Phase 2a Study of Ataluren-Mediated Dystrophin Production in Patients with Nonsense Mutation Duchenne Muscular Dystrophy
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{"title"=>"Phase 2a study of ataluren-mediated dystrophin production in patients with nonsense mutation Duchenne muscular dystrophy", "type"=>"journal", "authors"=>[{"first_name"=>"Richard S.", "last_name"=>"Finkel", "scopus_author_id"=>"7006041140"}, {"first_name"=>"Kevin M.", "last_name"=>"Flanigan", "scopus_author_id"=>"7004104854"}, {"first_name"=>"Brenda", "last_name"=>"Wong", "scopus_author_id"=>"8697504500"}, {"first_name"=>"Carsten", "last_name"=>"Bönnemann", "scopus_author_id"=>"7003763204"}, {"first_name"=>"Jacinda", "last_name"=>"Sampson", "scopus_author_id"=>"7102092475"}, {"first_name"=>"H. Lee", "last_name"=>"Sweeney", "scopus_author_id"=>"7004380963"}, {"first_name"=>"Allen", "last_name"=>"Reha", "scopus_author_id"=>"36022998700"}, {"first_name"=>"Valerie J.", "last_name"=>"Northcutt", "scopus_author_id"=>"16064517500"}, {"first_name"=>"Gary", "last_name"=>"Elfring", "scopus_author_id"=>"6701810426"}, {"first_name"=>"Jay", "last_name"=>"Barth", "scopus_author_id"=>"56750780000"}, {"first_name"=>"Stuart W.", "last_name"=>"Peltz", "scopus_author_id"=>"7006002597"}], "year"=>2013, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"24349052", "scopus"=>"2-s2.0-84892581676", "doi"=>"10.1371/journal.pone.0081302", "sgr"=>"84892581676", "pui"=>"372133982"}, "id"=>"aa13dc8f-a908-3440-b6f4-f4dc14a78b7b", "abstract"=>"BACKGROUND: Approximately 13% of boys with Duchenne muscular dystrophy (DMD) have a nonsense mutation in the dystrophin gene, resulting in a premature stop codon in the corresponding mRNA and failure to generate a functional protein. Ataluren (PTC124) enables ribosomal readthrough of premature stop codons, leading to production of full-length, functional proteins.\\n\\nMETHODS: This Phase 2a open-label, sequential dose-ranging trial recruited 38 boys with nonsense mutation DMD. The first cohort (n = 6) received ataluren three times per day at morning, midday, and evening doses of 4, 4, and 8 mg/kg; the second cohort (n = 20) was dosed at 10, 10, 20 mg/kg; and the third cohort (n = 12) was dosed at 20, 20, 40 mg/kg. Treatment duration was 28 days. Change in full-length dystrophin expression, as assessed by immunostaining in pre- and post-treatment muscle biopsy specimens, was the primary endpoint.\\n\\nFINDINGS: Twenty three of 38 (61%) subjects demonstrated increases in post-treatment dystrophin expression in a quantitative analysis assessing the ratio of dystrophin/spectrin. A qualitative analysis also showed positive changes in dystrophin expression. Expression was not associated with nonsense mutation type or exon location. Ataluren trough plasma concentrations active in the mdx mouse model were consistently achieved at the mid- and high- dose levels in participants. Ataluren was generally well tolerated.\\n\\nINTERPRETATION: Ataluren showed activity and safety in this short-term study, supporting evaluation of ataluren 10, 10, 20 mg/kg and 20, 20, 40 mg/kg in a Phase 2b, double-blind, long-term study in nonsense mutation DMD.\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00264888.", "link"=>"http://www.mendeley.com/research/phase-2a-study-atalurenmediated-dystrophin-production-patients-nonsense-mutation-duchenne-muscular-d", "reader_count"=>106, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>1, "Librarian"=>2, "Researcher"=>18, "Student > Doctoral Student"=>7, "Student > Ph. D. Student"=>20, "Student > Postgraduate"=>8, "Student > Master"=>22, "Other"=>8, "Student > Bachelor"=>15, "Professor"=>3}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>1, "Librarian"=>2, "Researcher"=>18, "Student > Doctoral Student"=>7, "Student > Ph. D. Student"=>20, "Student > Postgraduate"=>8, "Student > Master"=>22, "Other"=>8, "Student > Bachelor"=>15, "Professor"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Agricultural and Biological Sciences"=>44, "Business, Management and Accounting"=>1, "Veterinary Science and Veterinary Medicine"=>1, "Chemistry"=>4, "Computer Science"=>1, "Engineering"=>1, "Biochemistry, Genetics and Molecular Biology"=>13, "Medicine and Dentistry"=>30, "Neuroscience"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>3, "Sports and Recreations"=>1, "Psychology"=>1, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>30}, "Sports and Recreations"=>{"Sports and Recreations"=>1}, "Psychology"=>{"Psychology"=>1}, "Unspecified"=>{"Unspecified"=>4}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>3}, "Engineering"=>{"Engineering"=>1}, "Chemistry"=>{"Chemistry"=>4}, "Neuroscience"=>{"Neuroscience"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>44}, "Computer Science"=>{"Computer Science"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>13}, "Veterinary Science and Veterinary Medicine"=>{"Veterinary Science and Veterinary Medicine"=>1}}, "reader_count_by_country"=>{"Netherlands"=>1, "United States"=>1, "Japan"=>1, "Taiwan"=>1, "France"=>1}, "group_count"=>7}

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  • {"files"=>["https://ndownloader.figshare.com/files/1310846"], "description"=>"<p>CONSORT Flow Diagram.</p>", "links"=>[], "tags"=>[], "article_id"=>874445, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0081302.g001", "stats"=>{"downloads"=>0, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CONSORT_Flow_Diagram_/874445", "title"=>"CONSORT Flow Diagram.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-12-11 03:00:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/1310865"], "description"=>"a<p>Qualitative: Response = ≥2/3 blinded reviewers observed more dystrophin in post-treatment image compared to pre-treatment image. Quantitative: Change in dystrophin:spectrin ratio from pre-treatment to post-treatment.</p>b<p>Fold change at 10 µg/mL over 0 µg/mL.</p>c<p>Biopsies lost during transportation.</p>d<p>Cells not viable in culture.</p><p><b>Abbreviations</b>: ND = not done.</p>", "links"=>[], "tags"=>["vivo", "vitro", "dystrophin"], "article_id"=>874462, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0081302.t002", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_In_Vivo_and_In_Vitro_Dystrophin_Expression_/874462", "title"=>"In Vivo and In Vitro Dystrophin Expression.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-12-11 03:00:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/1310861"], "description"=>"<p>Serum CK levels at baseline (mean of screening and Day 1 pretreatment), end-of-treatment (Day 28), and follow-up (Day 56). P-values obtained from paired t-tests. <b>Abbreviations:</b> CK = creatine kinase, EOT = end of treatment, nmDMD = nonsense mutation Duchenne muscular dystrophy, SEM = standard error of the mean.</p>", "links"=>[], "tags"=>["creatine", "kinase"], "article_id"=>874458, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0081302.g004", "stats"=>{"downloads"=>1, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Serum_Creatine_Kinase_Concentrations_/874458", "title"=>"Serum Creatine Kinase Concentrations.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-12-11 03:00:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/1310869", "https://ndownloader.figshare.com/files/1310870", "https://ndownloader.figshare.com/files/1310871", "https://ndownloader.figshare.com/files/1310872"], "description"=>"<div><p>Background</p><p>Approximately 13% of boys with Duchenne muscular dystrophy (DMD) have a nonsense mutation in the dystrophin gene, resulting in a premature stop codon in the corresponding mRNA and failure to generate a functional protein. Ataluren (PTC124) enables ribosomal readthrough of premature stop codons, leading to production of full-length, functional proteins.</p><p>Methods</p><p>This Phase 2a open-label, sequential dose-ranging trial recruited 38 boys with nonsense mutation DMD. The first cohort (n = 6) received ataluren three times per day at morning, midday, and evening doses of 4, 4, and 8 mg/kg; the second cohort (n = 20) was dosed at 10, 10, 20 mg/kg; and the third cohort (n = 12) was dosed at 20, 20, 40 mg/kg. Treatment duration was 28 days. Change in full-length dystrophin expression, as assessed by immunostaining in pre- and post-treatment muscle biopsy specimens, was the primary endpoint.</p><p>Findings</p><p>Twenty three of 38 (61%) subjects demonstrated increases in post-treatment dystrophin expression in a quantitative analysis assessing the ratio of dystrophin/spectrin. A qualitative analysis also showed positive changes in dystrophin expression. Expression was not associated with nonsense mutation type or exon location. Ataluren trough plasma concentrations active in the <i>mdx</i> mouse model were consistently achieved at the mid- and high- dose levels in participants. Ataluren was generally well tolerated.</p><p>Interpretation</p><p>Ataluren showed activity and safety in this short-term study, supporting evaluation of ataluren 10, 10, 20 mg/kg and 20, 20, 40 mg/kg in a Phase 2b, double-blind, long-term study in nonsense mutation DMD.</p><p>Trial Registration</p><p><a href=\"http://www.clinicaltrials.gov/ct2/show/NCT00264888\" target=\"_blank\">ClinicalTrials.gov NCT00264888</a></p></div>", "links"=>[], "tags"=>["2a", "ataluren-mediated", "dystrophin", "patients", "nonsense", "mutation", "duchenne", "muscular"], "article_id"=>874466, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0081302.s001", "https://dx.doi.org/10.1371/journal.pone.0081302.s002", "https://dx.doi.org/10.1371/journal.pone.0081302.s003", "https://dx.doi.org/10.1371/journal.pone.0081302.s004"], "stats"=>{"downloads"=>19, "page_views"=>17, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Phase_2a_Study_of_Ataluren_Mediated_Dystrophin_Production_in_Patients_with_Nonsense_Mutation_Duchenne_Muscular_Dystrophy_/874466", "title"=>"Phase 2a Study of Ataluren-Mediated Dystrophin Production in Patients with Nonsense Mutation Duchenne Muscular Dystrophy", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2013-12-11 03:00:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/1310864"], "description"=>"<p>Subject 001–012 in the 20, 20, 40 mg/kg dose group was receiving prednisolone, a metabolite of prednisone. This subject is included in the prednisone group above. <b>Abbreviation:</b> AUC<sub>0–24</sub> = area under the plasma concentration-time curve from 0 to 24 hours.</p>", "links"=>[], "tags"=>["27", "ataluren", "concomitant", "corticosteroid"], "article_id"=>874461, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0081302.g006", "stats"=>{"downloads"=>3, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Dose_Normalized_Day_27_AUC_0_8211_24_Ataluren_Values_by_Concomitant_Corticosteroid_Use_All_Dose_Levels_Note_/874461", "title"=>"Dose-Normalized Day 27 AUC<sub>0–24</sub> Ataluren Values by Concomitant Corticosteroid Use (All Dose Levels). Note:", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-12-11 03:00:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/1310863"], "description"=>"<p>Blood samples were collected pre-dose and at 1, 2, 3, and 4 hours after the morning dose; pre-dose and at 1, 2, 3, and 4 hours after the midday dose; and pre-dose and at 1, 2, 3, 4, and 12 hours after the evening dose. Ataluren plasma concentrations were derived from a validated bioanalytical method. <b>Abbreviations:</b> SE = standard error.</p>", "links"=>[], "tags"=>["plasma", "concentrations"], "article_id"=>874460, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0081302.g005", "stats"=>{"downloads"=>1, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Ataluren_Plasma_Concentrations_Over_Time_/874460", "title"=>"Ataluren Plasma Concentrations Over Time.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-12-11 03:00:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/1310860"], "description"=>"<p>Percentage Change From Pretreatment in Dystrophin:Spectrin Ratio.</p>", "links"=>[], "tags"=>["pretreatment"], "article_id"=>874457, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0081302.g003", "stats"=>{"downloads"=>1, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Percentage_Change_From_Pretreatment_in_Dystrophin_Spectrin_Ratio_/874457", "title"=>"Percentage Change From Pretreatment in Dystrophin:Spectrin Ratio.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-12-11 03:00:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/1310858"], "description"=>"<p>In Vivo Dystrophin Expression by Immunofluorescence in Extensor Digitorum Brevis Muscle: Example of a Responder Subject.</p>", "links"=>[], "tags"=>["vivo", "dystrophin", "immunofluorescence", "extensor", "digitorum", "brevis", "responder"], "article_id"=>874455, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0081302.g002", "stats"=>{"downloads"=>2, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_In_Vivo_Dystrophin_Expression_by_Immunofluorescence_in_Extensor_Digitorum_Brevis_Muscle_Example_of_a_Responder_Subject_/874455", "title"=>"In Vivo Dystrophin Expression by Immunofluorescence in Extensor Digitorum Brevis Muscle: Example of a Responder Subject.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-12-11 03:00:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/1310866"], "description"=>"1<p>Ability to ambulate was based on investigator’s judgment.</p><p><b>Abbreviations</b>: SD = SD = standard deviation, UAA = uridine-adenosine-adenosine, UAG = uridine adenosine guanosine, UGA = uridine-guanosine-adenosine.</p>", "links"=>[], "tags"=>[], "article_id"=>874463, "categories"=>["Biological Sciences"], "users"=>["Richard S. Finkel", "Kevin M. Flanigan", "Brenda Wong", "Carsten Bonnemann", "Jacinda Sampson", "H. Lee Sweeney", "Allen Reha", "Valerie J. Northcutt", "Gary Elfring", "Jay Barth", "Stuart W. Peltz"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0081302.t001", "stats"=>{"downloads"=>1, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_Subject_Characteristics_/874463", "title"=>"Baseline Subject Characteristics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-12-11 03:00:06"}

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Relative Metric

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