Rituximab is safe and effective in some Primary Sjӧgren's syndrome patients, according to Italian investigators who compared the drug head-to-head with conventional antirheumatic therapy.
Carubbi F, Cipriani P, Marrelli A, et al.Efficacy and safety of rituximab treatment in early primary Sjgren's syndrome: a prospective, multi-center, follow-up study. Arthritis Research & Therapy (2013) doi:10.1186/ar4359. Published October 30, 2013.
Primary SjÃ¶gren's syndrome (pSS) patients with systemic extra-glandular involvement may see greater and quicker benefits from rituximab therapy than fromconventional antirheumatic disease modifying drugs (DMARDs), according to an Italian study.
The researchers said they believe the data provides additional biological basis to employ RTX in extra-glandular pSS.
The prospective study involved 41 consecutive pSS patients with early, active disease and extra-glandular problems. They were treated at rheumatology centers at two universities and followed for 120 weeks (19 received rituximab; 22 received DMARDs).
Almost all patients were women, with a mean age of 40 (rituximab) or 49 (DMARDs), a mean disease duration of 13-14 months and with similar clinical features.
Rituximab patients received 1,000 mg intravenously at day 1 and at day 15 to complete a course of therapy every 24 weeks, for a total of six courses of therapy.
All patients were pretreated with IV 40 mg methylprednisolone, 1,000 mg of the oral analgesic paracetamol, and IV 10 mg of the antihistamine chlorpheniramine.
Mean baseline EULAR Sj?gren's syndrome disease activity index (ESSDAI) scores were similar for both groups (20.4 in rituximab arm;19.8 in DMARDs arm).
Rituximab therapy displayed a stronger and more significant decrease in ESSDAI thanDMARDs from the second course of therapy to week 120 (mean 5.2 vs 8.8).
Trends were similar in visual analogic scales for global disease activity, encompassing extra-glandular manifestations, pain, sicca symptoms, fatigue, salivary flow and Schirmer’s tear tests. In addition, rituximab reduced glandular infiltrate and other parameters seen on biopsy.