PMID- 27168193 OWN - NLM STAT- MEDLINE DCOM- 20170706 LR - 20181113 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 11 IP - 5 DP - 2016 TI - Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials. PG - e0153740 LID - 10.1371/journal.pone.0153740 [doi] LID - e0153740 AB - 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. FAU - West, Jonathan AU - West J AD - University of Dundee, College of Medicine, Dentistry, and Nursing, Dundee, Scotland. FAU - Ogston, Simon AU - Ogston S AD - University of Dundee, College of Medicine, Dentistry, and Nursing, Dundee, Scotland. FAU - Foerster, John AU - Foerster J AD - University of Dundee, College of Medicine, Dentistry, and Nursing, Dundee, Scotland. AD - Department of Dermatology and Photobiology, NHS Tayside, Dundee, Scotland. LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20160511 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Dermatologic Agents) RN - 0 (Immunosuppressive Agents) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM EIN - PLoS One. 2016;11(7):e0158928. PMID: 27380015 MH - Arthritis, Rheumatoid/drug therapy MH - Dermatologic Agents/*administration & dosage/adverse effects MH - Humans MH - Immunosuppressive Agents/*administration & dosage/adverse effects MH - Methotrexate/*administration & dosage/adverse effects MH - Nausea/chemically induced/diagnosis MH - Opportunistic Infections/chemically induced/diagnosis MH - Oral Ulcer/chemically induced/diagnosis MH - Patient Safety MH - Psoriasis/*drug therapy MH - Risk MH - Treatment Outcome PMC - PMC4864230 COIS- Competing Interests: The authors have declared that no competing interests exist. EDAT- 2016/05/12 06:00 MHDA- 2017/07/07 06:00 PMCR- 2016/05/11 CRDT- 2016/05/12 06:00 PHST- 2015/04/20 00:00 [received] PHST- 2016/04/04 00:00 [accepted] PHST- 2016/05/12 06:00 [entrez] PHST- 2016/05/12 06:00 [pubmed] PHST- 2017/07/07 06:00 [medline] PHST- 2016/05/11 00:00 [pmc-release] AID - PONE-D-15-17092 [pii] AID - 10.1371/journal.pone.0153740 [doi] PST - epublish SO - PLoS One. 2016 May 11;11(5):e0153740. doi: 10.1371/journal.pone.0153740. eCollection 2016.