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.

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. 

A new descriptive series shows an uncommon association between IgA vasculitis (IgAV) and inflammatory bowel diseases (IBD), with most cases interestingly arising after  or during anti-TNF-α therapy.

Data from 4 parallel case-control studies within The Health Improvement Network looked at risk factors for developing psoriatic arthritis (PsA), psoriasis, rheumatoid arthritis (RA), and ankylosing spondylitis (AS) showed both shared and differentiating risk factors, but statin use was protective in all 4 conditions.

TNFi are frequently used first line in RA patients; and a new analysis shows that repeat use of TNFi dominates over the use of non-TNFi biologics when the initial TNFi therapy has failed. This retrospective analysis of commercial insurance records analyzed the patterns of drug use in adult RA patients who switched to their second biologic or targeted disease-modifying antirheumatic drug.

We have a lot of news, information and approvals to review and discuss, though I need to begin with what's weighing heavily on my mind. After, we'll dive into what we learned this week.

Can an antiinflammatory diet impact axial spondyloarthritis (axSpA)? A 6-month dietary intervention shows that adherence to a Mediterranean diet lowers disease activity in axSpA; but dietary adherence is often incomplete.

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

A prospective study evaluated the value and associations with morning stiffness in patients with clinically suspect arthralgia, and found that the presence of morning stiffness increases the odds of inflammation (as detected by CRP and MRI synovitis).

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.

Another retrospective cohort study has shown that biologic treatment of psoriasis may reduce the subsequent incidence of psoriatic arthritis (PsA).

Today, the U.S.

A current report in Arthritis & Rheumatology examined the Nurses Health Study II data set and shows that parental smoking, and passive exposure to children, can later lead to an increased risk of adult-onset incident seropositive rheumatoid arthritis (RA).

You know, I'm a very good driver. We all think we're great drivers - but consider what it's like to drive in pain: would you be a good driver? Also, I want you to consider the diagnosis of calcium pyrophosphate dihydrate disease (CPPD). But first, let's look at a study out of Scotland, looking at military service and greater risk of hip and knee replacement.

A psoriatic arthritis (PsA) cohort analysis reveals many similarities and few distinctions between those who present with oligoarticular and polyarticular PsA.

A EULAR task force has promulgated several points to consider in managing difficult-to-treat RA. These "points" are unique in directing the rheumatologist's attention to the potential for misdiagnosis and the impact of comorbid conditions on what is perceived as poorly controlled RA.

Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people.

The interleukin-6 inhibitor, tocilizumab (TCZ), was studied in a cohort of difficult systemic sclerosis (SSc)  and was shown to be effective in refractory joint and skin disease with good long-term retention rates and disease stabilization.

A new study in Annals of Rheumatic Disease shows that inflammatory arthritis (IA) may impair male fertility, especially during the peak reproductive age when lower fertility rates, higher childlessness rates and more fertility problems were seen.

The American College of Rheumatology (ACR) is actively engaged with the FDA Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra).