Debate continues about how biosimilars that are emerging to treat rheumatic diseases will be named and monitored, said panelists at a recent meeting in Washington, D.C.—Biosimilars in the United States: Next Steps. Angus Worthing, MD, FACR, FACP, a member of the ACR’s Government Affairs Committee, shared rheumatologists’ concerns as these new therapies come to market….
Arthritis Patients Lack Knowledge about Safe Use of Biologics
NEW YORK (Reuters Health)—Many patients with arthritis lack the knowledge to use their biologic treatments safely, researchers from France report. “Some patients are at risk of poorly managing their biologic therapy, especially patients living alone, in a large city, patients with low education level, or (patients who are) unemployed,” Dr. Anne-Christine Rat from CHU de…
Adalimumab & Infliximab Remain in Newborns after Delivery
A recent study showed that, when administered during pregnancy, infliximab takes longer to clear an infant’s system than adalimumab…
Rheumatology Drug Updates: Etanercept for Pediatric Plaque Psoriasis
Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with…
Adalimumab Drives Regulatory T Cell Expansion by Binding to Membrane TNF
NEW YORK (Reuters Health)—The anti-tumor necrosis factor (TNF) antibody adalimumab drives regulatory T cell (Treg) expansion in rheumatoid arthritis (RA) by binding to membrane TNF, researchers from the UK report. “These results show that adalimumab enhances the anti-inflammatory actions of TNF to increase regulatory T cell activity,” Dr. Michael R. Ehrenstein from University College London,…
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…
Baricitinib Has Promising Clinical Trial Results for Treating RA
Recent clinical trials have shown that baricitinib is safe and effective for treating patients with rheumatoid arthritis who have proved non-responsive to multiple biologic treatments…
TNF Blocking Drugs Persist in Infants after Exposure In-Utero
NEW YORK (Reuters Health)—Babies born to mothers who took anti-tumor necrosis factor (anti-TNF) agents during pregnancy have detectable drug in their bodies up to 12 months of age, new findings show. These infants should therefore not receive live vaccines during their first year of life, Dr. Mette Julsgaard of Aarhus University Hospital in Denmark and…
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…
Biosimilars: Expanded Treatment Options
Soon, biosimilars will be available as treatment options for our patients. Biosimilars are being introduced to the U.S. market in the hope that they will spur competition and drive down the price of these expensive medicines. Previous articles in The Rheumatologist have touched on various issues surrounding these new therapies, and everyone in the rheumatology…
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