medwireNews: Phase 3 trial results indicate that abatacept does not have significant clinical efficacy in patients with moderate-to-severe active primary Sjögren’s syndrome (pSS).
The results of this study, involving 60 centers in 13 countries, support those of the single-center ASAP III trial, which demonstrated no significant reduction in disease activity with abatacept versus placebo in a similar patient population.
In the current trial, the adjusted average decrease in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score from baseline to day 169 was not significantly different among the 92 participants who were randomly assigned to receive abatacept 125 mg/week compared with the 95 given placebo, at 3.2 and 3.7 points, respectively. Mean changes in EULAR Sjögren’s Syndrome Patient Reported Index and stimulated whole salivary flow were also comparable in the two groups.
However, despite the lack of clinical benefit, abatacept “had a positive effect on disease-relevant biomarkers, providing evidence of biological activity,” say Alan Baer (Johns Hopkins University School of Medicine, Baltimore, Maryland, USA) and co-investigators. For instance, of 12 disease-relevant biomarkers, there were significant differences in the average change in immunoglobulin (Ig)G, IgA, IgM-RF, kappa light chain, and C4 complement levels between the groups.
“The lack of clinical benefit of abatacept treatment for patients with pSS in the face of an apparent biological effect is not understood,” write the investigators in the Annals of the Rheumatic Diseases.
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