Preliminary Results of a Double-Blind Randomised Trial of Rituximab Anti-B-Cell Therapy in Patients with Primary Sjogrens Syndrome

Simon Bowman, Colin Everett, Michele Bombardieri, Robert Busch, Paul Emery, Frances Hall, Colin T. Pease, Costantino Pitzalis, Elizabeth Price, Luke Dawson, Peter Smith, Catherine Fernandez, Sharon Ruddock, Linda Sharples, Catherine Reynolds, Sue Pavitt

Research output: Contribution to journalMeeting Abstract


Background/Purpose: Evidence from open-label and observational studies support anti-B-cell therapy in patients with primary Sjogren’s Syndrome (PSS). The TRACTISS trial aimed to determine the extent to which rituximab improves symptoms of fatigue and oral dryness in patients with PSS.

Methods: Multicentre, randomised, parallel group, double-blind, placebo-controlled trial. Patients with PSS, and symptomatic fatigue and oral dryness were recruited from 25 rheumatology clinics in the UK from June 2012 to January 2014. At weeks 0, 2, 24 and 26, patients received pre- and post-infusion corticosteroids and either placebo (P) IV or rituximab (R) IV (1000mg in 250mL). Intervention was decided by 24hr central telephone minimisation service. Primary endpoint was the proportion of patients achieving 30% reduction in either fatigue or oral dryness at 48 weeks, measured by Visual Analogue Scale (VAS). Other outcomes included VAS scales for fatigue or oral dryness separately, global assessment of PSS activity, pain, ocular and overall dryness, as well as salivary and lachrymal flow rates, quality of life, EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) and Patient Reported Index (ESSPRI). Patients and physicians were blinded to the patient’s allocation. ISRCTN 65360827


All patients (n=133) randomised to P (n=66) and to R (n=67) were included in the primary analysis. 55 P and 54 R patients received all 4 infusions in full. Mean age was 54 years, 93% of patients were female, mean ESSDAI was 5.7 and mean time since diagnosis was 5.7 years. Among complete cases at 48 weeks, 21/56 P and 24/61 R patients achieved the primary endpoint. After multiple imputation of missing outcomes, response rates were 36.8% (P) and 39.8% (R) (adjusted odds ratio 1.13, 95% confidence interval 0.50-2.55). There were no significant differences in any outcome measure, except unstimulated salivary flow: P patients deteriorated compared to R patients with a significant relative difference seen after Week 24. There were more adverse events reported in total for R (275 P vs 325 R), but no difference in serious adverse events. (10 vs 10) One serious infusion reaction (R) and one serious anaphylaxis (P) occurred in one patient each.

Conclusion: TRACTISS is the largest randomised trial of biologic therapy in PSS. No improvement in symptoms was seen in the Rituximab arm (unlike the TEARS study) but modest benefit for Rituximab in salivary flow was observed.
Original languageEnglish
Article number11L
Pages (from-to)3955-3957
Number of pages3
JournalArthritis & Rheumatology
Issue numberS10
Publication statusPublished - 2015

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