Filgotinib safe, effective in patients with different forms of axSpA: Trial
Developer Alfasigma plans to apply for expanded approval in EU, UK
Filgotinib, Alfasigma’s candidate oral therapy for adults with active axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS), eased symptoms and showed a favorable safety profile in a Phase 3 clinical trial.
The trial, called OLINGUITO (NCT05785611), comprised two parallel studies: one involving patients with radiographic axSpA (r-axSpA), also known as AS, and another involving participants with non-radiographic axSpA (nr-axSpA). In both studies, the main goal of achieving at least a 40% improvement on the Assessment of Spondyloarthritis International Society scale (ASAS) after 16 weeks of treatment was met.
“These positive OLINGUITO topline results demonstrate filgotinib’s potential to address this critical unmet need for patients with axial spondyloarthritis,” Daniele D’Ambrosio, MD, PhD, chief development officer at Alfasigma, said in a company press release.
Filgotinib is currently approved in the European Union (EU), U.K., and other countries for certain people with rheumatoid arthritis or ulcerative colitis. It’s marketed under the brand name Jyseleca. Alfasigma now plans to submit an application to EU and U.K. regulators to petition for the therapy’s expanded approval for axSpA based on data from OLINGUITO. The company acquired the therapy’s rights from its original developer, Galápagos, in 2024.
“Based on these encouraging results, we intend to submit for an extension of filgotinib’s current indications, offering a potential new treatment option for patients with axial spondyloarthritis who often struggle with debilitating symptoms from a young age,” D’Ambrosio said.
Goal met in each of trial’s parallel studies
AxSpA is a type of arthritis that primarily affects the joints of the spine, leading to pain, stiffness, and other symptoms. When joint damage is visible on X-rays, patients are diagnosed with r-axSpA. A diagnosis of nr-axSpA may be made when symptoms are consistent with axSpA, but there is no visible joint damage on X-rays.
As in other types of arthritis, inflammation is a key process in axSpA. Filgotinib aims to block Janus kinase 1, a protein involved in inflammation. Alfasigma expects the therapy to be able to ease inflammation in several conditions, including axSpA.
In OLINGUITO, participants were randomly assigned to receive either 200 mg of filgotinib or a placebo once daily for 16 weeks, or about four months. A total of 495 individuals participated in the trial, including 258 with r-axSpA and 237 with nr-axSpA.
At the end of this period, investigators assessed changes in the ASAS score, which includes a patient global assessment domain, as well as metrics for pain, function, and inflammation. The trial’s main goal was to assess the proportion of patients achieving ASAS40, meaning a 40% improvement in at least three of the four domains without worsening of any scores, after 16 weeks of treatment.
This goal was met by patients with r-axSpA and nr-axSpA treated with filgotinib in each of the trial’s parallel studies, according to the company.
Filgotinib focus of extension study
The therapy’s safety profile was consistent with that of previous studies, with no unexpected events reported.
“These results from the OLINGUITO Phase 3 clinical trial clearly support the potential of filgotinib as a treatment option for patients living with axSpA at all stages of the disease,” said Xenofon Baraliakos, MD, PhD, the head of rheumatology at the Rheumazentrum Ruhrgebiet in Herne, Germany. “The burden of disease for these patients remains high as treatment options are limited. It is therefore encouraging that the primary endpoint for both axSpA indications was met in dedicated studies.”
After the initial 16-week period, participants who didn’t have certain health risks were eligible to enter an open-label treatment period, where they received filgotinib at a daily dose of 200 mg for a total of 52 weeks, or about a year. All participants completed their week 52 follow-up visit in May.
These results from the OLINGUITO Phase 3 clinical trial clearly support the potential of filgotinib as a treatment option for patients living with axSpA at all stages of the disease.
Next, investigators will select participants who showed sustained low disease activity or inactive disease during the open-label treatment period. They will randomly assign these individuals to receive either 100 or 200 mg daily doses of filgotinib for another 52 weeks. Those on the lower dose will have the option to bump up to the higher dose during symptom flares. Select participants will then continue in an open-label extension study to gather long-term safety and efficacy data for approximately 2.5 years.
Alfasigma plans to disclose further details in future scientific conferences and peer-reviewed journals.
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