All News
ACR Comments on JAK Inhibitors and FDA Announcement
Following is a statement from ACR President David Karp, MD, PhD, on JAK inhibitors and FDA drug safety communication.
Read Article
FDA Review of Vaping Products Extended
The FDA has again extended its decision on whether the manufacturers of vaping products can market their e-cigarettes in the United States.
Read Article
Lymphoma in RA: Disease Activity Matters
Among patients with rheumatoid arthritis (RA), the strongest risk factors for the development of lymphoma were disease activity and severity, French researchers found.
In a multivariate analysis, having a high Disease Activity Score in 28 joints (DAS28) at baseline conferred twice the risk for lymphoma, with an odds ratio of 2.09 (95% CI 1.41-3.38), according to Gaetane Nocturne, MD, of Hôpital Bicêtre in Ile-de-France, and colleagues.
Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors
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
FDA: New Cardiac and Cancer Warnings for All JAK Inhibitors
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.
ACR Guidance on Timing of 3rd Dose Booster with Immunomodulatory Drugs
The American College of Rheumatology has issued an updated version of its COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases following recent recommendations from the CDC that certain immunocompromised patients receive a third dose of an availabl
Read Article
Rheumatic Events With Checkpoint Inhibitors: Tumor Type Matters
Among the factors that were associated with an increased risk for the development of rheumatic immune-related adverse events following cancer treatment with immune checkpoint inhibitors (ICIs) was the type of malignancy involved, a large case-control study found.
Read Article
Skin Involvement with HMGCR Necrotizing Myositis
The Journal of Autoimmunity reports that anti-HMRCR antibody positive, necrotizing myositis patients frequently have cutaneous lesions, moreso than previously reported.
Read Article
No Cancer Risk with TNF Inhibitors in Rheumatoid Arthritis
The ARTIS Study Group has published their analysis of (non-skin) cancer risk in rheumatoid arthritis, claiming the overall safety of biologic DMARDs and targeted synthetic DMARDs (tsDMARDs).
Read Article
Arthritis as a Harbinger of Pediatric Cancer
Lancet Rheumatology has published a cohort analysis showing that a small but significant subset of children presenting with arthralgia or arthritis may have a pediatric malignancy.
Read Article
ICYMI: RheumNow Podcast – Tofacitinib Safety Concerns
Dr. Jack Cush reviews and discusses the news and journal reports from the past week on RheumNow.com.
Read Article
ICYMI: JAK Inhibitor Misses Endpoint in Safety Study. Now What?
Pfizer announced results Wednesday from its FDA-mandated postmarketing safety study of tofacitinib (Xeljanz), and they don't bode well for the drug and possibly others in its class.
Read Article
RheumNow Podcast – Modern Treatment of RA Pregnancy (6.25.2021)
Dr. Jack Cush reviews this week’s news and journal reports featured on RheumNow.com.
Read Article
Links:
Jeffrey Sparks MD MMSc jeffsparks ( View Tweet)
Links:
Links:
Dr. John Cush RheumNow ( View Tweet)
Links:
Links:
Dr. John Cush RheumNow ( View Tweet)
