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Purpose: Previous reports have suggested that a substantial portion of SLE patients (pts) have CD4+ lymphopenia. We evaluated the proportion of SLE pts with CD4+ lymphopenia enrolled in EXPLORER (extra-renal SLE) and LUNAR (lupus nephritis) and the relationship of sustained CD4+ lymphopenia (CD4+ T cell counts < 200/uL) to serious infections.
Methods: All pts enrolled in EXPLORER and LUNAR had moderate-to-severe disease activity, were treated with a background immunosuppressant (mycophenolate mofetil, azathioprine, or methotrexate) plus corticosteroids, and were randomized to either placebo or rituximab (1000 mg) given on days 1, 15, 168, and 182. The levels of CD4+ T cells at baseline and over 1 year were evaluated on days 1, 15, 28, 84,112, 168, 182, 196, 252, 308 and 364. Pts with sustained lymphopenia over 2 consecutive visits, at least 4 weeks apart, were evaluated for serious infection rates.
Results: At baseline, the mean level of CD4+ T cells for the combined cohort (n=401) was 524±387 cells/uL. Sixty-four (16.3%) pts had CD4+ counts < 200 cells/uL. Although CD4+ counts initially decreased to a mean level of 456.9 cells/uL at Day 28, likely due to protocol-mandated steroid administration, they were not significantly different from baseline at week 52 (figure). The mean percentage change from baseline to week 52 was -16.2±4.6%. During the trial, 100 (24.9%) pts experienced sustained lymphopenia. The mean duration of lymphopenia was 111.3 +/- 83.7 days. There was no significant difference in rate of serious infections between sustained lymphopenia pts, who had 22 events over 103.2 patient-years (p-y) (21.3/100 p-y, 95% CI: 14.0, 32.4) of follow-up, and those without sustained lymphopenia, who had 438 events over 299.5 p-y (16.0/100 p-y, 95% CI: 12.1, 21.3; p=0.27) of follow-up.
Conclusions: Sixteen percent of SLE pts had CD4+ counts < 200 cells/uL at baseline. Although CD4+ counts fluctuated over time, likely due to concomitant therapy, levels stabilized near baseline values by the end of the treatment period. Sustained CD4+ lymphopenia occurred in a quarter of pts but did not appear to significantly increase the risk of serious infections. Further analysis by treatment group will be conducted.
Disclosure: K. M. Latinis, Genentech , 2, Genentech , 5, Genentech, Centocor , 6 ; E. F. Chakravarty, Genentech , 5 ; P. Brunetta, Genentech , 3 ; H. Hsieh, Genentech , 3 ; J. Garg, Genentech , 3 ; R. Maciuca, Genentech , 3 ; B. Wagner, Genentech , 3 .