Efficacy

Efficacy of Jyseleca (Filgotinib) in Rheumatoid Arthritis

Jyseleca, with the active ingredient filgotinib, is a selective Janus kinase (JAK) inhibitor used for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Clinical trials have demonstrated that filgotinib effectively reduces the signs and symptoms of RA, improves physical function, and inhibits the progression of structural damage in joints. The efficacy of filgotinib has been shown in a range of patient populations, including those who have not responded adequately to methotrexate or biologic DMARDs.

The FINCH clinical trial program, which includes three pivotal studies (FINCH 1, FINCH 2, and FINCH 3), has provided substantial evidence for the efficacy of filgotinib in RA. In these studies, filgotinib, as monotherapy or in combination with methotrexate or other conventional synthetic DMARDs, achieved significant improvements in American College of Rheumatology criteria (ACR20/50/70) response rates compared to placebo or active comparators. Additionally, filgotinib was associated with a rapid onset of action, with some patients experiencing symptom relief as early as the first week of treatment.

Efficacy of Yuflyma (Adalimumab-aaty) in Rheumatoid Arthritis

Yuflyma, a biosimilar to the reference product Humira (adalimumab), contains the active substance adalimumab-aaty and is indicated for the treatment of adults with moderate-to-severe active rheumatoid arthritis. Adalimumab is a tumor necrosis factor (TNF) inhibitor that works by blocking the action of TNF-alpha, a substance in the body that causes inflammation and is involved in autoimmune diseases like RA. Yuflyma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

The approval of Yuflyma as a biosimilar was based on a comprehensive data package that demonstrated biosimilarity to the reference product, Humira, in terms of safety, efficacy, and immunogenicity. Clinical studies of adalimumab, including those of the reference product, have shown significant improvement in disease activity scores, reduction in the progression of joint damage, and improvement in physical function. As a biosimilar, Yuflyma is expected to produce similar clinical results in RA patients, providing an alternative treatment option with demonstrated efficacy.