{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T16:12:54Z","timestamp":1791216774981,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2004,6,3]],"date-time":"2004-06-03T00:00:00Z","timestamp":1086220800000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatism"],"published-print":{"date-parts":[[2004,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine in a placebo\u2010controlled, double\u2010blind trial the safety profile of daily anakinra (Kineret) use in patients with active rheumatoid arthritis (RA) and concurrent comorbid conditions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In 169 centers in 9 countries, 1,414 patients with active RA were randomly assigned to receive either anakinra (100 mg) or placebo treatment (4:1 anakinra\u2010to\u2010placebo allocation ratio), with study drug administered by daily subcutaneous injection for 6 months. The current post hoc analysis assessed baseline comorbid conditions, and patients were considered at high risk for the occurrence of adverse events if they had a history of at least one of the following: cardiovascular event, pulmonary event, central nervous system\u2013related event, infection, diabetes, malignancy, or renal impairment. Within each treatment group (anakinra or placebo), incidence rates were summarized for serious adverse events, infectious events, and serious infectious events in high\u2010risk patients and compared with these incidence rates in patients without comorbid conditions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The majority of patients in the trial had one or more comorbid conditions. In these high\u2010risk patients, there were no differences in the incidence of serious adverse events or infectious events between treatment groups. The incidence of serious infectious events with anakinra use was similar between high\u2010risk patients (2.5%) and the entire study population (2.1%) and was not attributable to any single comorbidity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Results of the analysis of adverse events in patients with active RA and coexisting comorbidities suggest that the favorable safety profile of anakinra is maintained in a high\u2010risk patient population.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.20277","type":"journal-article","created":{"date-parts":[[2004,6,3]],"date-time":"2004-06-03T17:01:31Z","timestamp":1086282091000},"page":"1752-1760","source":"Crossref","is-referenced-by-count":72,"title":["The safety of anakinra in high\u2010risk patients with active rheumatoid arthritis: Six\u2010month observations of patients with comorbid conditions"],"prefix":"10.1002","volume":"50","author":[{"given":"Michael H.","family":"Schiff","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gino","family":"DiVittorio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Tesser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roy","family":"Fleischmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joy","family":"Schechtman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanford","family":"Hartman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan M.","family":"Solinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2004,6,3]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199005033221805"},{"key":"e_1_2_6_3_2","volume-title":"Rheumatoid arthritis, etiology, diagnosis and treatment","author":"Utsinger PD","year":"1985"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780330302"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/0090-1229(90)90126-B"},{"key":"e_1_2_6_6_2","first-page":"225","article-title":"Arthritis induced by continuous infusion of hr\u2010interleukin\u20101\u03b1 into the rabbit knee\u2010joint","volume":"11","author":"Feige U","year":"1989","journal-title":"Int J Tissue React"},{"key":"e_1_2_6_7_2","doi-asserted-by":"crossref","first-page":"834","DOI":"10.4049\/jimmunol.141.3.834","article-title":"In vivo administration with IL\u20101 accelerates the development of collagen\u2010induced arthritis in mice","volume":"141","author":"Hom JT","year":"1988","journal-title":"J Immunol"},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/0090-1229(90)90072-X"},{"key":"e_1_2_6_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(88)90185-7"},{"key":"e_1_2_6_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF00270301"},{"key":"e_1_2_6_11_2","first-page":"295","article-title":"Cytokines and the chronic inflammation of rheumatic disease. 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