IL-6 ‘not a relevant therapeutic target’ in primary Sjögren’s syndrome
medwireNews: Treatment with the interleukin (IL)-6 receptor inhibitor tocilizumab does not improve clinical outcomes for patients with primary Sjögren’s syndrome (pSS), suggest findings from the ETAP trial.
The phase 2/3 study included 110 patients with pSS and a EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score of at least 5 points who were randomly assigned to receive six once-monthly infusions of tocilizumab 8 mg/kg or placebo.
Jacques-Eric Gottenberg (Hôpital de Hautepierre, Strasbourg, France) and co-investigators report that rates of treatment response at week 24 – defined as a decrease in ESSDAI of 3 points or more, no occurrence of moderate or severe activity in any new ESSDAI domain, and no worsening in physician global assessment – did not significantly differ in the tocilizumab and placebo arms, at 52.7% and 63.6%, respectively. There were also no significant between-group differences in patient-reported and immunologic outcomes.
“Altogether, these negative results […] indicate that IL-6 does not represent a relevant therapeutic target in pSS,” write Gottenberg and team in the Annals of the Rheumatic Diseases.
They note that clinical efficacy of tocilizumab “is usually observed rapidly, within a few weeks of treatment” in patients with rheumatoid arthritis or giant cell arteritis, and “[t]herefore, a longer-term evaluation of the primary endpoint (after 6 months) would not have changed the overall results.”
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