New molecular entity: Tocilizumab (Actemra) was approved in January 2010, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.
This January, FDA approved tocilizumab intravenous infusion for marketing in the United States. Tocilizumab is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies (ie, infliximab). Rheumatoid arthritis, a chronic disease mainly characterized by inflammation of the lining or synovium of the joints, is estimated to affect 1.3 million Americans.
Efficacy. The efficacy of tocilizumab has been assessed in 5 multicenter, randomized, double-blind, placebo- or active-controlled trials. Each trial enrolled adult patients with rheumatoid arthritis having at least 8 tender and 6 swollen joints at baseline. Administered every 4 weeks, tocilizumab has been studied as monotherapy, in combination with methotrexate in patients not responding adequately to disease modifying anti-rheumatic drugs (DMARD), or in combination with methotrexate in patients not responding to one or more TNF antagonist therapies. In each of these trials, the proportion of patients achieving the American College of Rheumatology (ACR) 20, 50, and 70 end points at 24 weeks while taking tocilizumab 8 mg/kg was greater than control patients receiving either placebo or methotrexate. Typically, patients receiving tocilizumab 4 mg/kg had a poorer response in clinical trials than those receiving 8 mg/kg.
Safety. Common side effects of tocilizumab (occurring in greater than 5% of treated patients) include upper respiratory tract infections (common cold, sinus infections), headache, and hypertension. Other serious side effects of tocilizumab include perforation of the gastrointestinal tract, changes in blood test results (elevated liver function tests [AST or ALT], elevated serum lipids [total or low-density lipoprotein cholesterol or triglycerides], reduced neutrophil and platelet counts), increased risk of hepatitis B infection in those already carrying the virus, increased risk of nervous system problems (development of multiple sclerosis), malignancies, and serious allergic reactions. Patients treated with tocilizumab are also at an increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis, bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, tocilizumab therapy should be stopped until the infection is controlled.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.