A Systematic Review Comparing Experimental Design of Animal and Human Methotrexate Efficacy Studies for Rheumatoid Arthritis: Lessons for the Translational Value of Animal Studies.

Autor: Leenaars C; SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands.; Department of Population Health Science, unit Animals in Science and Society, Utrecht University, 3508 TD Utrecht, The Netherlands.; Institute for Laboratory Animal Science, Hannover Medical School, 30625 Hannover, Germany., Stafleu F; Ethics Institute, Utrecht University, 3508 TC Utrecht, the Netherlands., de Jong D; SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands., van Berlo M; SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands., Geurts T; SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands., Coenen-de Roo T; Central Animal Facility, Leiden University Medical Centre, 2300 RC Leiden, The Netherlands., Prins JB; Biological Research Facility, The Francis Crick Institute, London NW1 1AT, UK., Kempkes R; SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands., Elzinga J; SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands., Bleich A; Institute for Laboratory Animal Science, Hannover Medical School, 30625 Hannover, Germany., de Vries R; SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands., Meijboom F; Department of Population Health Science, unit Animals in Science and Society, Utrecht University, 3508 TD Utrecht, The Netherlands.; Ethics Institute, Utrecht University, 3508 TC Utrecht, the Netherlands., Ritskes-Hoitinga M; SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands.
Jazyk: angličtina
Zdroj: Animals : an open access journal from MDPI [Animals (Basel)] 2020 Jun 17; Vol. 10 (6). Date of Electronic Publication: 2020 Jun 17.
DOI: 10.3390/ani10061047
Abstrakt: Increased awareness and understanding of current practices in translational research is required for informed decision making in drug development. This paper describes a systematic review of methotrexate for rheumatoid arthritis, comparing trial design between 147 animal and 512 human studies. Animal studies generally included fewer subjects than human studies, and less frequently reported randomisation and blinding. In relation to life span, study duration was comparable for animals and humans, but included animals were younger than included humans. Animal studies often comprised males only (61%), human studies always included females (98% included both sexes). Power calculations were poorly reported in both samples. Analyses of human studies more frequently comprised Chi-square tests, those of animal studies more frequently reported analyses of variance. Administration route was more variable, and more frequently reported in animal than human studies. Erythrocyte sedimentation rate and c-reactive protein were analysed more frequently in human than in animal studies. To conclude, experimental designs for animal and human studies are not optimally aligned. However, methotrexate is effective in treating rheumatoid arthritis in animal models and humans. Further evaluation of the available evidence in other research fields is needed to increase the understanding of translational success before we can optimise translational strategies.
Databáze: MEDLINE
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