SMALL CHANGES IN OUTPATIENT LUPUS ACTIVITY ARE BETTER DETECTED BY CLINICAL INSTRUMENTS THAN BY LABORATORY TESTS

Objective, To evaluate and compare responsiveness of laboratory and cl inical measures over 4 months in outpatient systemic lupus erythematos us (SLE). Methods, We studied 23 patients with SLE at monthly interval s during 4 mo and collected demographic data, prednisone dose, global patient and physician assessment of disease activity on 10 cm visual a nalog scales (VAS), scores on 3 clinical measures of lupus disease act ivity [SLE disease activity index (SLEDAI), SLE activity measure (SLAM ), lupus activity index (LAI)], and results of 5 routine laboratory te sts [erythrocyte sedimentation rate (ESR), anti-dsDNA, C3, C4, circula ting immune complexes]. We calculated correlations between a particula r measure and our gold standard (physician's VAS) for individual patie nts and pooled this information using a novel application of the meta- analytic approach. Results, The range of disease activity by patient a nd physician VAS varied from inactive to moderately active. Change in patient global assessment and all 3 clinical measures showed significa nt positive correlations with change in physician VAS (p < 0.05). Chan ge in ESR? anti-dsDNA, or level of C3, C4, or circulating immune compl exes did not correlate with change in physician VAS, Conclusion, Clini cal measures of disease activity in SLE are more responsive to small c hanges than traditional laboratory tests. All 3 clinical measures appe ared to perform equally well, At least one SLE disease activity measur e should be used in future SLE trials. The new analytic method will li kely be of value in similar evaluations of responsiveness in other dis eases.