BOLOGNA (ITALPRESS) – Alfasigma S.p.A, a global pharmaceutical group, with established skills in rare diseases and specialist therapeutic areas with significant dissatisfied clinical needs, presented 2026 positive results of Phase 3 OLINGUITO clinical study at EULAR Congress. In the study, phylgotinib – oral preferential inhibitor of JAK1 in daily mono-administration, in development for the treatment of adult patients with active axial spondylarthritis (axSpA) – has demonstrated lasting improvements in signs and symptoms of pathology, including the activity of disease and inflammatory processes. The observed safety profile was consistent with the one already known of filgotinib, indicating a favorable benefit-risk relationship in patients with active axSpA. The Olinguito study includes two randomized, double-blind, placebo-controlled international studies (Studio A and Studio B), aimed at assessing efficacy and security of filgotinib 200 mg in daily mono-administration compared to placebo, in patients with axSpA established diagnosis according to ASAS.i classification criteria Patients with confirmed diagnosis of radiographic axSpA (r) (Studio A) or non-radiographical (nr) (Studio B), who showed inadequate response or intolerance to conventional treatments.
In both studies, filgotinib reached the primary endpoint, with a significantly higher percentage of patients who obtained an ASAS40 response per week 16 than the placebo in the r-axSpa study (39.5% versus 20.9%; treatment difference 18.6% [IC 95%: 7,6-29,6]; p=0,001) and nr-axSpA (34,5% versus 17,8%; treatment difference 16,7% [IC 95%: 5,7-27,6]; p=0,003)iii. The ASAS40 filgotinib responses showed early, already from week 1, and continued to increase until week 52. Despite the availability of several therapeutic options, almost half of patients do not respond adequately to the treatments currently available and only 10-20% reach an inactive condition within 16-24 weeks of the start of therapy, according to data of randomized clinical trials with targeted synthetic drugs and DMARDs. iv Phase 3 OLINGUITO data showed that about 40-44% of patients treated with filgotinib reached an inactive disease state (ASDAS-ID) or low disease activity (ASDAS-LDA) per week 16; this percentage increased up to 58-61% per week 52. These results have been observed independently of previous treatments with organic DMARD.
“People living with axial spondyloarthritis can suffer from highly debilitating symptoms since the young age and many patients fail to obtain lasting control of the disease,” said Daniele D’Ambrosio, Alfasigma’s Chief Development Officer. “The primary data of the OLINGUITO study presented at EULAR 2026 showed sustained improvements in the signs and symptoms of axSpA since the first week of treatment with filgotinib, currently being evaluated by the European regulatory authorities as potential new therapeutic option for adults suffering from this chronic and progressive disease.” “Filgotinib has caused a rapid improvement in the symptoms of axSpA; furthermore, the reduction of bone erosion and the minimum or no progression of ankylosis observed during the 52 weeks of study indicate a limited progression of structural damage. These encouraging results support the potential of filgotinib as a therapeutic option for patients with axSpA in all stages of the disease, including those who have already received previous treatments and showed a reduced response to existing therapies,” said Professor Xenofon Baraliakos, Director of the Reumatology department at Rheumazentrum Ruhrgebiet of Herne and Germany Professor of Interna Medicine and Reumatology.
– photo IPA Agency –
(ITALPRESS).
