{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T03:01:42Z","timestamp":1791255702412,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2008,7,30]],"date-time":"2008-07-30T00:00:00Z","timestamp":1217376000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatism"],"published-print":{"date-parts":[[2008,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the efficacy and safety of rilonacept (Interleukin\u20101 [IL\u20101] Trap), a long\u2010acting and potent inhibitor of IL\u20101, in patients with cryopyrin\u2010associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle\u2010Wells syndrome (MWS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Forty\u2010seven adult patients with CAPS, as defined by mutations in the causative <jats:italic>NLRP3<\/jats:italic> (<jats:italic>CIAS1<\/jats:italic>) gene and pathognomonic symptoms, were enrolled in 2 consecutive phase III studies. Study 1 involved a 6\u2010week randomized double\u2010blind comparison of weekly subcutaneous injections of rilonacept (160 mg) versus placebo. Study 2 consisted of 9 weeks of single\u2010blind treatment with rilonacept (part A), followed by a 9\u2010week, randomized, double\u2010blind, placebo\u2010controlled withdrawal procedure (part B). Primary efficacy was evaluated using a validated composite key symptom score.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Forty\u2010four patients completed both studies. In study 1, rilonacept therapy reduced the group mean composite symptom score by 84%, compared with 13% with placebo therapy (primary end point; <jats:italic>P<\/jats:italic> &lt; 0.0001 versus placebo). Rilonacept also significantly improved all other efficacy end points in study 1 (numbers of multisymptom and single\u2010symptom disease flare days, single\u2010symptom scores, physician's and patient's global assessments of disease activity, limitations in daily activities, and C\u2010reactive protein and serum amyloid A [SAA] levels). In study 2 part B, rilonacept was superior to placebo for maintaining the improvements seen with rilonacept therapy, as shown by all efficacy parameters (primary end point; <jats:italic>P<\/jats:italic> &lt; 0.0001 versus placebo). Rilonacept was generally well tolerated; the most common adverse events were injection site reactions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Treatment with weekly rilonacept provided marked and lasting improvement in the clinical signs and symptoms of CAPS, and normalized the levels of SAA from those associated with risk of developing amyloidosis. Rilonacept exhibited a generally favorable safety and tolerability profile.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.23687","type":"journal-article","created":{"date-parts":[[2008,8,2]],"date-time":"2008-08-02T05:17:08Z","timestamp":1217654228000},"page":"2443-2452","source":"Crossref","is-referenced-by-count":511,"title":["Efficacy and safety of rilonacept (interleukin\u20101 trap) in patients with cryopyrin\u2010associated periodic syndromes: Results from two sequential placebo\u2010controlled studies"],"prefix":"10.1002","volume":"58","author":[{"given":"Hal M.","family":"Hoffman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin L.","family":"Throne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N. 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