Approximately 50% of young adult patients with childhood-onset rheumatic diseases become lost to follow-up within the first year of transferring to adult rheumatology care, mirroring the statistics of other subspecialties.1,2 One of the challenges cited most consistently by young adult patients and their families relates to differences between rheumatology care delivery in the pediatric and…
On Sept. 1, the U.S. Food & Drug Administration (FDA) announced that it is requiring revisions to the Boxed Warning for the Janus kinase (JAK) inhibitors Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots and death.1 Recommendations for healthcare professionals will include…
Based on data from two phase 3 clinical trials, Health Canada has approved the use of upadacitinib to treat adults with active psoriatic arthritis.
In phase 3 clinical trial, upadacitnib proved superior to placebo and adalimumab in improving the signs and symptoms of RA in patients on stable background methotrexate.
In January, upadacitinib was approved for use in Europe as a 15 mg, once-daily dose to treat patients with psoriatic arthritis and ankylosing spondylitis.
(Reuters Health)—A once-daily 15 mg dose of upadacitinib for rheumatoid arthritis (RA) has similar rates of malignancies, serious infections, major adverse cardiovascular events, and venous thromboembolic events as other Janus kinase inhibitors (jakinibs), results from phase 3 clinical trials suggest. Researchers examined data on treatment emergent adverse events among patients taking upadacitinib in five randomized…
The SELECT-EARLY MTX-controlled trial examined the safety and efficacy of upadacitinib, a potent, reversible jakinib, as monotherapy in patients with moderately to highly active RA and poor prognostic features who are either naive for or have limited exposure to methotrexate.
In August, Abbvie submitted a new drug application for upadacitinib to treat ankylosing spondylitis. And in September, the FDA approved an oral solution of tramadol hydrochloride for pain.
SNOWMASS VILLAGE, COLO.—Janus kinase inhibitors—or Jakinibs—are a relatively new class of disease-modifying anti-rheumatic drugs (DMARDs) that perform well and have a safety profile comparable to biologics. This group of drugs was the subject of The New Frontier: Comparative Safety of JAK Inhibitors, a presentation given at the ACR Winter Symposium by Kevin L. Winthrop, MD,…
ATLANTA—New drug approvals, new and expanded drug indications, and important safety and other updates relevant for rheumatologists were presented by three physicians from the U.S. Food & Drug Administration (FDA) on Nov. 11 at the 2019 ACR/ARP Annual Meeting. New JAK Inhibitor Approved for RA On Aug. 16, 2019, the FDA approved upadacitinib (Rinvoq), an…