NDLI: Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Wofsy, David Hillson, Jan L. Diamond, Betty
Description	Country affiliation: United States Author Affiliation: Wofsy D ( University of California, San Francisco, USA. wofsyd@medsch.ucsf.edu)
Abstract	OBJECTIVE: Recent clinical trials in lupus nephritis have all used different criteria to assess complete response. The objective of this analysis was to compare several previously proposed criteria, using the same data set from a large trial of abatacept in lupus nephritis (IM101075). In so doing, we sought to determine which criteria are most sensitive to differences among treatment groups and to further examine the potential of abatacept in lupus nephritis. METHODS: Patients in the IM101075 trial received abatacept at 1 of 2 different dose regimens or placebo, both on a background of mycophenolate mofetil and corticosteroids. Using data from this trial, we assessed rates of complete response at 12 months according to 5 sets of criteria, from 1) the trial protocol, 2) the Aspreva Lupus Management Study (ALMS) trial of mycophenolate mofetil, 3) the Lupus Nephritis Assessment with Rituximab (LUNAR) trial of rituximab, 4) an ongoing National Institutes of Health trial of abatacept (Abatacept and Cyclophosphamide Combination: Efficacy and Safety Study [ACCESS]), and 5) published recommendations of the American College of Rheumatology. RESULTS: According to the complete response definition from the IM101075 study protocol, there was no difference among treatment groups in the IM101075 study. In contrast, according to the ALMS, LUNAR, and ACCESS criteria, rates of complete response among patients in the IM101075 study were higher in both treatment groups relative to control. The largest differences were obtained with use of the LUNAR criteria (complete response rate of 6% in the control group, compared to 22% and 24% in the 2 abatacept groups). CONCLUSION: The choice of definition of complete response can determine whether a lupus nephritis trial is interpreted as a success or a failure. The results of this analysis provide an evidence-based rationale for choosing among alternative definitions and offer a strong rationale for conducting further studies of abatacept in lupus nephritis.
File Format	HTM / HTML
ISSN	00043591
e-ISSN	15290131
Journal	Arthritis & Rheumatism
Issue Number	11
Volume Number	64
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2012-11-01
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Creatinine Urine Research Support, Non-u.s. Gov't Clinical Trial, Phase Ii Immunosuppressive Agents Drug Therapy Administration & Dosage Randomized Controlled Trial Clinical Trial, Phase Iii Immunoconjugates Abatacept Lupus Nephritis Dose-response Relationship, Drug Evidence-based Medicine Multicenter Study Discipline Rheumatic Diseases Proteinuria
Content Type	Text
Resource Type	Article
Subject	Immunology and Allergy Immunology Pharmacology (medical) Rheumatology

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