Friday, 25 May 2018

News

FDA Arthritis Panel Split on the Efficacy and Safety of Baricitinib in RA

On Monday, April 23rd the FDA convened the Arthritis Advisory Committee (AAC) to evaluate Lilly’s resubmitted NDA for the approval of the JAK inhibitor baricitinib for use in rheumatoid arthritis (RA). The panel included 15 voting members that included 7 rheumatologists, 3 epidemiologist-statisticians, a hematologist, 2 patient representatives and 2 pharmacologists.

Lupus Subgroup Responds to Anti-CD22

The monoclonal antibody epratuzumab showed promise as a B-cell depleting agent in patients with concomitant systemic lupus erythematosus (SLE) and Sjogren's syndrome, a post-hoc analysis of two phase III trials found.

FDA Review: Take Two for Baricitinib

FDA staff remain worried about the safety of baricitinib, an oral JAK inhibitor intended for treatment of rheumatoid arthritis, according to briefing documents prepared for an advisory committee meeting on Monday.

Will Aspirin Cotherapy Undermine Celecoxib’s Safety Effects?

The PRECISION study took 11 years and 24,081 patients (90% OA; 10% RA). It showed that celecoxib had fewer gastrointestinal events, fewer renal events and less ATPC cardiac events compared to ibuprofen - with an 18% reduction in major CV events and a 32% reduction in all-cause mortaility compared to ibuprofen.

The RheumNow Week in Review – Vitamin D Snark Report (4.20.18)

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com.  A second life for Syk kinase, Vitamin D talk, VTE, regulatory hearings and the Lupus clinic edge.

Wear Your Pajamas to Work for Lupus

I suspect that everyone in rheumatology has a special place in their hearts for lupus patients. Their disease is so cruel, and we have so little to offer them, but the young women (and some men) that I treat keep battling on. The longer I have cared for them, the more I wanted to do for them. Managing their illness alone did not seem like enough. 

Tobacco Associated Deaths in the USA

JAMA Internal Medicine reports that in the USA, those who smoke cigar, pipe, or cigarette have a significant overall  mortality risk, and a much highers cancer mortality risk compared to nonsmokers.

The National Longitudinal Mortality Study collected baseline survey data from 1985 through 2011 and included 357,420 participants reporting on their use of cigar, pipes, or cigarettes.

Shared Epitope - Smoking Pathogenic Link Clarified

Proceedings of the National Academy of Sciences (PNAS) has published new research on the mechanistic link between the rheumatoid arthritis (RA) "shared epitope" (SE) risk alleles and environmental triggers such as cigarette smoke that leads to joint inflammation and bony destruction. 

NSAIDs and Acetaminophen Preferred Over Opioids for Dental Pain

A systematic review in the Journal of the American Dental Association evaluated the safety and efficacy of analgesics and foundp opioids less effective than nonsteroidal anti-inflammatory drugs (NSAIDs) alone or in combination with acetaminophen when treating dental pain.

USPSTF Recommendations on Vitamin D, Calcium Supplementation to Prevent Fractures

The U.S. Preventive Services Task Force (USPSTF) concludes current scientific evidence is insufficient regarding the use of vitamin D and calcium, alone or in combination, to prevent fractures in men and premenopausal women. The USPSTF recommends against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium to prevent fractures in postmenopausal women. Current scientific evidence is insufficient regarding the use of vitamin D and calcium at doses greater than 400 IU of vitamin D and greater than 1,000 mg of calcium in postmenopausal women.

Kineret Approved for Still's Disease in EU

SOBI has announced that Kineret (anakinra) has been approved by the European Commission (EC) for the treatment of Still’s disease (Systemic Juvenile Idiopathic Arthritis [SJIA] and Adult-Onset Still’s Disease [AOSD]), in all 28 European Union (EU) member states. Still's disease is a rare systemic multi-organ disorder of auto-inflammatory nature that affects approximately 25,000 children and adults in the EU.

MMWR: Cannabis Use in the Colorado Workers

MMWR reports that eight states, including Colorado, have legalized recreational marijuana for use by adults and that a study of use in Colorado has shown that nearly 15% of Colorado adult workers have used marijuana in the past 30 days. Use was highest among young adults, especially men, working in the Accommodation/Food Services and Food Preparation/Serving industries.