Filgotinib safe and effective in patients with different forms of axSpA: trial

Filgotinib, a candidate oral therapy for adults with active axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS), alleviated symptoms and demonstrated a favorable safety profile in a Phase 3 clinical trial. The trial, called OLINGUITO (NCT05785611), includes two parallel studies: one involving patients with radioactive axSpA (r-axSpA), also known as AS, and the other involving participants with nonradioactive axSpA (nr-axSpA). In both studies, the primary goal of the International Spondyloarthritis Assessment Scale (ASAS) was achieved at least 40% after 16 weeks of treatment.

These positive OLINGUITO top-line results demonstrate the potential of filgotinib to address this critical unmet need in patients with axial spondyloarthritis. Filgotinib is currently approved for use in certain patients with rheumatoid arthritisor ulcerative colitis in the European Union (EU), the United Kingdom, and other countries. It is sold under the brand nameJyseleca. Application for expanded approval of axSpA based on data from OLINGUITO.

Based on these encouraging results, Clinical intends to apply to extend the current indication for filgotinib, providing a potential new treatment option for patients with axial spondyloarthritis, who often experience debilitating symptoms since childhood.

AxSpA is a type of arthritis that primarily affects the joints in the spine, causing pain, stiffness and other symptoms. Patients are diagnosed with r-axSpA when X-rays show joint damage. nr-axSpA is diagnosed when symptoms are consistent with axSpA but there is no visible joint damage on X-rays. As with other types of arthritis, inflammation is a key process in axSpA. Filgotinib is designed to block Janus kinase 1, a protein involved in inflammation. Alfasigma expects the therapy to reduce inflammation in a variety of conditions, including axSpA.

InOLINGUITO, participants were randomly assigned to receive 200 mg of filgotinib or placebo once daily for 16 weeks, approximately four months. A total of 495 people took part in the trial, 258 with r-axSpA and 237 with nr-axSpA. At the end of this period, researchers assessed changes in ASAS scores, which include global patient assessment domains, as well as measures of pain, function and inflammation. The primary objective of the trial is to assess the proportion of patients who achieve ASAS40, meaning a 40% improvement in at least three of four areas after 16 weeks of treatment, without any score worsening.

In parallel studies of each trial, patients who received filgotinibBoth r-axSpA and nr-axSpA patients achieved this goal. The therapy's safety profile was consistent with 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 with axSpA at all stages of the disease. The disease burden in these patients remains high due to limited treatment options. It is therefore encouraging that the primary endpoints for the axSpA indication were met in dedicated studies.

After the initial 16 weeks, participants without certain health risks were eligible to enter the open-label treatment period, in which they took 200 mg of filgotinib daily for 52 weeks, about a year. All participants completed the 52nd week of follow-up in May.

Next, researchers will select participants who demonstrate sustained low disease activity or inactive disease during open-label treatment. They will randomly assign these people to take 100 or 200 mg of filgotinib daily for the next 52 weeks. Those taking a lower dose may choose to increase to a higher dose during an episode of symptoms. Selected participants will then move on to an open-label extension study, collecting approximately 2.5 years of long-term safety and efficacy data.

References:https://ankylosingspondylitisnews.com/2025/08/11/filgotinib-safe-effective-patients-different-axspa-forms-trial/