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ACR Statement on CMS Medicare Advantage Final Rule
In August 2018, the CMS announced that Medicare Advantage (MA) plans would be allowed to utilize step therapy for Part B drugs. The American College of Rheumatology (ACR) expressed strong concerns about this proposal.
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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).
RheumNow Podcast – Richer or Poorer (5.17.19)
Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com
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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.
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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)).
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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.
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Low Serious Infection Risk with Newer Agents in Psoriasis
JAMA Dermatology reports on a comparative cohort study of 107,707 psoriasis patients, finding a decreased risk of serious infections among users of apremilast, etanercept, and ustekinumab when compared with methotrexate.
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RheumNow Podcast – Periodontitis in RA Relatives (5.10.19)
Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com
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Gabapentinoid Drugs Overuse and Misuse
A recent article in JAMA by Drs. Goodman and Brett reviews the increasing off label use of gabapentinoid drugs, originally developed as antiseizure drugs that are now increasingly prescribed for painful conditions.
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Drug Pricing Regulations in US and Canada
Reuters reports on regulatory efforts by Canada and the US to curb the rising cost of drugs, especially expensive new medicines.
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Denosumab Protects Against RA Erosions
Combining denosumab (Prolia) with a conventional disease-modifying antirheumatic drug (DMARD) such as methotrexate showed promise for slowing radiographic damage in rheumatoid arthritis (RA), a manufacturer-sponsored phase III trial called DESIRABLE found.
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CDC: One in Four US Adults have Arthritis
MMWR reports that in 2017, one in four US adults have arthritis (range from 22.8% to 34.6%), with higher rates in Appalachia and Lower Mississippi Valley regions. Of those with arthritis, 31% reported to have "severe arthritis".
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RheumNow Podcast – DESIREABLE Results (5.3.19)
Dr. Jack Cush reviews the latest journal articles and rheumatology news from the past week on RheumNow.com:
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Nonadherence is Costly for Patients in Pain
A comparative cohort study of patients with osteoarthritis (OA), gout, diabetic peripheral neuropathy (pDPN), post-herpetic neuralgia (PHN), and fibromyalgia (FM) shows that nonadherence to pain medications is high and leads to greater overall health care resource utilization and costs.
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New ACR/AF Guidelines on JIA Polyarthritis and Uveitis
The American College of Rheumatology (ACR) and the Arthritis Foundation (AF) have released two guidelines on management of juvenile idiopathic arthritis (JIA).
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Targeting GM-CSF Works in Rheumatoid Arthritis
Namilumab, a monoclonal antibody that targets the granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand, showed promise as a treatment for rheumatoid arthritis (RA) in a phase II study.
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More Studies Needed to Optimize the Use of Osteoporosis Drugs
The Annals of Internal Medicine reports a metanalysis done to examine the optimal length of long-term osteoporosis drug treatment (ODT) and whether harms are associated with long-term ODT and while the ODT benefits are clear, the risk of rare harms and need for drug holidays is less certain. 
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Skyrizi (risankizumab) FDA Approved for Psoriasis
AbbVie has announced that the US FDA has granted the approval of Skyrizi (risankizumab-rzaa) for the treatment of moderate to severe plaque psoriasis.
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Ustekinumab Effective in Behcet's Disease
A small prospective study has shown that ustekinumab is safe and effective in Behçet's disease (BD) with recurrent oral ulcers (OU).
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NIH Workshop on Unmet Needs in Osteoporosis
In October 2018, the National Institutes of Health (NIH) convened a workshop to address the "Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention"
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