Mease and colleagues have catalogued the current practices assessed in the CORRONA registry, noting that increased DMARD switching and decreased time on a given therapy by US physicians.Read Article
Following is a statement from ACR President David Karp, MD, PhD, on JAK inhibitors and FDA drug safety communication.Read Article
This week: high science that affect future treatments; breakthrough infections in our patients, and what's up with that; and soon your radiologist is going to be replaced by AI. This and more in our review of the news and journal articles from the past week.Read Article
Dr. Jack Cush is joined by Drs. Roy Fleischmann (Dallas), Allan Gibofsky (NYC), and Artie Kavanaugh (San Diego) to discuss the 9/2/21 FDA Drug Safety Communication regarding the cardiovascular and cancer risks arising from the Pfizer 1133 (ORAL Surveillance) tofacitinib study, but also applied to baricitinib and upadacitinib.Read Article
Today, Sept.1st, the FDA announced its decision regarding tofacitinib's safety concerns from the Oral Surveillance study - handing down warnings for not only Pfizer's JAK inhibitor, but also for other marketed JAK inhibitors from AbbVie and Eli Lilly & Co.
These safety concerns arise from the Oral Surveillance study - a large, post-marketing, safety trial of tofacitinib versus adalimumab in high risk patients. New warnings about the risks of cardiac events, death and cancer will appear as a revision to the "boxed warnings" in the product label (package insert) for all JAK inhibitors - tofacitinib, baricitinib and upadacitinib.