USE OF RITUXIMAB IN PATIENTS WITH SYSTEMIC MANIFESTATIONS OF PRIMARY SJOGREN'S SYNDROME

Abstract

The data on the efficacy of rituximab (RTM) in systemic manifestations of primary Sjogren's syndrome (PSS) are limited by single trials. Objective: to evaluate the efficacy of RTM in patients with the systemic manifestations of PSS. Subjects and methods. RTM therapy was performed in 24 patients with the systemic manifestations of PSS. The mean dose of a RTM for induction therapy cycle was 2±0.3 g. Nine patients received RTM monotherapy and 12 were treated with RTM in combination with cyclophosphan. A complete clinical response was defined as complete disappearance of pre-treatment clinical manifestations; a partial one was interpreted as more than 50% improvements in some signs or cessation of half of the existing signs. A complete immunological response implied normalization of a low baseline C4 level, disappearance of cryoglobulinemia and monoclonal immunoglobulins in serum and/or their light chains in urine; a partial one meant normalization or cessation of more than half of the initial signs. The remaining cases were regarded as no treatment response. A recurrence was considered to be the reoccurrence of at least one pretreatment sign during a 3-month or more follow-up. Results. At 3 months after RTM therapy, a complete or partial clinical response was observed in 71.4% (15/21) and 19% (4/21) of cases, respectively. A complete or partial immunological response was obtained in 50% (10/20) and 25 (5/20) of the patients, respectively. At 6 months, a clinical and immunological recurrence was noted in 25% (5/20) and 33% (6/18) of the patients, respectively. There was a reduction in median ESSDAI from 8 (7–10) (median, 25th and 75th percentiles) to 3 (2–4) at 3–6 months (p<0.001). After RTM therapy, medium serum BAFF concentrations in 9 patients decreased from 1.71 (0.66–2.73) to 0.68 (0.62–2.58) ng/ml (normal value <0.8 ng/ml). Conclusion. RTM shows good efficacy in treating systemic forms of PSS.