Favorable outcomes for patients with refractory systemic lupus erythematosus treated with rituximab as evidenced with a follow-up of ≥ 10 years: a real-world evidence study.

Treatment of Systemic Lupus Erythematosus (SLE) remains challenging. The aim of this real-world evidence study of patients with refractory SLE treated with rituximab (RTX) was to explore for any potential long-term effect(s) of this particular B cell depletion approach. This study included patients with SLE who had i) received at least 1 cycle of RTX and had ii) an at least 10 yr of follow-up after their first RTX infusion. Outcomes were assessed at 1 year and at their latest evaluation that was ≥ 10 yr after RTX treatment initiation. In cases where the SLE Disease Activity Index 2000 (cSLEDAI-2 k) was employed, a response was defined as a cSLEDAI-2 k of less than 4 in cases where the cSLEDAI-2 k was ≥ 4. In cases where the cSLEDAI-2 k was 2-4 at baseline, a response was defined as a cSLEDAI-2 k of 0. RTX was administered in 62 patients with SLE. For this real-world evidence study 23 patients (25 cases) with SLE (all Caucasian female, age range: 14-72 yr, mean: 31 yr) with active or relapsing disease, fulfilling inclusion criteria were enrolled. RTX treatment was associated with a response rate of 68.75% after 1 yr and 75% after ≥ 10 yr. The median cSLEDAI-2 K score decreased from 5.83 ± 3.70 at baseline to 1.95 ± 2.40 (p < 0.001) at 1 yr and to 2.37 ± 3.00 (p < 0.001) at the ≥ 10 yr time-point of follow-up. Our data suggest that RTX may indeed represent an alternative therapeutic option in patients with SLE refractory to standard treatment with an acceptable safety profile.