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Sandoz Etanercept Biosimilar Voted for Approval by FDA Arthritis Advisory Committee
The Food and Drug Administration’s Arthritis Advisory Committee (AAC) yesterday recommended that the Sandoz etanercept (Enbrel) biosimilar (GP-2015) be approved for use in the United States.
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FDA Approves Xiidra (Lifitegrast) for Dry Eyes
MedScape has reported that the US Food and Drug Administration (FDA) has approved lifitegrast ophthalmic solution (Xiidra, Shire) for the treatment of signs and symptoms of dry eye disease.
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FDA Arthritis Advisory Committee Recommends Approval of Adalimumab Biosimilar
The Food and Drug Administration’s Arthritis Advisory Committee yesterday recommended that Amgen biosimilar (ABP 501) to Humira (adalimumab) be approved for use in the United States.
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FDA Says Cryotherapy Lacks Evidence, Poses Risks
Cryotherapy is a non-FDA approved treatment that has been promoted to treat post-athletic injury, osteoarthritis,rheumatoid arthritis, fibromyalgia, alzheimers, migraines, asthma, multiple sclerosis, etc. Cryotherapy may be as simple as ice packs on a localized portion of the body, such as the lower back, or may involve whole body cryotherapy.
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Academic Female Physicians Paid Less than Male Counterparts
Female academic physicians at public medical schools had lower average salaries than their male counterparts, a disparity that was only partly accounted for by age, experience, medical specialty, faculty rank and other factors, according to an article published online by JAMA Internal Medicine.
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Adalimumab Approved for Uveitis
Autoimmune ophthalmic disease is a frequent challenge to rheumatologists from both a diagnostic and therapeutic perspective. Approved therapies are limited and have only been infrequently or comfortably utilized by rheumatologists and autoimmune ophthalmologists.
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Cancer Risk Lower with TNF inhibitors in Rheumatoid Arthritis
Since the introduction of TNF inhibitors nearly 20 years ago, concerns over a potential associated cancer risk have abounded. The recent ACR RA treatment guidelines have addressed this recently, stating that patients with any solid tumor cancer or risk thereof should be treated as if they ha
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A $20 Drug Company Meal Yields 2-5 Times More Prescriptions
Accepting a single pharmaceutical industry-sponsored meal was associated with higher rates of prescribing certain drugs to Medicare patients by physicians, with more, and costlier, meals associated with greater increases in prescribing, according to an article published online by JAMA Internal Me
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EULAR 2016 Drug Safety Report
The EULAR Annual European Congress of Rheumatology meeting was held in London from June 8-11, 2016 and was well attended by thousands. This year’s meeting had over 2,000 poster displays, and the EULAR 2016 Congress presented new recommendations on the management of rheumatoid arthritis, spondyloarthritis, and fibromyalgia.
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RheumNow Week in Review – 17 June 2016
Dr. Jack Cush reviews the news, reports and highlights from EULAR and the last 2 weeks from RheumNow.com.
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European Registries Show No Melanoma Risk with Biologics
The combined analysis of 130,315 rheumatoid arthritis patients from 11 European registries did not reveal an association between invasive (malignant) melanoma and the use of biologic therapies.
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Dramatic Results for Interferon Blocker in SLE
Blocking the type 1 interferon receptor with the monoclonal antibody anifrolumab shows promise as a treatment for moderate-to-severe systemic lupus erythematosus (SLE), according to a phase IIb study presented here.
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Long-Acting Opioids Associated with Higher Mortality Risk
Prescription of long-acting opioids for chronic noncancer pain was associated with an increased risk of all-cause mortality, including deaths from causes other than overdose, compared with anticonvulsants or cyclic antidepressants, according to a study appearing in the June 14 issue of JAMA.
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No Increased Risk of Colitis Flares in Secukinumab Trials
No increased incidence of inflammatory bowel disease has been seen among patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis treated with secukinumab (Cosentyx) in the clinical trial programs for this interleukin (IL)-17A inhibitor, a researcher reported here.
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U-ACT-Early and the Benefits of Tocilizumab
Lancet has published the results of the U-ACT-early study assessing the efficacy of monotherapy versus combination therapy using an interleukin-6 receptor-blocking monoclonal antibody, tocilizumab, in patients with rheumatoid arthritis.
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Ixekizumab Success with the UNCOVER Trials in Psoriasis
The NEJM today published the results of two phase-3 trials (UNCOVER-2 and UNCOVER-3) demonstrating the efficacy of ixekizumab (a monoclonal antibody against interleukin-17A) in the treatment of moderate-to-severe psoriasis.
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Pre-Clinical Use of Rituximab Forestalls Rheumatoid Onset
The results of the PRAIRI study were presented today at EULAR 2016 in London. These early findings suggest that individuals "at-risk" to develop rheumatoid arthritis (RA) may benefit from a short course of intravenously rituximab therapy.
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EULAR: Tofacitinib Effective in Ankylosing Spondylitis
Desiree van der Heidje, MD, PhD presented the results of a 16-week, phase II, dose-ranging study of tofacitinib (TOFA) in patients with active ankylosing spondylitis.
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GiACTA Study Shows Benefit of Adding Tocilizumab to Steroid Taper in Giant Cell Arteritis
The GiACTA study has published its top line results demonstrating the efficacy of adding tocilizumab (TCZ) to steroid-tapered therapy in patients with giant cell arteritis (GCA).
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Gastrointestinal Perforation Risk increased for Tofacitinib and Tocilizumab
Gastrointestinal perforations (GIP) are not historically believed to be a common or uncommon complication. Hence, when this was noted in the tocilizumab (TCZ) and tofacitinib (TOFA) developmental trials, it was a curious if not perplexing finding.
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