Etanercept Biosimilars A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection…
Most Rheumatologists Want FDA to Better Regulate Biosimilars
In a survey, the Coalition of State Rheumatology Organizations found a consensus among rheumatologists that the FDA should increase safety for biosimilar therapies via naming and labeling regulations…
Americans Want Medicare to Help Negotiate Down Drug Prices
NEW YORK (Reuters)—A vast majority of Americans say the Medicare health program for the elderly should be able to negotiate with drug companies to set lower medication prices, a practice currently prohibited by law, according to a survey released on Friday. The poll conducted by the Kaiser Family Foundation found that 87% of people surveyed…
Glucocorticoid Use for Rheumatoid Arthritis Still Sparks Debate
Glucocorticoids: The Debate Continues Déjà vu … In past decades, rheumatologists have seen, heard, practiced and taught much of what has been argued in the “ongoing debate” on the use of glucocorticoids (GCs) in the management of rheumatoid arthritis (RA).1 It is heartening to note that eminent professors have stuck to their premise all these…
Restoration of Sleep Physiology vs. Sedation for Sleep Disorders, Fibromyalgia
Sleep disturbance is an important medical problem, requiring intervention, not simply to reduce latency to its onset, but to ensure achievement of the depth of sleep that has been documented to restore homeostasis and prevent the falls that are responsible for so much morbidity and mortality.1 Sleep disturbance is present in 50% of people over…
Anti-TNF Agents May Improve Clinical Symptoms of Ankylosing Spondylitis
Ankylosing spondylitis primarily affects the joints and ligaments of the spine, but may also have an impact on other joints. Patients experience pain and stiffness that limit mobility in the back and other affected joints. Symptoms can come and go, last for long periods of time and be severe. Anti-tumor necrosis factor (anti-TNF) drugs are…
Rising Costs of Biologics in the U.S. Suggest Need for Negotiation Ability
The costs of some disease-modifying therapies outpace prescription drug inflation, saddling insured patients with thousands of dollars in out-of-pocket payments and delayed or denied coverage, two new studies have shown. Disease-modifying therapies for multiple sclerosis are rising in cost five to seven times faster than inflation and cost more in the United States than in…
Biosimilar for Infliximab Launched in Europe
Plus, updates on arhalofenate, ALO-02, and other rheumatology drug news, safety information
The ACR Recommends Cautious Approach as Biosimilars Enter U.S. Market
With the U.S. FDA’s first approval of a biosimilar drug earlier this month, rheumatologists stress the need to ensure safety, efficacy of such drugs in treating rheumatic diseases
2014 ACR/ARHP Annual Meeting: Rheumatoid Arthritis Management Treatment Recommendations
The ACR shares highlights of in-development guidelines for RA combination strategies, live vaccines and biologics
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