Objectives To assess the long-term efficacy and safety of rituximab (RTM) in patients with systemic lupus erythematosus (SLE) resistant to standard therapy.
Methods 97 patients with relapsing/refractory systemic lupus erythematosus received rituximab. The mean time of follow-up was 24months (6-72months). The most common clinical manifestations of SLE were lupus nephritis (LN) (62%), skin involvement (33%) and neurological symptoms (22,7%). SLE activity was assessed by SLEDAI2K. The following terms such as partial response (PR), complete response (CR) and exacerbation were used. Exacerbation was classified as moderate and severe using the SFI index.
Results 78% of 97 patients had depleted peripheral B-cells. 84% of patients achieved a clinical response (CR-56%, PR-28%) after repeated courses of RTM during the long-term follow-up. The exacerbation was occurred in 24 (24,7%) patients, the median time of exacerbation was 12[12-24]months after therapy with RTM: 17,5% with LN (the median time of exacerbation was 12[12-24]months), 7,2% with extrarenal SLE (the median time of exacerbation was 18[6-48]months). In 24 patients with exacerbation B-cells recovered after 6[3-12]months. CR was observed more frequently in patients with complete depletion of B-cell (n=35) than in group of patients (n=20) with B-cell recovery (65,7% and 30% respectively, p=0,03). CR was observed significantly more frequently in patients after repeated courses of rituximab, compared with a group of patients who received only one course of therapy (p=0,05) (table 1).
Clinical improvement was reflected by reduction of disease activity index SLEDAI2K, normalization of laboratory parameters and decreasing the daily dose of prednisolone during the long-term follow-up. In most of the patients the first and repeated courses of RTM therapy was well tolerated.
Conclusions RTM had a high rate of efficacy in relapsing and refractory SLE. There was no evidence of an increased risk of infections or increased reporting rates of any types of adverse effects during the 6 years of observation.
Disclosure of Interest None declared