Abatacept for lupus nephritis: Alternative definitions of complete response support conflicting conclusions
Arthritis & Rheumatism, 07/27/2012
Wofsy D et al. – The choice of definition of complete response can determine whether a lupus nephritis trial is interpreted as a success or a failure. This analysis provides an evidence–based rationale for choosing among alternative definitions, and it offers a strong rationale for conducting further studies of abatacept in lupus nephritis.Methods
- Subjects in BMS study number IM101075 received either abatacept or placebo on a background of mycophenolate mofetil and corticosteroids.
- Using data from this trial, the authors assessed CR rates at 12 months according to five sets of criteria from:
- (1) the trial protocol;
- (2) the ALMS trial of mycophenolate mofetil;
- (3) the LUNAR trial of rituximab;
- (4) an ongoing NIH trial of abatacept (ACCESS);
- (5) published recommendations of the American College of Rheumatology.
- The per–protocol CR definition showed no difference among groups.
- In contrast, the ALMS, LUNAR, and ACCESS definitions each showed significantly higher CR rates in both treatment groups relative to control.
- The largest differences were observed using the LUNAR criteria (CR rates of 6% among control subjects, compared to 22% and 24% in the two abatacept groups).