Alfasigma Reveals Promising Results of Filgotinib in Axial Spondyloarthritis at EULAR 2026
Alfasigma presents first data on filgotinib from the Phase 3 OLINGUITO trial in axial spondyloarthritis at EULAR 2026
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Alfasigma presented positive results from the Phase 3 OLINGUITO trial at EULAR 2026, showing that filgotinib significantly improved symptoms in patients with axial spondyloarthritis. The study demonstrated sustained effects over 52 weeks, with a favorable safety profile, indicating its potential as a new treatment option.
- 01Filgotinib achieved the primary endpoint of ASAS40 response in 39.5% of r-axSpA patients and 34.5% of nr-axSpA patients at week 16, compared to 20.9% and 17.8% in the placebo groups, respectively.
- 0284.6% of r-axSpA and 78.0% of nr-axSpA patients maintained ASAS40 responses at week 52.
- 03Approximately 40-44% of patients reached inactive disease or low disease activity at week 16, increasing to 58-61% at week 52.
- 04No new safety signals were identified over the 52-week period, confirming filgotinib's established safety profile.
- 05The trial involved 495 patients across two studies, focusing on those with inadequate responses to conventional treatments.
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At the EULAR 2026 congress, Alfasigma S.p.A unveiled the first data from the Phase 3 OLINGUITO trial, which evaluated filgotinib, an oral JAK1 preferential inhibitor, in patients with active axial spondyloarthritis (axSpA). The trial demonstrated that filgotinib significantly improved the primary endpoint of ASAS40 at week 16, with 39.5% of patients in the radiographic axSpA group and 34.5% in the non-radiographic group achieving this response, compared to 20.9% and 17.8% in placebo groups, respectively. Notably, improvements were observed as early as week 1 and sustained through 52 weeks, with 84.6% and 78.0% of responders maintaining their improvements. The safety profile remained consistent with previous data, indicating a favorable benefit-risk ratio. The OLINGUITO trial involved 495 patients who had not adequately responded to prior treatments, reinforcing the potential of filgotinib as a viable treatment option for this chronic condition. Alfasigma is currently awaiting regulatory review in Europe for filgotinib as a new treatment for axSpA.
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The results from the OLINGUITO trial may lead to improved treatment options for patients with axial spondyloarthritis, addressing a significant unmet need in this patient population.
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