Tuesday, 16 Jul 2019

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Nintedanib May Benefit Systemic Sclerosis Related Interstitial Lung Disease

The NEJM reports a randomized placebo controlled trial of nintedanib, a tyrosine kinase inhibitor, in systemic sclerosis patients with interstitial lung disease (ILD) resulted in less pulmonary decline, but had no effect on other features of systemic sclerosis. 

Steroids, Not Biologics, Drive Arthroplasty Infections in RA

Medicare and Truven MarketScan administrative data study (2006 through 2015) of rheumatoid arthritis (RA) undergoing arthroplasty found that while that the risks of perioperative infection was similar across biologics, the infection risk with glucocorticoid use, especially at > 10 mg/d, was significantly greater.

EMA Restricts Tofacitinib Dosing

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency issued recommendations limiting the use of Xeljanz (tofacitinib) 10 mg twice daily in patients with ulcerative colitis in the EU. The new recommendations are temporary while PRAC undertakes a review of all available evidence on the safety and efficacy of tofacitinib. The review follows warnings of an increased risk of pulmonary embolism (PE) and death from the U.S. Food and Drug Administration based on Pfizer's large post-marketing safety study (in high risk rheumatoid arthritis patients with one or more underlying cardiovascular risk factors) wherein those receiving in tofacitinib 10 mg twice daily in study A3921133 had more PE and mortalities than comparator groups (tofacitinib 5 mg bid or adalimumab).

Opioids, SSRIs and Steroids Increase Fracture Risk in RA

Analysis of a large US observational rheumatoid arthritis (RA) patients finds that opioids, SSRIs and glucocorticoids were associated with increased risk of fracture in RA, whereas statins and TNFi had a decreased vertebral fracture risk.

RheumNow Podcast – Richer or Poorer (5.17.19)

Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com

Coexistent Gout Increases Risk in Rheumatoid Arthritis

It his often said that gout and rheumatoid arthritis (RA) cannot coexist and where confusion exists, a good history and testing for serum urate (SUA) and rheumatoid factor (RF) can usually clarify the dominant disorders. A recent study shows that hyperuricemia and gout are uncommon in RA, but when present shows an increased risk of comorbidities and cardiovascular (CV) mortality.

Risk Score Predicts Thrombosis Recurrence in APS

A combination risk score helped predict recurrent thrombosis -- particularly arterial -- among patients with antiphospholipid syndrome (APS), an international study found.

FDA Final Guidance on Interchangeability with Biosimilars

The FDA has published an industry guidance document to define interchangeability as regards to biosimilar use in the United States under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). 

Less Structural Damage with T2T in Gout

A two‐year randomized clinical trial has demonstrated that allopurinol dose escalation to a target serum urate (SU) results in less bone erosion, structural damage and urate crystal deposition in patients with gout.

Methotrexate Use Not Linked to Interstitial Lung Disease in RA

People with rheumatoid arthritis have a significant risk of developing interstitial lung disease (RA-ILD), yet there is often a question as to whether methotrexate (MTX) exposure can cause or worsen ILD.  A controlled cohort study suggests that MTX use is not associated with an increased risk of RA-ILD and instead, there is evidence suggesting MTX use may delay the onset of ILD.

Racial Disparities in Mortality Associated with Systemic Lupus Erythematosus

A Morbidity and Mortality Weekly Report on a registry of systemic lupus erythematosus (SLE) patients from two Georgia counties (Fulton and Dekalb) shows SLE mortality was 2-3 times higher compared to the general population, especially amongst blacks; notably deaths occurred sooner after diagnosis and at a mean age approximately 13 years younger.

Generic Price Fixing Alleged by State Prosecutors

The NY Times and 60 Minutes have reported that Connecticut, along with 43 other states, filed a mega-lawsuit accusing the generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars. (Citation source: https://buff.ly/2vSmv03)