Efficacy

Efficacy of Jyseleca (Filgotinib) in Rheumatoid Arthritis

Jyseleca, with the active ingredient filgotinib, is a selective Janus kinase (JAK) inhibitor used in the treatment of adults with moderate to severe rheumatoid arthritis (RA). The efficacy of filgotinib for RA was demonstrated in several clinical trials, notably the FINCH series of studies. These trials showed that filgotinib, particularly at a 200 mg dose, significantly reduced the signs and symptoms of RA, improved physical function, and inhibited the progression of structural damage in patients who had an inadequate response to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). It was also found to be effective in patients who had a prior inadequate response to biologic DMARDs.

Patients treated with Jyseleca reported improvements in American College of Rheumatology criteria (ACR20, ACR50, ACR70), which measure the percentage of reduction in disease activity. Additionally, Health Assessment Questionnaire Disability Index (HAQ-DI) scores, which assess physical function, also improved with filgotinib treatment. The onset of action was relatively rapid, with some patients experiencing improvement in symptoms within the first few weeks of treatment.

Efficacy of Simlandi (Adalimumab-ryvk) in Rheumatoid Arthritis

Simlandi, a biosimilar to the reference product adalimumab, is a tumor necrosis factor (TNF) inhibitor indicated for the treatment of multiple inflammatory conditions, including moderate to severe rheumatoid arthritis. Biosimilars are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product. Simlandi has been shown to reduce the signs and symptoms of RA, induce major clinical response, inhibit the progression of structural damage, and improve physical function in adult patients.

The clinical efficacy of Simlandi in rheumatoid arthritis is expected to be similar to that of the reference product, adalimumab, as biosimilars undergo rigorous testing to ensure their efficacy and safety profiles match those of the originator drugs. In clinical studies of adalimumab, patients with RA experienced significant improvements in ACR response criteria and slowed progression of joint damage as seen on X-rays. Furthermore, adalimumab has been shown to improve quality of life and reduce fatigue associated with RA. As a biosimilar, Simlandi is anticipated to offer these therapeutic benefits, providing an alternative option for patients and healthcare providers.