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AstraZeneca Pushes Forward on Brodalumab Development
Despite Amgen's withdrawal as a co-developer of brodalumab, the anti-IL17A monoclonal antibody, AstraZeneca has announced it will push its plan to develop the drug. Brodalumab is currently in phase III trials for use in psoriasis, psoriatic arthritis and ankylosing spondylitis.
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Cymbalta Lawsuit Alleges Downplay of Withdrawal Symptoms
An estimated 250 people have filed lawsuits against Lilly claiming the company failed to warn users of Cymbalta that they may suffer withdrawal symptoms if the drug was stopped abruptly, including suicidal thoughts and electric shock-like sensations.
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Vitamin D Fails in Postmenopausal Osteoporosis Prevention
JAMA reports that investigators from the University of Wisconsin in Madison studied the impact of vitamin D supplements on 230 women who were at least five years past menopause but no older than 75, and without osteoporo
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NSAIDs are Risky in Patients with Chronic Kidney Disease
Little is known about what happens when NSAIDs are used in patients with chronic kidned disease (CKD), especially those with hypertension.
Read ArticleB cell Inhibition with Epratuzumab Fails in Two Phase III Lupus Trials
Targeting B cells in systemic lupus erythematosus, the prototypic autoimmune disorder, has long been an attractive target for researchers. Despite negative trials with rituximab and the limited success of belimumab, efforts to inhibit B cell activity have continued.
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Gut Dysbiosis in RA Reflects Activity, Serology and Response
Using a metagenome-wide association study (MGWAS) of fecal, dental and salivary samples from rheumatoid arthritis and healthy controls, Zhang et al showed that gut and oral microbiomes are highly concordant and that in RA there is a distinct dysbiosis with less Haemophilus spp.
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Not All Placebos are Equal: The Needle is Mightier than the Pill
Placebos are necessary to determine the “true effect” of any medical intervention. As such, they have become the cornerstone of evidence-based medicine, randomized controlled clinical trials and novel drug development.
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2015 Guidelines for Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrosing form of interstitial pneumonia, with poor survival rates of nearly 50% at 3 years.
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Tacrolimus Tops Other DMARDs as Induction Therapy for Lupus Nephritis
Metanalysis of nine clinical trials and 972 lupus patients examined the comparative efficacy of tacrolimus, mycophenolate (MMF) and cyclophosphamide (CYC) as induction therapy for lupus nephritis.
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Outcry Over the Cost of Drugs
Several news articles have addressed the rising concern by patients and physicians over the cost of newer drugs. This issue comes to a head as more than 100 oncologists from top cancer hospitals around the U.S.
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DSB: Drug Shortages July 2015
Several drugs continue to be in short supply, posing significant problems for patients. Foremost on this list is leflunomide (Arava) which is backordered for both 10 mg and 20 mg tablets.
Leflunomide Shortage
Read ArticleRituximab Induced Serum Sickness
Karmacharya and colleages have reviewed 33 cases of rituximab-induced serum sickness. Half of these patients had the classic triad of SS fever, rash, and arthralgia and a self-limiting course. The time to onset after infusion was greater with the first dose of rituximab c
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Increasing Age May Increase Miscarriage Risk in RA
At EULAR 2015, Brouwer and colleagues reported on their cohort of 162 evaluable pregnancies in 239 Dutch women enrolled during 2002-2010 in the nationwide Pregnancy-Induced Amelioration of Rheumatoid Arthritis (PARA) study – a large prospective cohort of pregnant RA patients.
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IL-1 Inhibition May Be an Alternative Treatment for Behcet's
Behcet's disease is difficult to manage, especially if the goal is to avoid corticosteroids.
Read ArticleAlpha-1-Anti-Trypsin-Fc Fusion Protein Ameliorates Gouty Arthritis
Gout is the most common inflammatory arthritis affecting adults and, probably, one of the most underestimated.
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Lithium May Have Chondroprotective Effects in OA
Several studies have suggested that lithium chloride exhibits significant chondroprotective effects on cartilage degradation (in animal models) in response to inflammatory cytokines.
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Intracranial Hemorrhage with Combined NSAID and Antidepressant Use
The British Medical Journal reports that the combined use of NSAIDs and anti-depressants were associate with higher rates of intracranial bleeding within 30 days of initiation (Citation source http://buff.ly/1gF3uEJ).
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DSB Reports & Updates – July 2015
FDA Scours the Internet for Safety Signals. A Bloomberg News report shows how the FDA is using Google or Yahoo keyword searches to identify new safety signals or drug interactions, often more than a year before they were brought to light by the FDA based on prior methodologies de
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Xeljanz Warnings on Shingles Updated by FDA
The MedWatch June 2015 safety labeling changes were published yesterday, and updated the warnings for Xeljanz (tofacitinib). "The risk of herpes zoster is increased in patients treated with Xeljanz and appears to be higher in patients treated with Xeljanz in Japan."
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IRB Conflicts of Interest Persist
Committees at academic institutions that make decisions on research and clinical trials may be conflicted, as nearly one-third of IRB members have some ties to the pharmaceutical industry.
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