Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials
Publication Date
May 11, 2016
Journal
PLOS ONE
Authors
Jonathan West, Simon Ogston & John Foerster
Volume
11
Issue
5
Pages
e0153740
DOI
https://dx.plos.org/10.1371/journal.pone.0153740
Publisher URL
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0153740
Web of Science
000376587300077
Scopus
84969933365
Mendeley
http://www.mendeley.com/research/safety-efficacy-methotrexate-psoriasis-metaanalysis-published-trials
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Mendeley | Further Information

{"title"=>"Safety and efficacy of methotrexate in psoriasis: A meta-analysis of published trials", "type"=>"journal", "authors"=>[{"first_name"=>"Jonathan", "last_name"=>"West", "scopus_author_id"=>"57189379685"}, {"first_name"=>"Simon", "last_name"=>"Ogston", "scopus_author_id"=>"7005617963"}, {"first_name"=>"John", "last_name"=>"Foerster", "scopus_author_id"=>"22947207800"}], "year"=>2016, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "pmid"=>"27380015", "scopus"=>"2-s2.0-84969933365", "doi"=>"10.1371/journal.pone.0153740", "sgr"=>"84969933365", "pui"=>"610398000"}, "id"=>"ddb68958-631e-3fcd-a28f-7942407f3be3", "abstract"=>"Background: Methotrexate (MTX) has been used to treat psoriasis for over half a century. Even so, clinical data characterising its efficacy and safety are sparse. Objective: In order to enhance the available evidence, we conducted two meta-analyses, one for efficacy and one for safety outcomes, respectively, according to PRISMA checklist. (Data sources, study criteria, and study synthesis methods are detailed in Methods). Results: In terms of efficacy, only eleven studies met criteria for study design and passed a Cochrane risk of bias analysis. Based on this limited dataset, 45.2% [95% confidence interval 34.1-60.0] of patients achieve PASI75 at primary endpoint (12 or 16 weeks, respectively, n = 705 patients across all studies), compared to a calculated PASI75 of 4.4 [3.5-5.6] for placebo, yielding a relative risk of 10.2 [95% C.I. 7.1-14.7]. For safety outcomes, we extended the meta-analysis to include studies employing the same dose range of MTX for other chronic inflammatory conditions, e.g. rheumatoid arthritis, in order not to maximise capture of relevant safety data. Based on 2763 patient safety years, adverse events (AEs) were found treatment limiting in 6.9 +/- 1.4% (mean +/- s.e.) of patients treated for six months, with an adverse effect profile largely in line with that encountered in clinical practice. Finally, in order to facilitate prospective clinical audit and to help generate long-term treatment outcomes under real world conditions, we also developed an easy to use documentation form to be completed by patients without requirement for additional staff time. Limitations: Meta-analyses for efficacy and safety, respectively, employed non-identical selection criteria. Conclusions: These meta-analyses summarise currently available evidence on MTX in psoriasis and should be of use to gauge whether local results broadly fall within outcomes.", "link"=>"http://www.mendeley.com/research/safety-efficacy-methotrexate-psoriasis-metaanalysis-published-trials", "reader_count"=>19, "reader_count_by_academic_status"=>{"Researcher"=>6, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>2, "Other"=>3, "Student > Master"=>1, "Student > Bachelor"=>1, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Researcher"=>6, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>2, "Other"=>3, "Student > Master"=>1, "Student > Bachelor"=>1, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Nursing and Health Professions"=>1, "Biochemistry, Genetics and Molecular Biology"=>2, "Medicine and Dentistry"=>12, "Agricultural and Biological Sciences"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Business, Management and Accounting"=>1, "Social Sciences"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>12}, "Social Sciences"=>{"Social Sciences"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>2}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"Netherlands"=>1, "United Kingdom"=>1}, "group_count"=>1}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/5225044"], "description"=>"<p>Adverse effects associated with MTX treatments in published trials<a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0153740#t002fn001\" target=\"_blank\"><sup>1</sup></a>.</p>", "links"=>[], "tags"=>["2763 patient safety years", "PASI 75", "Trials Background Methotrexate", "PRISMA", "use documentation form", "criteria", "study synthesis methods", "safety outcomes", "C.I", "efficacy", "MTX", "AE"], "article_id"=>3379744, "categories"=>["Medicine", "Biotechnology", "Immunology", "Mathematical Sciences not elsewhere classified", "Cancer", "Infectious Diseases", "Virology"], "users"=>["Jonathan West", "Simon Ogston", "John Foerster"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0153740.t002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Adverse_effects_associated_with_MTX_treatments_in_published_trials_sup_1_sup_/3379744", "title"=>"Adverse effects associated with MTX treatments in published trials<sup>1</sup>.", "pos_in_sequence"=>6, "defined_type"=>3, "published_date"=>"2016-05-11 05:59:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/5225008"], "description"=>"<p>The risk ratio shown refers to the PASI75 outcome reported at 12 or 16 weeks, respectively, assuming a random effects model (<a href=\"http://ije.oxfordjournals.org/content/39/2/421.full\" target=\"_blank\">http://ije.oxfordjournals.org/content/39/2/421.full</a>). One study (Dogra 2012) is listed twice because two distinct sub-cohorts were dosed differently (10 mg vs 25 mg), as described in the text.</p>", "links"=>[], "tags"=>["2763 patient safety years", "PASI 75", "Trials Background Methotrexate", "PRISMA", "use documentation form", "criteria", "study synthesis methods", "safety outcomes", "C.I", "efficacy", "MTX", "AE"], "article_id"=>3379717, "categories"=>["Medicine", "Biotechnology", "Immunology", "Mathematical Sciences not elsewhere classified", "Cancer", "Infectious Diseases", "Virology"], "users"=>["Jonathan West", "Simon Ogston", "John Foerster"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0153740.g002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Forest_plot_of_efficacy_of_MTX_in_psoriasis_as_reported_in_the_published_clinical_studies_shown_in_Table_4_/3379717", "title"=>"Forest plot of efficacy of MTX in psoriasis as reported in the published clinical studies shown in Table 4.", "pos_in_sequence"=>3, "defined_type"=>1, "published_date"=>"2016-05-11 05:59:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/5225050"], "description"=>"<p>Treatment limiting AEs occurring under methotrexate treatment<a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0153740#t003fn001\" target=\"_blank\"><sup>1</sup></a>.</p>", "links"=>[], "tags"=>["2763 patient safety years", "PASI 75", "Trials Background Methotrexate", "PRISMA", "use documentation form", "criteria", "study synthesis methods", "safety outcomes", "C.I", "efficacy", "MTX", "AE"], "article_id"=>3379750, "categories"=>["Medicine", "Biotechnology", "Immunology", "Mathematical Sciences not elsewhere classified", "Cancer", "Infectious Diseases", "Virology"], "users"=>["Jonathan West", "Simon Ogston", "John Foerster"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0153740.t003", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Treatment_limiting_AEs_occurring_under_methotrexate_treatment_sup_1_sup_/3379750", "title"=>"Treatment limiting AEs occurring under methotrexate treatment<sup>1</sup>.", "pos_in_sequence"=>7, "defined_type"=>3, "published_date"=>"2016-05-11 05:59:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/5224945", "https://ndownloader.figshare.com/files/5224984", "https://ndownloader.figshare.com/files/5224981", "https://ndownloader.figshare.com/files/5224975", "https://ndownloader.figshare.com/files/5224972", "https://ndownloader.figshare.com/files/5224966", "https://ndownloader.figshare.com/files/5224963", "https://ndownloader.figshare.com/files/5224960", "https://ndownloader.figshare.com/files/5224954", "https://ndownloader.figshare.com/files/5224948", "https://ndownloader.figshare.com/files/5224990"], "description"=>"<div><p>Background</p><p>Methotrexate (MTX) has been used to treat psoriasis for over half a century. Even so, clinical data characterising its efficacy and safety are sparse.</p><p>Objective</p><p>In order to enhance the available evidence, we conducted two meta-analyses, one for efficacy and one for safety outcomes, respectively, according to PRISMA checklist. (Data sources, study criteria, and study synthesis methods are detailed in Methods).</p><p>Results</p><p>In terms of efficacy, only eleven studies met criteria for study design and passed a Cochrane risk of bias analysis. Based on this limited dataset, 45.2% [95% confidence interval 34.1–60.0] of patients achieve PASI75 at primary endpoint (12 or 16 weeks, respectively, n = 705 patients across all studies), compared to a calculated PASI75 of 4.4 [3.5–5.6] for placebo, yielding a relative risk of 10.2 [95% C.I. 7.1–14.7]. For safety outcomes, we extended the meta-analysis to include studies employing the same dose range of MTX for other chronic inflammatory conditions, e.g. rheumatoid arthritis, in order not to maximise capture of relevant safety data. Based on 2763 patient safety years, adverse events (AEs) were found treatment limiting in 6.9 ± 1.4% (mean ± s.e.) of patients treated for six months, with an adverse effect profile largely in line with that encountered in clinical practice. Finally, in order to facilitate prospective clinical audit and to help generate long-term treatment outcomes under real world conditions, we also developed an easy to use documentation form to be completed by patients without requirement for additional staff time.</p><p>Limitations</p><p>Meta-analyses for efficacy and safety, respectively, employed non-identical selection criteria.</p><p>Conclusions</p><p>These meta-analyses summarise currently available evidence on MTX in psoriasis and should be of use to gauge whether local results broadly fall within outcomes.</p></div>", "links"=>[], "tags"=>["2763 patient safety years", "PASI 75", "Trials Background Methotrexate", "PRISMA", "use documentation form", "criteria", "study synthesis methods", "safety outcomes", "C.I", "efficacy", "MTX", "AE"], "article_id"=>3379687, "categories"=>["Medicine", "Biotechnology", "Immunology", "Mathematical Sciences not elsewhere classified", "Cancer", "Infectious Diseases", "Virology"], "users"=>["Jonathan West", "Simon Ogston", "John Foerster"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0153740.s001", "https://dx.doi.org/10.1371/journal.pone.0153740.s010", "https://dx.doi.org/10.1371/journal.pone.0153740.s009", "https://dx.doi.org/10.1371/journal.pone.0153740.s008", "https://dx.doi.org/10.1371/journal.pone.0153740.s007", "https://dx.doi.org/10.1371/journal.pone.0153740.s006", "https://dx.doi.org/10.1371/journal.pone.0153740.s005", "https://dx.doi.org/10.1371/journal.pone.0153740.s004", "https://dx.doi.org/10.1371/journal.pone.0153740.s003", "https://dx.doi.org/10.1371/journal.pone.0153740.s002", "https://dx.doi.org/10.1371/journal.pone.0153740.s011"], "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Safety_and_Efficacy_of_Methotrexate_in_Psoriasis_A_Meta-Analysis_of_Published_Trials/3379687", "title"=>"Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials", "pos_in_sequence"=>1, "defined_type"=>4, "published_date"=>"2016-05-11 05:59:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/5225014"], "description"=>"<p>All individual study data and forest plots for all individual AE’s are detailed in the Supplement. Underlined studies were conducted for psoriasis as indication.</p>", "links"=>[], "tags"=>["2763 patient safety years", "PASI 75", "Trials Background Methotrexate", "PRISMA", "use documentation form", "criteria", "study synthesis methods", "safety outcomes", "C.I", "efficacy", "MTX", "AE"], "article_id"=>3379723, "categories"=>["Medicine", "Biotechnology", "Immunology", "Mathematical Sciences not elsewhere classified", "Cancer", "Infectious Diseases", "Virology"], "users"=>["Jonathan West", "Simon Ogston", "John Foerster"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0153740.g003", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Forest_plot_of_all_non_treatment_limiting_adverse_effects_Fig3a_as_reported_in_the_studies_summarised_in_Table_2_as_well_as_limiting_AEs_Fig_3b_/3379723", "title"=>"Forest plot of all non treatment limiting adverse effects (Fig3a), as reported in the studies summarised in Table 2, as well as limiting AEs (Fig 3b).", "pos_in_sequence"=>4, "defined_type"=>1, "published_date"=>"2016-05-11 05:59:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/5225056"], "description"=>"<p>Assessment of bias-profile in published trials on MTX efficacy in psoriasis<a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0153740#t004fn001\" target=\"_blank\"><sup>1</sup></a>.</p>", "links"=>[], "tags"=>["2763 patient safety years", "PASI 75", "Trials Background Methotrexate", "PRISMA", "use documentation form", "criteria", "study synthesis methods", "safety outcomes", "C.I", "efficacy", "MTX", "AE"], "article_id"=>3379759, "categories"=>["Medicine", "Biotechnology", "Immunology", "Mathematical Sciences not elsewhere classified", "Cancer", "Infectious Diseases", "Virology"], "users"=>["Jonathan West", "Simon Ogston", "John Foerster"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0153740.t004", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Assessment_of_bias-profile_in_published_trials_on_MTX_efficacy_in_psoriasis_sup_1_sup_/3379759", "title"=>"Assessment of bias-profile in published trials on MTX efficacy in psoriasis<sup>1</sup>.", "pos_in_sequence"=>8, "defined_type"=>3, "published_date"=>"2016-05-11 05:59:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/5225032"], "description"=>"<p>Published studies reporting MTX safety outcomes relevant for psoriasis treatment<a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0153740#t001fn001\" target=\"_blank\"><sup>1</sup></a>.</p>", "links"=>[], "tags"=>["2763 patient safety years", "PASI 75", "Trials Background Methotrexate", "PRISMA", "use documentation form", "criteria", "study synthesis methods", "safety outcomes", "C.I", "efficacy", "MTX", "AE"], "article_id"=>3379735, "categories"=>["Medicine", "Biotechnology", "Immunology", "Mathematical Sciences not elsewhere classified", "Cancer", "Infectious Diseases", "Virology"], "users"=>["Jonathan West", "Simon Ogston", "John Foerster"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0153740.t001", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Published_studies_reporting_MTX_safety_outcomes_relevant_for_psoriasis_treatment_sup_1_sup_/3379735", "title"=>"Published studies reporting MTX safety outcomes relevant for psoriasis treatment<sup>1</sup>.", "pos_in_sequence"=>5, "defined_type"=>3, "published_date"=>"2016-05-11 05:59:59"}
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PMC Usage Stats

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Relative Metric

{"start_date"=>"2016-01-01T00:00:00Z", "end_date"=>"2016-12-31T00:00:00Z", "subject_areas"=>[]}
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