Dr. Jack Cush reviews the news and FDA proceedings from the past week on RheumNow.com.

Should celecoxib (Celebrex) be officially declared as no riskier for the heart than other non-steroidal anti-inflammatory drugs (NSAIDs) naproxen and ibuprofen, and do those other NSAIDs interfere with aspirin for cardiovascular prevention?

The French Vasculitis Study Group has published the results of the MAINRITSAN2 trial designed to  compare individually tailored versus fixed-schedule rituximab (RTX) reinfusion for remission maintenance in patients with antineutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAVs).

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 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 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.

The PRECISION study took 11 years and 24,081 patients (90% OA; 10% RA).

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.

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.

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.

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.

A recent meeting (April 9-12) of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) considered the problem of dosing errors with methotrexate (MTX), citing "continued reports of overdose." 

CreakyJoints and Pfizer have selected the Mayo Clinic and the University of Alabama at Birmingham (UAB) to each receive a $500K research award (funded by Pfizer Independent Grants) for Learning & Change.

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com. Highlights includes manpower shortfalls, comorbidities in AA Lupus, certolizumab pregnancy safety, which Shingles vaccine is best and the power of combination biologics in severe refractory  SLE.

The current issue of the NEJM reviews the Food and Drug Administration (FDA) “breakthrough therapy” designation that was introduced in 2012 to expedite testing and approval of medications that were intended to treat serious or life-threatening conditions.  This status is granted when prelimi

One of the driving pathogenic mechanisms in systemic lupus erythematosus (SLE) is the generation of immune complexes capable of inducing netosis (NET formation) and NET-derived DNA that may be an amplifying autoantigen and give rise to anti-nuclear autoantibodies (ANAs). 

Apremilast (Otezla) monotherapy was effective for psoriatic arthritis among patients who had not previously received disease-modifying anti-rheumatic drugs (DMARDs) or biologics, a phase III clinical trial funded by the drug's manufacturer found. 

Dr. Maya Buch from Leeds has a thoughtful Viewpoint article in Annals of Rheumatic Disease on how to consider and manage the refractory or difficult rheumatoid arthritis (RA) patient.

Clowse and colleagues have published an extensive review of the certolizumab pegol (CZP) in pregnancy database, and found no evidence that CZP has a teratogenic effect or contributes to fetal harm when compared to the general population. 

The German Autoinflammatory Disease (AID) registry has studied the effects of the IL-6 inhibitor tocilizumab (TCZ) in systemic juvenile idiopathic arthritis (sJIA) patients and shown a clinical response rate of 35% during the first 12 weeks, and inactive disease and/or remission (with medication)