Gilead JAK1 inhibitor Phase 2b/3 clinical results actively provide continuous remission in UC patients.

UC is a chronic long-term disease characterized by inflammation of the mucous membranes of the colon and rectum.
disease, UC has had a significant impact on the quality of life of more than 2 million people worldwide.
despite the treatment available, many patients still experience stool emergencies, incontinence, recurrent episodes of bloody diarrhea, often accompanied by abdominal pain, poor sleep and fatigue.
Filgotinib is a JAK1 selective inhibitor developed jointly by Gilead Sciences and Galapagos.
JAK kinase-dependent cytokines are associated with the pathogenesis of many inflammatory and autoimmune diseases.
this characteristic suggests that JAK inhibitors can be used to treat a variety of inflammatory diseases.
, filgotinib was approved in both the European Union and Japan to treat patients with moderate to severe active rheumatoid arthritis.
Filgotinib molecular structure (Photo: Vaccineist / Public Domain) A total of 1,348 moderately active UC adult patients were randomly treated with filgotinib or a placebo in a randomized double-blind, placebo-controlled Phase 2b/3 clinical trial called SELECTION.
these patients were classified as first-treated patients of biological products and patients treated with biological products based on whether they had previously been treated with biological products.
In patients who had not previously been treated with biologics, the proportion of patients treated with a dose of 200 mg of filgotinib who had achieved clinical remission at the 10th week was significantly higher than in the placebo group (26.1 per cent to 15.3 per cent, p=0.0157).
, the Mayo Clinic Score (MCS) was achieved in patients treated with 200 mg filgotinib compared to placebo (24.5 per cent to 12.4 per cent, p=0.0053), The proportion of endoscopic mitigation (12.2% to 3.6%, p to 0.0047) and histological remission (35.1% to 16.1%, p-lt;0.0001) increased significantly.
among treated patients who had previously been treated with biologics, the proportion of patients treated with 200 mg filgotinib who had achieved clinical remission at the 10th week also increased significantly (11.5 per cent to 4.2 per cent, p=0.0103).
patients who received filgotinib therapy and reached clinical response or remission at week 10 were re-randomly accepted with an induced dose of filgotinib or placebo at a 2:1 scale and treated until week 58 (maintenance trial, n-558).
in week 58, 37.2% of patients treated with 200 mg filgotinib achieved clinical remission, compared with 11.2% of patients treated with placebo.
addition, patients treated with 200 mg filgotinib had significantly higher rates of clinical remission of glucoticoid-free corticosteroids at 58 weeks of 58 weeks (27.2 per cent to 6.4 per cent, p-0.0055).
: s1' Phase 2b/3 Trial Show Efficacy of Filgotinib for Induction and Maintenance of Remision in Moderately and Severely Active Ulcerative Colitis. Retrieved October 12, 2020, from.