The FDA recently approved a biosimilar (trade name, Amjevita) to Humira (adalimumab). A biosimilar is a biological product that is highly similar to the originator drug, and has no clinical differences in terms of safety and effectiveness.
“We cannot give medical advice over the Internet but suffice it to say that patients who need anti coagulation for cardiac issues are prescribed these and just more closely monitored.”–Dr. Sunanda Kane, M.D.
One of the first questions that people diagnosed with inflammatory bowel disease (IBD) have is, “What can I eat, and will changing my diet help with the symptoms or even cure my disease?” The Crohn’s & Colitis Foundation of America (CCFA) has been given $2.5 million to investigate the value of a carbohydrate-rich diet and a Mediterranean-style diet in preventing relapse in Crohn’s patients who are currently in remission. People enrolled will be randomized to one of the two diets, and free meals will be provided for six weeks through a meal-delivery service. Patients can continue purchasing meals afterwards. There will be multiple sites across the country, and Mayo Clinic in Rochester, Minnesota is one of them.
The FDA recently approved of a biosimilar (CT-P13) to infliximab, which is used for treating IBD patients, as well as patients suffering from rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The new drug would be the first biosimilar monoclonal antibody approved in the United States. Dr. Edward Loftus, M.D., explains how biosimilars work, and discusses some of the issues surrounding this medication, and its potential benefits and drawbacks.
A new study, published in Gastroenterology, suggests that long-term use of combination oral contraceptives may increase the risk for surgery among women with established Crohn’s disease. The research team evaluated the association between oral contraceptives and risk for Crohn’s disease complications, including need for surgery and steroid use. They found that steroid use did not appear to increase with past or current use of oral contraceptives, and that the increased risk for surgery was only associated with combination oral contraceptives. Dr. Sunanda Kane, M.D., explains why this may not be a definitive study and puts the results into perspective.
Vedolizumab is a monoclonal antibody that selectively prevents the infiltration of leucocytes into the gastrointestinal submucosa.
The efficacy and safety of vedolizumab in adults with IBD have been demonstrated in several clinical trials with follow-up to 1 year.
What are the new findings?
Treatment with vedolizumab for up to 5 years in a population of over 2800 patients demonstrated a favourable safety profile.
Vedolizumab is not associated with an increased risk of serious or opportunistic infections, and the rate of malignancy (0.1/100 person-years) is consistent with that observed in patients with IBD normally.
Although a favourable benefit-risk profile makes vedolizumab a useful option for the long-term treatment of IBD, researchers still need to better understand and observe how its safety profile evolves over time.