Do you know what’s in short supply? Trust, pediatric rheumatologists, and drugs. Since the onset of the pandemic, numerous drug shortages have affected rheumatology, including sulfasalazine, hydroxychloroquine, and now, tocilizumab.

Smartphones and diet; COVID-19 and the numbers - reassuring or not, and what about masks?; and do more drugs mean more switching, less persistence, and patient adherence goes up...or down? All this and more news and journal reports in this week's episode.

In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) shared its perspective on the CY 2022 Medicare Physician Fee Schedule and Quality Payment Program proposed rule. 

 

A retrospective records review of patients with periodic fever syndromes (PFS)  receiving IL-1 inhibitor treatment with canakinumab (CAN), shows CAN to be effective and safe in a variety of PFS patients.

CARRA (Childhood Arthritis and Rheumatology Research Alliance) has compared 3 different treatment strategies for polyarticular JIA to identify the optimal time to biologic regimen.

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.

Following is a statement from ACR President David Karp, MD, PhD, on JAK inhibitors and FDA drug safety communication.

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.

The FDA has again extended its decision on whether the manufacturers of vaping products can market their e-cigarettes in the United States.

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.

Analysis of records from the Mass General Brigham healthcare system in the Boston area, shows that breakthrough infections (after receiving SARS-CoV-2 vaccines) in patients with systemic autoimmune rheumatic diseases (SARDs) are not uncommon, and may be severe or fatal.

 A Mayo Clinic/ Olmsted County study of psoriatic arthritis (PsA) patients has shown that more than half (55%) of PsA patients had a diagnostic delay of > 2 years, and that this delay has not improved over time.

Chronic inflammatory disease (CID) patients are urged to receive the COVID-19 vaccines; but when a cohort of CID patients treated with immunosuppressive medications were given an mRNA-based SARS-CoV-2 vaccination, only those treated with glucocorticoids and B cell depleting therapies (B

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. 

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.