As a veteran rheumatologist, I remember the clinical trials of etanercept’s (Enbrel’s) efficacy. And when the drug was first approved in 1998, I participated in those clinical trials and realized the effectiveness was astonishing. It was easy to tell which patients were treated with etanercept vs. those who received placebo, even though both groups were… [Read More]
In a systematic literature review, researchers found that rheumatoid arthritis patients taking etanercept were less likely to discontinue their treatment than patients using any of five other tumor necrosis factor inhibitors…... [Read More]
NEW YORK (Reuters Health)—The biosimilar LBEC0101 is equivalent to etanercept (Enbrel) in treating patients with rheumatoid arthritis (RA) who respond inadequately to methotrexate, according to researchers from Korea and Japan. As Dr. Yeong-Wook Song tells Reuters Health by email, “LBEC0101 is comparable in efficacy, safety and immunogenicity profile to Enbrel.” The findings, he adds, could… [Read More]
In the U.S., a new formulation and an ergonomic delivery system for single doses of etanercept are now available for RA patients…... [Read More]
GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab… [Read More]
The FDA is considering an application for subcutaneous rituximab and has approved an application for etanercept to treat pediatric patients with plaque psoriasis…... [Read More]
Although it may not be available until 2017, the FDA approved the use of etanercept-szzs for multiple autoimmune diseases…... [Read More]
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel). The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition. The agency approved the drug as a biosimilar, meaning there is no… [Read More]
In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…... [Read More]
(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… [Read More]