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An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff  |  

(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…

Ethics Forum: Unexpected Ethical Issues in Private Practice, Clinical Research

Donah Zack Crawford, MA, Jill Johnson, MD, Neal K. Moskowitz, MD, PhD, & James Udell, MD  |  

Ethical issues that arise in the average rheumatology practice and in clinical research are often straightforward. The AMA Code of Medical Ethics and the Office Practice and Procedures Manual offer useful information.1 In research, the Protocol and Investigators Agreement spells out who you can enroll and how the trial must be conducted. But still—even when…

How HLA-B27 Research Landmarks, Advances Relate to Ankylosing Spondylitis Pathogenesis

How HLA-B27 Research Landmarks, Advances Relate to Ankylosing Spondylitis Pathogenesis

Joerg Ermann, MD  |  

The mechanistic link between human leukocyte antigen B27 (HLA-B27) and ankylosing spondylitis (AS) is one of the great enigmas in rheumatology. The introduction of biological therapies that target tumor necrosis factor (TNF) or the interleukin (IL) 23/IL-17A axis has had a major impact on the quality of life for many patients with AS, and one…

FDA Panel Backs Amgen Biosimilar of Humira

Toni Clarke  |  

(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…

Exercise Therapy Recommended to Manage Knee Osteoarthritis

Allyn Bove, PT, DPT, & G. Kelley Fitzgerald, PT, PhD, FAPTA  |  

The benefits of exercise therapy for individuals with knee osteoarthritis (OA) are well known. The ACR strongly recommends both aquatic exercise and land-based aerobic and resistance exercise for managing knee OA.1 A recent Cochrane systematic review and meta-analysis concluded that high-quality evidence supports the use of exercise to reduce pain and improve physical function and…

Rheumatology Drug Updates: Labeling for Fluoroquinolones; FDA to Review Benzhydrocodone/Acetaminophen Combination

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FDA Restricts Fluoroquinolone Use The U.S. Food and Drug Administration (FDA) has twice previously communicated safety information about systemic fluoroquinolones—in August 2013 and July 2008. The safety issues of this medication class described in its latest Drug Safety Communication were also discussed at a November 2015 FDA Advisory Committee meeting.1 The FDA is now advising…

Rheumatologists on the Move, July 2016

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HSS Holds First Rheumatology Gala The Hospital for Special Surgery (HSS) in New York City hosted a Rheumatology Gala in May. The event, held at The Park Avenue Armory in Manhattan, was held to increase awareness of HSS’s leading research and treatment of rheumatic diseases—particularly with “high-net worth people,” according to former ACR President Mary…