I try to keep my research-oriented posts focussed on positive news, but occasionally some bad news pops up that needs to be shared.
Rituxan (generic Rituximab) is a biologic monoclonal antibody used to treat rheumatoid arthritis and various cancers. As a B-cell depletion therapy, it was seen as a promising treatment for B-cell diseases like lupus and Sjogren’s Syndrome. Early studies on recently diagnosed SS patients showed promising results, but a conflicting study in 2014 showed no improvement. These were small studies, however, and it wasn’t clear what could be trusted. Many eyes (including mine) were fixed on the TRACTISS study, a UK double-blind randomized study with 133 participants over several years.
I missed the posting many months ago, but it seems that preliminary results from the TRACTISS study are in, and they aren’t positive:
“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.”
The only improvement found was a minor uptick in unstimulated salivary flow. The ESSDAI score (SS Disease Activity Index), which measures total disease activity, including fatigue, was statistically the same for both the treatment and placebo arms.
A trial was recently listed for dual treatment with Rituxan and Benlysta. GlaxoSmithKline is the maker of Benlysta, which has shown positive results in a phase 2 SS trial. Perhaps this will be the winning combination for SS patients, but for now, it’s one step back.