{"id":1399,"date":"2017-03-24T10:56:16","date_gmt":"2017-03-24T01:56:16","guid":{"rendered":"http:\/\/misterx95.myds.me\/?p=1399"},"modified":"2017-03-24T10:56:16","modified_gmt":"2017-03-24T01:56:16","slug":"journal-club-2017-03-24","status":"publish","type":"post","link":"https:\/\/misterx95.myds.me\/wordpress\/?p=1399","title":{"rendered":"Journal Club, 2017.03.24"},"content":{"rendered":"

10.1056@NEJMoa1606490<\/a><\/p>\n

N Engl J Med.<\/span><\/a> 2017 Mar 2;376(9):826-835. doi: 10.1056\/NEJMoa1606490.<\/div>\n

Anti-Interleukin-31<\/span> Receptor A Antibody for Atopic Dermatitis.<\/h1>\n
Ruzicka T<\/span><\/a>1<\/span><\/sup>, Hanifin JM<\/span><\/a>1<\/span><\/sup>, Furue M<\/span><\/a>1<\/span><\/sup>, Pulka G<\/span><\/a>1<\/span><\/sup>, Mlynarczyk I<\/span><\/a>1<\/span><\/sup>, Wollenberg A<\/span><\/a>1<\/span><\/sup>, Galus R<\/span><\/a>1<\/span><\/sup>, Etoh T<\/span><\/a>1<\/span><\/sup>, Mihara R<\/span><\/a>1<\/span><\/sup>, Yoshida H<\/span><\/a>1<\/span><\/sup>, Stewart J<\/span><\/a>1<\/span><\/sup>, Kabashima K<\/span><\/a>1<\/span><\/sup>; XCIMA Study Group<\/span><\/a>.<\/div>\n
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Author information<\/span><\/span><\/a><\/h3>\n<\/div>\n
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1<\/dt>\n
From the Department of Dermatology and Allergology, Ludwig Maximilian University, Munich, Germany (T.R., A.W.); the Department of Dermatology, Oregon Health and Science University, Portland (J.M.H.); the Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka (M.F.), Tokyo Teishin Hospital (T.E.) and Chugai Pharmaceutical (R.M., H.Y.), Tokyo, the Department of Dermatology, Kyoto University Graduate School of Medicine, Kyoto (K.K.), and Precursory Research for Embryonic Science and Technology, Japan Science and Technology Agency, Saitama (K.K.) – all in Japan; Jagiellonian University School of Medicine, Krakow (G.P.), Academic Health, Dermatology Clinic, Rzeszow (I.M.), and the Department of Histology and Embryology, Center for Biostructure, Medical University of Warsaw, Warsaw (R.G.) – all in Poland; and Chugai Pharma Europe, London (J.S.).<\/dd>\n<\/dl>\n<\/div>\n<\/div>\n
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Abstract<\/h3>\n
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Background Interleukin-31 may play a role in the pathobiologic mechanism of atopic dermatitis and pruritus. We wanted to assess the efficacy and safety of nemolizumab (CIM331), a humanized antibody against interleukin-31 receptor A, in the treatment of atopic dermatitis. Methods In this phase 2, randomized, double-blind, placebo-controlled, 12-week trial, we assigned adults with moderate-to-severe atopic dermatitis that was inadequately controlled by topical treatments to receive subcutaneous nemolizumab (at a dose of 0.1 mg, 0.5 mg, or 2.0 mg per kilogram of body weight) or placebo every 4 weeks or an exploratory dose of 2.0 mg of nemolizumab per kilogram every 8 weeks. The primary end point was the percentage improvement from baseline in the score on the pruritus visual-analogue scale (on which a negative change indicates improvement) at week 12. Secondary end points included changes in the score on the Eczema Area and Severity Index (EASI, on which a negative change indicates improvement), and body-surface area of atopic dermatitis. Results Of 264 patients who underwent randomization, 216 (82%) completed the study. At week 12, among the patients who received nemolizumab every 4 weeks, changes on the pruritus visual-analogue scale were -43.7% in the 0.1-mg group, -59.8% in the 0.5-mg group, and -63.1% in the 2.0-mg group, versus -20.9% in the placebo group (P<0.01 for all comparisons). Changes on the EASI were -23.0%, -42.3%, and -40.9%, respectively, in the nemolizumab groups, versus -26.6% in the placebo group. Respective changes in body-surface area affected by atopic dermatitis were -7.5%, -20.0%, and -19.4% with nemolizumab, versus -15.7% with placebo. Among the patients receiving nemolizumab every 4 weeks, treatment discontinuations occurred in 9 of 53 patients (17%) in the 0.1-mg group, in 9 of 54 (17%) in the 0.5-mg group, and in 7 of 52 (13%) in the 2.0-mg group, versus in 9 of 53 (17%) in the placebo group. Conclusions In this phase 2 trial, nemolizumab at all monthly doses significantly improved pruritus in patients with moderate-to-severe atopic dermatitis, which showed the efficacy of targeting interleukin-31 receptor A. The limited size and length of the trial preclude conclusions regarding adverse events. (Funded by Chugai Pharmaceutical; XCIMA ClinicalTrials.gov number, NCT01986933<\/span><\/a> .).<\/p>\n<\/div>\n<\/div>\n

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10.1056@NEJMoa1606490 N Engl J Med. 2017 Mar 2;376(9):826-835. doi: 10.1056\/NEJMoa1606490. Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis. Ruzicka T1, Hanifin JM1, Furue M1, Pulka G1, Mlynarczyk I1, Wollenberg A1, Galus R1, Etoh T1, Mihara R1, Yoshida H1, Stewart J1, Kabashima K1; XCIMA Study Group. Author information 1 From the Department of Dermatology and Allergology, Ludwig […]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}}},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=\/wp\/v2\/posts\/1399"}],"collection":[{"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1399"}],"version-history":[{"count":1,"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=\/wp\/v2\/posts\/1399\/revisions"}],"predecessor-version":[{"id":1400,"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=\/wp\/v2\/posts\/1399\/revisions\/1400"}],"wp:attachment":[{"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1399"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1399"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/misterx95.myds.me\/wordpress\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1399"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}