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…
(Reuters)—AbbVie Inc. and ELi Lilly & Co. are facing fresh delays in the approval of their respective rheumatoid arthritis (RA) drugs for treating the chronic skin disease eczema as the U.S. health regulator assesses the new class of treatment over safety concerns. The treatment, called Janus kinase inhibitors (jakinibs), blocks inflammation-causing enzymes known as Janus…
NIH investigators describe key features and genetic causes of Mendelian interferonopathies, & treatment approaches that may indicate the efficacy of IFN inhibition.
(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…
An observational study found treatment with tofacitinib resulted in only a slightly higher rate of venous thromboembolism than tumor necrosis factor inhibitors in patients with rheumatoid arthritis.
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…
ATLANTA—Encouraging data on interleukin (IL) 23/IL-17 pathway drugs in psoriatic arthritis (PsA), JAK inhibitors in rheumatoid arthritis (RA) treatment and new evidence on physical activity and bone health in women were among the highlights of the 2019 ACR/ARP Annual Meeting’s Clinical Year in Review. Susan Manzi, MD, MPH, director of the Lupus Center for Excellence…
(Reuters)—Eli Lilly & Co said its drug to treat autoimmune disease lupus met the main goal of a mid-stage trial, positioning the drugmaker to begin a bigger study later this year. The data come two weeks after U.S. health regulators approved the drug, baricitinib, under the trade name Olumiant, with a far more restrictive label…
(Reuters)—U.S. drugmaker AbbVie Inc said on Wednesday late-stage data showed its rheumatoid arthritis drug performed better than a placebo in reducing symptoms in moderate-to-severe patients who have not adequately responded to standard treatments. Two doses of the drug, upadacitinib, induced a statistically significant reduction in symptoms compared to a placebo in the 12-week long study,…
Recent clinical trials have shown that baricitinib is safe and effective for treating patients with rheumatoid arthritis who have proved non-responsive to multiple biologic treatments…