{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T02:01:37Z","timestamp":1790906497751,"version":"4.1.0"},"reference-count":24,"publisher":"Becaris Publishing Limited","issue":"14","funder":[{"DOI":"10.13039\/100013223","name":"PTC Therapeutics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013223","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:p>\n            <jats:bold>Aim:<\/jats:bold>\n            Assess the totality of efficacy evidence for ataluren in\u00a0patients with\u00a0nonsense mutation Duchenne muscular dystrophy (nmDMD).\n            <jats:bold>Materials &amp; methods:<\/jats:bold>\n            Data from the two completed randomized controlled trials (ClinicalTrials.gov: NCT00592553; NCT01826487) of ataluren in nmDMD were combined to examine the intent-to-treat (ITT) populations and two patient subgroups (baseline 6-min walk distance [6MWD] \u2265300\u2013&lt;400 or &lt;400\u00a0m). Meta-analyses examined 6MWD change from baseline to week 48.\n            <jats:bold>Results:<\/jats:bold>\n            Statistically significant differences in 6MWD change with ataluren versus placebo were observed across all three meta-analyses. Least-squares mean difference (95% CI): ITT (n\u00a0=\u00a0342), +17.2 (0.2\u201334.1) m, p\u00a0=\u00a00.0473; \u2265300\u2013&lt;400\u00a0m (n\u00a0=\u00a0143), +43.9 (18.2\u201369.6) m, p\u00a0=\u00a00.0008; &lt;400\u00a0m (n\u00a0=\u00a0216), +27.7 (6.4\u201349.0) m, p\u00a0=\u00a00.0109.\n            <jats:bold>Conclusion:<\/jats:bold>\n            These meta-analyses support previous evidence for ataluren in slowing disease progression versus placebo in patients with nmDMD\u00a0over 48\u00a0weeks. Treatment benefit was most evident in patients with a baseline 6MWD \u2265300\u2013&lt;400\u00a0m (the ambulatory transition phase), thereby informing future trial design.\n          <\/jats:p>","DOI":"10.2217\/cer-2020-0095","type":"journal-article","created":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T11:29:56Z","timestamp":1598527796000},"page":"973-984","source":"Crossref","is-referenced-by-count":49,"title":["Meta-analyses of ataluren randomized controlled trials in nonsense mutation Duchenne muscular dystrophy"],"prefix":"10.57264","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5216-7564","authenticated-orcid":false,"given":"Craig","family":"Campbell","sequence":"first","affiliation":[{"name":"Schulich School of Medicine &amp; Dentistry, Western University, London, ON, N6A 5C1, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard J","family":"Barohn","sequence":"additional","affiliation":[{"name":"University of Kansas Medical Center, Kansas City, KS\u00a066160, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Bertini","sequence":"additional","affiliation":[{"name":"Bambino Ges\u00f9 Children\u2019s Research Hospital, Rome, 00146, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brigitte","family":"Chabrol","sequence":"additional","affiliation":[{"name":"H\u00f4pital de la Timone, Unit\u00e9 de M\u00e9decine Infantile, Marseille, 13385, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giacomo Pietro","family":"Comi","sequence":"additional","affiliation":[{"name":"IRCCS Fondazione Ca'Granda Ospedale Maggiore Policlinico, Dino Ferrari Centre, Department of Pathophysiology &amp; Transplantation, University of Milan, Milan, 20122, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Basil T","family":"Darras","sequence":"additional","affiliation":[{"name":"Boston Children\u2019s Hospital, Harvard Medical School, Boston, MA 02115, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard S","family":"Finkel","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital of Philadelphia, Philadelphia, PA 19104, USA"},{"name":"St. Jude Children\u2019s Research Hospital, Memphis, TN 38105, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin M","family":"Flanigan","sequence":"additional","affiliation":[{"name":"Nationwide Children\u2019s Hospital, Columbus, OH 43205, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Goemans","sequence":"additional","affiliation":[{"name":"University Hospitals Leuven, KU Leuven, Leuven, 3000, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan T","family":"Iannaccone","sequence":"additional","affiliation":[{"name":"University of Texas Southwestern Medical Center, Dallas, TX 75390, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristi J","family":"Jones","sequence":"additional","affiliation":[{"name":"Kids Neuroscience, The Children\u2019s Hospital at Westmead, Westmead, NSW, 2145, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janbernd","family":"Kirschner","sequence":"additional","affiliation":[{"name":"Department of Neuropediatrics &amp; Muscle Disorders, Medical Center, University of Freiburg, Freiburg\u00a079110, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean K","family":"Mah","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Pediatric Neurology, Alberta Children\u2019s Hospital, University of Calgary, Calgary, AB\u00a0T3B 6A8, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine D","family":"Mathews","sequence":"additional","affiliation":[{"name":"Departments of Pediatrics &amp; Neurology, Division of Pediatric Neurology, University of Iowa Carver College of Medicine, Iowa City, IA 52242, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Craig M","family":"McDonald","sequence":"additional","affiliation":[{"name":"University of California Davis Health, Sacramento, CA 95817, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eugenio","family":"Mercuri","sequence":"additional","affiliation":[{"name":"Department of Pediatric Neurology, Catholic University, Rome, 00168, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoram","family":"Nevo","sequence":"additional","affiliation":[{"name":"Schneider Children\u2019s Medical Center, Tel Aviv University, Tel Aviv, 6997801, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yann","family":"P\u00e9r\u00e9on","sequence":"additional","affiliation":[{"name":"Reference Centre for Neuromuscular Disorders AOC, H\u00f4tel-Dieu, Nantes, 44000, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J Ben","family":"Renfroe","sequence":"additional","affiliation":[{"name":"Child Neurology Center of Northwest Florida, Gulf Breeze, FL 32561, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monique M","family":"Ryan","sequence":"additional","affiliation":[{"name":"The Royal Children\u2019s Hospital, Parkville, Victoria, 3052, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacinda B","family":"Sampson","sequence":"additional","affiliation":[{"name":"Stanford University Medical Center, Department of Neurology &amp; 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