(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…
RA Patients Taking Either 15 mg or 30 mg Dose of Upadacitinib Experience Improvement
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.
FDA Receives Upadacitinib Application for Ankylosing Spondylitis & Approves Tramadol Hydrochloride Oral Solution
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.
Researchers Give Update on Janus Kinase (JAK) Inhibitors
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,…
FDA Update: New Drug Approvals, New & Expanded Indications, & More
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…
Canada & E.U. Approve Upadacitinib for RA
Upadacitinib will soon be available to treat patients with moderate to severe rheumatoid arthritis in Canada and the E.U…
Rituximab-abbs Available in the U.S.; Plus Upadacitinib in Phase 3 Trials for PsA
Rituximab-abbs, which is biosimilar to rituximab, is now available in the U.S. to treat specific cancers…
New Options for Treatment-Resistant RA
Two JAK inhibitors, one recently approved by the FDA, have shown improvements in patients with active RA for whom other therapies have proved ineffective…
FDA Approves Upadacitinib for RA
Results from multiple phase 3 clinical trails have led to the FDA approval of upadacitinib to treat patients with moderate to severe active RA…
FDA Approves AbbVie’s New Rheumatoid Arthritis Drug
(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…