(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…
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FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira
(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…
Periodontal Infection May Determine Best Treatment for Patients with RA
Past research has indicated that a periodontal pathogen that produces the peptidularginine deiminase (PPAD) enzyme may affect levels of anti-cyclic citrullinated peptide antibody. A new study suggests serum anti-PPAD IgG titers might be a useful biomarker for designing a personalized treatment strategy for RA…
Immunotherapy Largely Untested in Patients with Autoimmune Disease
(Reuters Health)—The safety and effectiveness of cancer immunotherapy is largely unknown in patients with autoimmune diseases, researchers say—and that might account for up to a quarter of individuals with lung cancer. Patients with autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis or psoriasis, have been mostly excluded from clinical trials testing immunotherapies over fears that…
Samsung Bioepis Receives Final European Approval for Its Remicade Copy
SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar…
Rheumatology Drug Updates: Infliximab Biosimilar Gets FDA Approval & More
April 5, 2016, marks a revolutionary day in the treatment of autoimmune diseases: The U.S. Food and Drug Administration (FDA) approved an infliximab (Remicade) biosimilar, known as Inflectra (infliximab-dyyb). Infliximab-dyyb, which is administered by intravenous infusion, is the first biosimilar drug approved to treat rheumatic disease in the U.S.1 Infliximab-dyyb has received approval for almost…
Opinion: Adhering to Standards of Care Helps Manage Risk
Medicare and other third-party payers have started predicating reimbursement on adherence to standards of care. Post hoc chart reviews have resulted in substantial take-backs for failure to adhere to those values in cardiology, pulmonology and expanding to other areas. Outpatient medicine is also being subjected to such scrutiny. The question of standards and who sets…
3 Cases of Glomus Tumor—An Unusual Cause of Hand Pain
Hand and digit pain are common presenting symptoms to primary care physicians, rheumatologists, physiatrists and neurologists. There are many causes, but quality and location of the pain can be important clues to the diagnosis. Glomus tumors, neurovascular hamartomas of the glomus body, are an uncommon cause of hand pain. The glomus unit itself is a…
Rheumatologists on the Move, May 2016
Associate Editor of The Rheumatologist on Working Sabbatical Maura Daly Iversen, PT, DPT, SD, MPH, professor and chair of the Department of Physical Therapy, Movement, and Rehabilitation Sciences at Northeastern University, a behavioral scientist in the Division of Rheumatology, Immunology, and Allergy at Brigham and Women’s Hospital, a lecturer at Harvard Medical School, Boston, and…
Ustekinumab Improves Spondylitis in Patients with Psoriatic Arthritis
NEW YORK (Reuters Health)—The anti-interleukin (IL)-12/IL-23 monoclonal antibody ustekinumab improves signs and symptoms of spondylitis in patients with psoriatic arthritis, according to a post-hoc analysis of data from the PSUMMIT-1 and PSUMMIT-2 trials. “This treatment did seem to have a benefit on axial symptoms,” Dr. Arthur Kavanaugh from the University of California San Diego, La…
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