Research company AbbVie announced the filing of an application to FDA and EMA for the registration of a selective reversible inhibitor of JAK kinases of updatetime in the treatment of adult patients with active psoriatic arthritis. In support of registration applications were sent the results of two clinical phase III studies that showed a beneficial effect of the drug on symptoms of the joints.
Clinical studies involving more than 2,000 patients with active form of psoriatic arthritis. In both studies, updatetype was achieved primary endpoint in response to ACR20 criteria at week 12 compared with the placebo group. Updatetime at a dose of 15 mg showed no lesser effectiveness for the ACR20 response, compared with adalimumab at week 12. Patients receiving updatetimer also noted improvement in functional status (according to HAQ-DI) and skin condition (for PASI 75), and most of them achieved minimal disease activity. In General, the safety profile was consistent with previously obtained results in the framework of the phase III program clinical trials of rheumatoid arthritis.
Updatetimer is a selective reversible inhibitor of JAK, the use of which is explored in a number of immune-mediated inflammatory diseases. In August 2019, the FDA approved the drug for the treatment of adult patients with rheumatoid arthritis, moderate and high activity and insufficient response or intolerance to methotrexate. Currently, clinical trials are ongoing phase III for the treatment of psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis.