For six years, the Psoriasis Longitudinal Assessment and Registry (PSOLAR) has collected data to assess the infection risk for drugs treating systemic psoriasis.
U.S. NIH Drug Facility Suspended after Contamination Found
(Reuters)—The National Institutes of Health said on Thursday it had suspended operations of a facility that makes products used for clinical research after the discovery of fungal contamination in two vials of albumin. Vials made from the same batch of albumin had been administered to six patients, though it is not known if those were…
Biologic Drugs for Psoriasis Are Rarely Stopped for AEs
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
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…
High Cost of DMARDs Could Limit Medicare Patients’ Treatment Adherence
The high out-of-pocket costs of biologic disease modifying antirheumatic drugs (DMARDs) place “enormous financial strain” on Medicare beneficiaries and may limit therapy adherence, according to the lead author of a national investigation into Part D coverage and cost-sharing structures. Recently published online in Arthritis & Rheumatology, the study analyzed 2,737 Part D plan formularies for…
Antibodies to Remicade Cross-React with Biosimilar Remsima
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…
AstraZeneca Hit after Psoriasis Drug Linked to Suicide Fears
LONDON (Reuters)—AstraZeneca’s hopes of topping $45 billion in revenue by 2023 have been dealt a blow by a problem with an experimental psoriasis drug that the drugmaker had viewed as a potential billion-dollar plus seller. Amgen, its partner on the project, announced late on Friday it was ending a collaboration to develop brodalumab after suicidal…
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…
FDA Issues Safety Alerts for Bisphosphonates & SGLT2 Inhibitors
Safety The Food and Drug Administration (FDA) has updated the Warnings and Precautions sections of prescribing information for the bisphosphonate agents, including risedronate sodium tablets and combinations with calcium (Actonel/Atelvia), alendronate and combinations with vitamin D (Binosto/Fosamax), ibandronate (Boniva), etidronate (Didronel) and the RANK-ligand inhibitor denosumab (Prolia/Xgeva).1 This information relates to an increased risk for…
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