type":"journal-article","created":{"date-parts":[[2015,2,23]],"date-time":"2015-02-23T11:19:49Z","timestamp":1424690389000},"page":"1438-1448","source":"Crossref","is-referenced-by-count":39,"title":["Efficacy and Safety of Anti\u2013Interleukin\u201020 Monoclonal Antibody in Patients With Rheumatoid Arthritis: A Randomized Phase IIa Trial"],"prefix":"10.1002","volume":"67","author":[{"given":"Ladislav","family":"\u0160enolt","sequence":"first","affiliation":[{"name":"Institute of Rheumatology and 1st Faculty of Medicine, Charles University in Prague Prague Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Leszczynski","sequence":"additional","affiliation":[{"name":"Poznan University of Medical Sciences Poznan Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Dokoupilov\u00e1","sequence":"additional","affiliation":[{"name":"Medical Plus, s.r.o. 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