Last year, the FDA was busy with new biologic and other drug approvals, new and expanded drug indications, and important safety updates relevant to rheumatology…
Amgen Wins U.S. Patent Battle on Arthritis Drug Enbrel
(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….
British Columbia Will Be First Canadian Province to Switch Patients to Biosimilars
TORONTO/MONTREAL (Reuters)—The Canadian province of British Columbia said on May 28 that its public drug plan will switch as many as 20,400 patients from three branded biologic drugs to cheap near-copies called biosimilars, saving an estimated C$96.6 million ($71.9 million) over three years. The new policy from the province’s PharmaCare program targets Johnson & Johnson’s…
DMARDs & Biologics Info for Rheumatology Nurses
SAN DIEGO—In a presentation on what rheumatology nurses should know in their daily practice about disease-modifying anti-rheumatic drugs (DMARDs) at the 2017 ACR/ARHP Annual Meeting Nov. 3–8, Jessica Farrell, PharmD, highlighted the importance of educating and counseling patients about the range of treatments and applications for rheumatologic conditions. Dr. Farrell, a clinical pharmacist at the…
How to Avoid Insurance Denials for Prescribing a Biologic Without MTX in Concert
The Insurance Subcommittee (ISC) of the ACR’s Committee on Rheumatologic Care (CORC) has recently received a number of reports from members regarding denials for biologics for patients not on methotrexate. To help avoid an often-lengthy appeals process, the ACR/ARHP recommends that members document a patient’s history of methotrexate intolerance or contraindication at every visit. What…
Should Patients with Rheumatic Disease Switch from Biologic to Biosimilar?
SAN DIEGO—Should patients with rheumatic diseases switch from a biologic to its biosimilar? At the 2017 ACR/ARHP Annual Meeting’s Great Debate, held Nov. 5, two rheumatologists argued whether to switch or stay put based on safety, efficacy and potential cost savings. First to the podium to make the case for switching, Jonathan Kay, MD, tweaked…
Safety, Tolerability & Pharmacodynamics of ABT-122 in Patients with RA
The introduction of biologic disease-modifying anti-rheumatic drugs (DMARDs) has greatly expanded the treatment options for managing rheumatoid arthritis (RA). In many patients, biologic DMARDs improve clinical symptoms, improve function and slow disease progression. Biologic DMARDs are recommended as add-on treatment to conventional synthetic DMARDs, such as methotrexate (MTX) in patients who experienced an incomplete response…
Biosimilars Great Debate: To Switch or Not?
SAN DIEGO—Should patients with rheumatic diseases switch from a biologic to its biosimilar? At the 2017 ACR/ARHP Annual Meeting’s Great Debate, held Nov. 5, two rheumatologists argued whether to switch or stay put based on safety, efficacy and potential cost savings. First to the podium to make the case for switching, Jonathan Kay, MD, tweaked…
HSCT for Severe Autoimmune Diseases
Despite the innovations of new biologics and disease-modifying anti-rheumatic drugs, a large unmet need remains for patients with rheumatic autoimmune disease. Treatment remains limited for many conditions, including for conditions with a dim prognosis, such as systemic sclerosis.1 One promising treatment avenue is hematopoietic stem-cell transplantation (HSCT). Here, we provide background on HSCT for severe…
Clinical Guidelines for Sjögren’s Syndrome Focus on Biologics, Fatigue, Inflammatory Musculoskeletal Pain
The first clinical practice guidelines for Sjögren’s syndrome have been released, the culmination of an initiative by the Sjögren’s Syndrome Foundation.1 These standard-of-care recommendations are intended to provide consistency in practice patterns, inform coverage and reimbursement policies, lead to the design and implementation of educational programs, highlight the needs for future research and fill a…
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