A majority of state legislatures have concluded their work for 2016. The ACR’s state advocacy efforts continued to focus on policy benefiting rheumatologists and patients alike. The two dominant issues this year were biosimilar substitution and step therapy. Biosimilar Substitution Biosimilar substitution remains the most prevalent issue throughout the states. The ACR continues to monitor…

New Assays May Help in the Diagnosis & Management of Antiphospholipid Syndrome
A new study found that measuring the presence of additional antibodies specific for Domain I (aDI) of β2-glycoprotein (β2GPI) may improve the diagnosis of antiphospholipid syndrome. Based on their findings, researchers conclude that aDI tests may be a useful addition to, but not a replacement for, standard aβ2GPI tests…
Valeant Psoriasis Drug’s Suicide Risk Hard to Assess, Say FDA Staff
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday. The review comes two days ahead of a meeting of outside experts who will advise the FDA on…

Patients with PsA, Cutaneous Psoriasis May Undergo Hip Replacement
A recent study of patients with psoriatic arthritis and cutaneous psoriasis found that these patients do not have a higher risk of worse outcomes after total hip arthroplasty compared with patients with osteoarthritis…

Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting
In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…
FDA Panel Supports Novartis Biosimilar of Etanercept
(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…
FDA Panel Backs Amgen Biosimilar of Humira
(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…

Dysbiosis of Gut, But Not Ocular Microbiome, Associated with Sjögren’s Syndrome
Research has explored the connection between Sjögren’s syndrome and intestinal dysbiosis associated with ocular mucosal disease. A recent study found that oral antibiotics and desiccating stress lead to extreme changes in the gut microbiota in mice. In patients with Sjögren’s syndrome, researchers found that patients with the most severe keratoconjunctivitis sicca and combined systemic and ocular disease had the lowest diversity of stool microbiota…
Prescription-Drug Monitoring Saves Lives, Could Save More
(Reuters Health)—State programs that monitor narcotic prescriptions help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day, a new study finds. States with the most robust programs—ones that tracked a greater number of potentially addictive medications and updated their databases at least weekly—saw the biggest drops…
U.S. Justice Department Has Concerns about Aetna-Humana Deal
(Reuters)—The U.S. Department of Justice has significant concerns about Aetna Inc.’s proposed acquisition of health insurer Humana Inc., a source familiar with the situation said on Thursday, and shares of Humana fell more than 11%. Aetna’s purchase of Humana would combine two of the largest providers of Medicare Advantage plans for elderly people, and investors…
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