April 5, 2016, marks a revolutionary day in the treatment of autoimmune diseases: The U.S. Food and Drug Administration (FDA) approved an infliximab (Remicade) biosimilar, known as Inflectra (infliximab-dyyb). Infliximab-dyyb, which is administered by intravenous infusion, is the first biosimilar drug approved to treat rheumatic disease in the U.S.1 Infliximab-dyyb has received approval for almost…
Never underestimate the power of dreams and the influence of the human spirit. … The potential for greatness lives within each of us. —Wilma Rudolph, U.S. Olympic sprinter & winner of three gold medals From Spinnaker to Wheelchair It can be an unnerving experience when the patient you are about to see is young and…
The human intestinal microbiota is home to more than 1,000 bacterial species, containing approximately 3 million genes, many of which code for functions that have the potential to affect human physiology.1 Smaller numbers of organisms are also present in the skin, upper gastrointestinal tract, female reproductive tract and the oro- and nasopharynx. As tools have…
The microbiome comprises diverse microbial flora, including bacteria, viruses and fungi, that live on mucosal surfaces, predominantly the skin and digestive tract. Microbes evolved billions of years prior to the development of modern Homo sapiens 200,000 years ago; we have always existed with their ubiquitous presence. Despite this, the first microbe was not visualized until…
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 On Jan. 16, 2016, EMA granted marketing authorization in the European Union for Benepali to be used to treat rheumatoid arthritis (RA), psoriatic…
The FDA has received an application to expand the use of etanercept to treat plaque psoriasis in pediatric patients. Boehringer Ingelheim and AbbVie have announced a collaborative partnership to develop treatments for multiple autoimmune diseases. And gerilimzumab may prove safe and effective for treating inflammatory diseases at very low doses…
In a 52-week clinical trial, patients with plaque psoriasis who took secukinumab achieved greater sustained skin clearance then those taking ustekinumab. Also, three clinical trials showed ixekizumab improves work productivity in patients with plaque psoriasis…
CR845—an oral, peripherally selective kappa opioid agonist—is currently in Phase 2 trials for the treatment of pruritus, and acute and chronic pain.1 Eighty patients with hip osteoarthritis (OA) or knee OA were randomized to receive treatment with 0.25 mg, 0.5 mg, 1.0 mg or 5.0 mg CR845 twice daily for two weeks. Safety assessment, pharmacokinetics…
Currier McEwen, MD, was a truly remarkable rheumatologist, accomplishing more than even the best of us could imagine. He is even more recognized in the horticulture community as a hybridizer of flowers. He was born Osceola Currier McEwen on April Fool’s Day, 1902, in Newark, N.J., and died in 2003, at the age of 101….