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Biologics/DMARDs

Ixekizumab Clinical Trials Continue; FDA Updates Warning Label for Varenicline

Michele B. Kaufman, PharmD, CGP, RPh  |  June 15, 2015

It seems to have begun in Norway, the international pressure to switch patients from well-known brand biologic agents, such as Remicade (infliximab), to biosimilar agents, due to a significant cost advantage.1 This biosimilar came with a 39% price markdown last year compared with the brand, and when Norway called for bids, the discount went to…

Tofacitinib Effective for Treating Moderate-to-Severe Chronic Plaque Psoriasis

Reuters Staff  |  June 12, 2015

NEW YORK (Reuters Health)—Tofacitinib is better than placebo (and noninferior to etanercept) for treating patients with moderate-to-severe chronic plaque psoriasis, according to Pfizer’s OPT Compare trial. In an earlier 12-week, phase 2b, dose-ranging trial, the oral JAK inhibitor tofacitinib proved to be more effective than placebo for treating patients with moderate-to-severe plaque psoriasis. Based on…

Data Collection Drives Evaluation of Psoriasis Treatments

Michele B. Kaufman, PharmD, BCGP  |  June 10, 2015

For six years, the Psoriasis Longitudinal Assessment and Registry (PSOLAR) has collected data to assess the infection risk for drugs treating systemic psoriasis.

Biologic Drugs for Psoriasis Are Rarely Stopped for AEs

Joan Raymond  |  June 6, 2015

NEW YORK (Reuters Health)—Real-world psoriasis patients receiving biologic therapies rarely stop taking the drugs because of adverse effects, researchers say. Although data from long-term registries have shown similar results, “the demographics of patients in registries are somewhat different than those of patients in real-world practices,” Dr. Jensen Yeung told Reuters Health by email. “I have…

Clinical Trials Ongoing for Brodalumab

Michele B. Kaufman, PharmD, BCGP  |  June 5, 2015

Brodalumab, an interleukin (IL) 17 inhibitor, is currently in early clinical trials (Phase 1b and Phase 2) for a number of different autoimmune diseases.1 Amgen recently terminated its co-development and commercialization agreement with AstraZeneca for the brodalumab investigational program in trials for moderate to severe plaque psoriasis, psoriatic arthritis and axial spondyloarthritis. Amgen’s decision to…

Antibodies to Remicade Cross-React with Biosimilar Remsima

Will Boggs, MD  |  May 28, 2015

NEW YORK (Reuters Health)—Antibodies to infliximab in patients with inflammatory bowel disease (IBD) treated with Janssen’s Remicade cross-react with the biosimilar Remsima from Celltrion (distributed as Inflectra by Hospira in the U.S.), researchers from Israel report. “The cross-reactivity of anti-Remicade antibodies with Remsima attests to shared immune triggering points (epitopes) on these two agents, and…

Rising Costs of Biologics in the U.S. Suggest Need for Negotiation Ability

Rob Goodier (Reuters Health)  |  May 21, 2015

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…

First Biosimilar Drugs Approved in U.S., Canada

Michele B. Kaufman, PharmD, BCGP  |  May 15, 2015

The first biosmilar products have been approved in the U.S. and Canada, following Europe’s early lead. Canada approved its first biosimilar monoclonal antibody (mAb) therapy, known as Inflectra (infliximab), on March 30, 2015.1 In Canada, biosimilars are being called subsequent entry biologic (SEB) agents. Inflectra is approved for treating patients with rheumatoid arthritis (RA), ankylosing…

Biosimilar for Infliximab Launched in Europe

Michele B. Kaufman, PharmD, BCGP  |  April 1, 2015

Plus, updates on arhalofenate, ALO-02, and other rheumatology drug news, safety information

Infliximab, Tocilizumab Can Help in Large Vessel Vasculitis

Lara C. Pullen, PhD  |  March 13, 2015

Case studies show some patients with LVV can achieve remission after treatment with biological agents

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