According to a German study presented during ACR Convergence 2021, treatment persistence with JAK inhibitors is comparable to TNF inhibitors and other bDMARDs among patients with rheumatoid arthritis.
FDA Discussed 2021 Drug Warnings & Approvals at ACR Annual Meeting
ACR Convergence 2021—The recent Boxed Warning requirement applied to three Janus kinase (JAK) inhibitors, cautioning doctors and patients about several major risks in patients with rheumatoid arthritis, came only after rigorous data collection and careful consideration of the risks and the benefits, U.S. Food & Drug Administration (FDA) officials said in November at ACR Convergence…
Clinical Rheumatology Year in Review 2021
ACR Convergence 2021—On Nov. 5, Karen H. Costenbader, MD, MPH, professor of medicine, Harvard Medical School, and director of the lupus program, Brigham and Women’s Hospital, Boston, gave a whirlwind review of the most important clinical rheumatology publications of the past year. Testing New Medications for Rheumatic Disease ADVOCATE Trial of Avacopan Dr. Costenbader first…
FDA Requires New Boxed Warnings on JAK Inhibitors, Places Restrictions on Use
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…
AbbVie, Lilly Face New Delays in FDA Approval for Expanded Use of Janus Kinase Inhibitors
(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…
Interfering with Interferon: Experts Discuss IFN Signaling & IFN Inhibition Treatment Possibilities
NIH investigators describe key features and genetic causes of Mendelian interferonopathies, & treatment approaches that may indicate the efficacy of IFN inhibition.
Upadacitinib Safety Similar to Other Jakinibs for RA
(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…
Janus Kinase vs. TNF Inhibitors: The Context for Venous Thromboembolism Risk with RA Treatments
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.
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…
Year in Review: Rheumatic Disease Research in 2019
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…