On March 6, 2015 the Food and Drug Administration (FDA) approved the first biosimilar drug for use by patients in the United States (see FDA press release). The drug called Zarxio (filgrastim-sndz) is produced by Sandoz and is similar to Amgen’s Neupogen (filgrastim). Both are approved to treat certain kinds of cancers and bone marrow transplants.
Biologic medicines come from living organisms. They are different from chemical medicines in that they contain large and delicate biological molecules such as proteins, must be injected or infused since stomach acids would damage the molecules, and are usually much more expensive than chemical medicines due to development and complicated production costs. Given the high development costs associated with biologics, they are given an extended patent length of 12 years in the United States. When a chemical drug looses its patent protection, companies produce generics that are exact chemical matches. Generics are widely used and are much cheaper than the original drug. Given the complexity of biologics, exact chemical matches are replaced with scientific equivalency meaning that the biologic is similar in action but not exactly the same – thus the name “biosimilar” being used for these drugs (Entine, 2012).1
Some of the most popular RA biologic medicines stand to loose patent protection in the United States in next few years.
Read the rest of the article at http://rheumatoidarthritis.net/news/fda-approves-first-biosimilar-drug-whats-next-for-ra/.
Posted in Uncategorized | Tagged biologicals, biosimilars, FDA | Leave a Comment »
Rheumatoid arthritis is an autoimmune disease meaning that the immune system attacks itself. According to the American Autoimmune Related Diseases Association (AARDA), upwards of 50 million Americans suffer from over 80 identified autoimmune diseases. Some of the most common autoimmune diseases include rheumatoid arthritis, Crohn’s Disease, lupus, multiple sclerosis, psoriasis, and type 1 diabetes. Autoimmune diseases tend to run in families. Immunosuppresant drugs are the current treatments of choice for these diseases and they come with some serious potential side effects. Much more research is needed in order to fully understand these devastating diseases and to develop better treatments and cures. Unfortunately, autoimmune diseases get a smaller proportion of research dollars compared to cancer and heart disease.
Check out the AARDA website and Facebook page and get involved to raise awareness about autoimmune diseases.
Posted in Uncategorized | Tagged AARDA, Autoimmune disease | 1 Comment »
There’s a great scene in the classic 1975 movie Jaws where Fisherman Quint, Police Chief Brody, and Scientist Hooper are sitting around on a boat during the evening. The three are drinking and loosening up after a stressful day of chasing the shark. (Robert Shaw, the actor who played Quint, was reputed to have been wildly drunk during the filming of the scene.) Hooper and Quint are playing a clowning game of one ups-man-ship comparing their body scars. They pull up clothes to show their various badges of honor – some from school and bar room fights, some from burns, and others from clashes with various sea creatures. Brody feels like the odd man out as he only has an appendectomy scar to share. He lifts up his shirt, looks at his medical-induced scar, and then lowers his shirt deciding not to participate in the game…
…Rheumatoid arthritis is much like this script. Some of us may have physical reminders – scars so to speak – of our RA. These may come in the form of disfigured joints or as actual scars from surgeries intended to repair the damage done by RA. These outward signs are constant reminders to us about our condition.
Read the rest of the article at http://rheumatoidarthritis.net/living/comparing-ra-scars/.
Posted in Uncategorized | Tagged RA, scars, surgery | Leave a Comment »
Last Friday brought a 6th surgery in the past seven years. This is remarkable given the fact that the first 46 years of my life were relatively healthy with no major medical procedures. All surgeries have been connected with rheumatoid arthritis. Friday’s surgery was an outpatient procedure on the right elbow designed to remove damaged tendon and bone and to reattach tendon to the joint. It’s been an ongoing battle with both elbows for the past 18 months but other RA issues, primarily neck surgery and recovery last spring, took precedence.
The orthopedic surgeon who conducted the procedure specializes in hands and elbows. He said that he’s done numerous surgeries on the elbow and my tendon was one of the worse cases he’s seen. Healthy tendon tissue is typically smooth, white, with parallel lines. He characterized mine as mushy, gray, and undefined. After clearing out the tendon and removing damaged bone tissue, the remaining tendon was connected to other nearby healthy tendon. Holes were drilled in the bone to hold suture anchors that were used to reattach the remaining tendon to the joint.
The procedure was scheduled for early afternoon. After a long wait where drinking and eating were not allowed since the previous evening, a nasty migraine began to set in. The nurses stated that this is common due to dehydration. Lack of coffee probably didn’t help. They increased the saline drip line and provided a bag of ice. After waking from anesthesia, the migraine completely vanished. This was the easiest postoperative recovery in that there was no nausea or pain at the surgery site. The anesthesiologist said that he would just use infused anesthesia and avoid gases and narcotics that cause nausea. The surgeon used local injections of anesthesia to block pain. These lasted for at least 12 hours. Percocet, a combination of oxycodone and acetaminophen, is helping keep pain in check.
The arm was immobilized from above the elbow to the fingers. The dressing was changed after three days and the stitches will be removed after 10 days. Occupational therapy will begin at two weeks to slowly regain movement and strength.
There’s never a dull moment with RA and this episode is just part of the ongoing battle. After knowing that the surgery will be infection free, I will begin another part of the battle by adding a new drug called CellCept alongside current Rituxan infusions.
Posted in Uncategorized | Tagged anesthesia, CellCept, migraine, narcotics, orthopedic surgeon, RA, rheumatoid arthritis, Rituxan, Rituximab, surgery, tendon | 14 Comments »
Today, February 2, is Rheumatoid Awareness Day. In honor of this day, I put together a list of a few awareness dreams…
1. Rheumatoid disease is no longer confused with general forms of arthritis.
2. Disability can be easier to obtain if needed.
3. Scientists move beyond treatments and find an actual cure.
4. Rheumatoid disease is viewed as a systemic disease affecting many organs and tissues.
5. The genetic and environmental factors behind rheumatoid disease are accurately unraveled which lead to better treatments and a cure.
6. Research funds for rheumatoid disease are given proportionally to the actual impact of the disease.
Read more about the day at the Rheumatoid Patient Foundation site.
Get involved and spread awareness about Rheumatoid Disease!
Posted in Uncategorized | 3 Comments »
So much for a new year’s resolution to avoid surgery in 2015. Surgery on my right elbow is now scheduled for February 6th – we’re waiting until after my son’s wedding at the end of the month. This will be my 6th RA-related surgery. Both elbows give fits including persistent pain and tenderness but the right one has been the bigger beast probably because I’m right handed. In August 2013, first symptoms were noted. An MRI in October 2013 showed a 50% tear in a tendon. Enthesitis is the term for damage in an area where a tendon connects muscle to bone and such soft tissue damage is common in rheumatoid arthritis in general an in my case specifically. The orthopedic surgeon gave a cortisone steroid injection in November 2013. Occupational therapy was done from December 2013 to February 2014 but it was stopped as progress was not realized. Finally, in November 2014 a novel platelet-rich plasma injection was tried to no avail. The orthopedic surgeon, who specializes in hands and elbows, said that all conservative treatments failed to help and surgery would be required. He indicated that the surgery would include an incision across the elbow, removal of the damaged tendon, shaving off damaged bone tissue, and using anchor sutures to reattach healthy tendon to the bone. Anchor sutures involve drilling holes in the bone and inserting anchors which hold special permanent suture material. The arm and wrist will be immobilized for a few weeks. Occupational therapy is already scheduled starting two weeks after the procedure. My rheumatologist wanted to add a new DMARD, CellCept, to help with Rituxamab infusions. But now we’ll wait until after surgery to help avoid any infection complications.
While surgery is always a last effort, it’s time to take care of this ongoing issue as the pain is non-stop and use of the arm is limited. Updates will be posted as the process unfolds.
Posted in Uncategorized | Tagged achilles tendon, anchor suture, CellCept, cortisone injection, DMARD, enthesis, occupational therapy, plasma-rich platelet injection, PRP, RA, rheumatoid arthritis, Rituxan, Rituximab, surgery | 10 Comments »