title: Progress in defining clinically meaningful changes for clinical trials in nonrenal manifestations of SLE disease activity.
abstract: Since the 2002 Dusseldorf meeting, one new agent, Benlysta, has been approved by the US Food and Drug Administration for systemic lupus erythematosus. Experiences from the field in conducting trials of all the agents tested during this period have provided valuable practical insights. There has been incremental progress in defining the minimal clinically important difference (MCID) of key disease manifestations and the view is largely that of the health care providers and not that of the person suffering the disease. This basic methodological work on the MCID should improve the efficiency and the clinical relevance of future trials and their design.
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-ro, Seongdong-gu, Seoul, 04763, Republic of Korea.|Department of Aging, Brigham and Women's Hospital, Section of Rheumatology, 75 Francis St., Boston, MA, 02115, USA.|VA Healthcare System, 150 S Huntington Ave, Jamaica Plain, MA, 02130, USA.
authors.forename: Chan-Bum
authors.initials: CB
authors.lastname: Choi
authors.affiliation: Department of Aging, Brigham and Women's Hospital, Section of Rheumatology, 75 Francis St., Boston, MA, 02115, USA. mhliang@partners.org.|Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA. mhliang@partners.org.
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Liang
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-ro, Seongdong-gu, Seoul, 04763, Republic of Korea.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods*; D003072:Cognition Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D018450:Disease Progression; D005221:Fatigue / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology*; D012871:Skin Diseases / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C511911:belimumab