Background The Childhood Arthritis and Rheumatology Research Alliance (CARRA) aims to collect meaningful clinical data on all children affected by rheumatic disease in North America as a basis for performing high quality clinical and translational research. The new CARRA Registry (building on a prior CARRA registry with a minimal dataset) has enrolled pediatric patients with systemic lupus erythematosus (SLE) and related conditions since March 2017. We sought to describe the population enrolled thus far and to demonstrate the breadth and potential value of the data generated by the new CARRA Registry.
Methods We requested de-identified counts of several fields collected from the case report forms for subjects with SLE. Patients were eligible for enrollment in the new CARRA registry if they were diagnosed with SLE prior to the age of 18 and had either 1) a new diagnosis of SLE or 2) a flare of lupus nephritis within two years prior to the baseline visit. IRB approval was not required for this data request.
Results To date, 184 patients (pts) have been enrolled; 156 (85%) are female. There are 46 black pts, 45 Hispanic pts, 47 white pts, 18 Asian pts and 16 pts were >1 race. Over half the pts have private health insurance (n=95, 52%) and 60 pts (33%) have Medicaid. Autoantibody positivity was prevalent: 175 pts (95%) were ANA positive, 109 (59%) dsDNA positive, and 87 (47%) anti-Smith positive. Positivity for anti-RNP, anti-Ro, anti-La, and APLs ranged from 15% to 51%. At the baseline visit, the mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI, n=166) score was 5.5±6.3, median=4 (range 0–37; IQR 0.25–8). The mean Systemic Lupus International Collaborating Clinic Damage Index (SLICC DI, n=150) score was 0.4, median=0 (range 0–7). Approximately one quarter of pts (n=50) were being treated for lupus nephritis at the time of the baseline visit. Manifestations of SLE at the baseline visit were varied (table 1) but serologic disease, mucocutaneous disease and active nephritis were the most prevalent.
Conclusions Nearly 200 SLE pts have been enrolled in the new CARRA Registry to date. This is a multi-racial cohort with moderate disease activity and varied disease manifestations. Further enrollment will continue to build a robust data source to study disease course and outcomes in a pediatric SLE inception cohort.
Acknowledgements The authors wish to acknowledge the Arthritis Foundation for ongoing financial support of CARRA and the CARRA Registry.
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