This article is more than 5 years old. Information may no longer be current.
Rituximab seen as not effective for symptoms of Sjögren’s Syndrome
Click Here to Manage Email Alerts
Rituximab was not effective for relief of symptomatic fatigue and oral dryness in patients with Sjögren’s Syndrome, according to a recently published analysis.
“Although there did not appear to be any excess risk due to rituximab, the results of the TRACTISS trial do not support the general use of rituximab in treating [primary Sjögren’s Syndrome] PSS, particularly in patients with recent disease onset and low disease activity,” Simon J. Bowman, PhD, FRCP, from University Hospitals Birmingham NHS Foundation Trust, and colleagues wrote. “Meta-analysis with the TEARS study may improve overall precision of findings, but it seems unlikely that the combined results will identify a worthwhile treatment benefit.”
Researchers performed a randomized controlled trial of 133 patients diagnosed with PSS in the United Kingdom between 2011 and 2014. Patients were randomized to receive either intravenous placebo or rituximab at weeks 0, 2, 24 and 26. The primary endpoint was the percentage of patients who achieved a 30% reduction in either fatigue or oral dryness, as determined by VAS, after 48 weeks.
Investigators found 21 of 56 patients on placebo and 24 of 61 patients on rituximab achieved the primary endpoint. The rituximab response rate was 39.8% compared with 36.8% for placebo, with no significant risk for reduction of VAS in rituximab. Furthermore, there were no significant improvements in secondary outcomes, except for unstimulated salivary flow. The rituximab group also had more adverse events; however, there was no difference in serious adverse events, as each group had 10. The average costs were £10,752 for rituximab and £2,672 for placebo.
“The need for further larger randomized trials to demonstrate longer-term benefit appears questionable, since the lack of effect of two courses of rituximab seems in line with the lack of benefit of one course in randomized trials,” the researchers wrote. “Rituximab may still have a role in treating PSS patients with high levels of systemic disease activity who have failed to improve following conventional immunosuppressive therapy.” – by Will A. Offit
Disclosure: Researchers report funding by Arthritis Research UK.
Click Here to Manage Email Alerts