Novel Treatment for Multiple Sclerosis
Neuromuscular and Movement Disorders Among Interest of Southeast's Neurologist
Under strict federal guidelines, Southeast Hospital is offering an innovative treatment for multiple sclerosis that continues to show promise to slow down the often crippling effects of this central nervous system disease.
The treatment, which uses the drug Tysabri (natalizumab), is given intravenously every four weeks to patients who have been diagnosed with the relapsing form of MS and who have not responded or tolerated other drug therapies. The treatment is offered at Southeast's Infusion Services.
"The treatment is strictly monitored by the staff at our certified outpatient infusion center as well as by the prescribing physician," says Aaron Koonce, DO, of the Neurosciences Center at Southeast Hospital. "Because multiple sclerosis is an interest of mine, I hope to guide the care of residents who have MS and offer the latest treatments, including Tysabri."
How It Works
Tysabri is a monoclonal antibody that binds to white blood cells and prevents them from entering the brain and spinal cord. It is thought that in patients with MS, these cells attack the nervous system in the brain, spinal cord and nerves. The drug showed promise during clinical studies and was first approved by the Food and Drug Administration in late 2004. In a matter of months, however, the drug was removed from the market after three patients developed a deadly neurological virus. After a rigorous review, investigators found that those patients also were on immunosuppressant drugs, which compromised their ability to fight off other illnesses while on Tysabri. In the summer of 2006, the FDA allowed Tysabri back on the market under strict criteria for physicians and infusion centers to evaluate and monitor patients on the drug. It is now available for use in the United States only through the TOUCH™ Prescribing Program developed by the drug's manufacturer, Biogen Idec, and its distributor, Elan Corporation.
"Currently, we have about four to five patients on Tysabri at any given time who have been referred by several different neurologists to our Infusion Services," says Terri Stuckey, BSN, RN, OCN, Assistant Nurse Manager of Infusion Services at Southeast. "We've offered the therapy for the past 18 months. Each patient must complete a pre-infusion checklist as part of the process to continue receiving the therapy."
The pre-infusion checklist is mandatory for participants in the TOUCH program. It includes questions to determine whether a patient's MS symptoms have worsened since the previous infusion, whether the patient has been prescribed new medications that may negatively impact infusion therapy, or if they've contracted specific medical conditions. If the patient answers "yes" to any question, infusion therapy is discontinued, and the patient is referred back to his or her physician for consultation and follow-up.
Both Infusion Services and Southeast's Pharmacy had to be certified as an approved provider before being named a TOUCH program provider. Staff underwent rigorous training to administer the drug and learn proper patient procedures.
Data provided by Biogen Indec and Elan Corporation as of the end of March 2008 shows that an estimated 15,300 patients are currently on Tysabri therapy. More than 2,700 physicians had approved the drug for their patients. Significantly, since the re-introduction of Tysabri as an approved treatment option for MS patients, there have been no more cases of progressive multifocal leukoencephalopathy (PML), the deadly neurological virus that prompted the initial withdrawal of the drug from the market.
If your patient needs infusion services, look no farther than Southeast Hospital. Staffed by Certified Oncology Nurses (OCN) who work closely with physicians throughout the treatment process, physicians may schedule patients for:
Bone marrow biopsy
Intravenous antibiotic therapy
P.I.C.C. line insertions
"There are other medications that improve the quality of life for patients with multiple sclerosis and Tysabri isn't appropriate for many patients," says Dr. Koonce, who has managed MS patients for several years in other clinic locations and hopes to be part of a new MS clinic here soon. "With all of the options available today and more being evaluated in clinical trials across the country, MS is no longer the devastating diagnosis it once was. It's not a life ending disease."
Diagnosis and Treatment
Multiple sclerosis is a challenge to both diagnose and treat. Diagnosis may take years, primarily because symptoms appear and then disappear and may or may not become permanent. An estimated 400,000 Americans have MS, most of who are diagnosed between the ages of 20 and 50. Symptoms can mimic other diseases. Among the common patient symptoms are: blurred vision, poor coordination, slurred speech, loss of balance, extreme fatigue, paralysis and problems with memory and concentration. Twice as many women as men have the disease. The symptoms occur when myelin, the protective coating around nerve fibers, is destroyed and sclerotic tissue forms and then scars the nerve fibers.
"It's a good idea for a referring physician to seek consultation or refer a patient to a specialist to determine whether a patient might have MS," says Dr. Koonce. "There also may be signs pointing to some other neurological disorder, so it's particularly important to evaluate the patient from a number of different vantage points to make an accurate diagnosis."
As a general neurologist, Dr. Koonce sees a wide range of patient concerns, including various neuromuscular disorders such as MS, along with peripheral neuropathy, chronic headaches, dementia, Alzheimer's disease and movement disorders such as epilepsy and Parkinson's disease. Following a comprehensive exam, non-surgical approaches are tried first.
In July 2008, Dr. Koonce attended a special movement disorders conference specifically related to Parkinson's disease. He is particularly excited about new therapies that will soon be available to patients. "New medications are being evaluated all of the time," he says. "One of the latest developments for the treatment of movement disorders are transdermal patches which deliver a set dose of a specific drug over a 24-hour period."
One patch, called the rotigotine transdermal system, or Neupro, was approved for use by the FDA in May 2007. It is the first and, so far, only transdermal patch approved for the treatment of early Parkinson's disease.
The Exelon Patch quickly followed and was approved by the FDA in July 2007. This patch, using a different drug, is the first transdermal system approved for Alzheimer's disease. The FDA also approved the Exelon patch for patients with mild to moderate Parkinson's disease.
"These patches are better tolerated by patients because they don't interfere with daily activities and patients don't have to remember to take a pill at a set time each day," says Dr. Koonce.
"For some patients who cannot swallow a capsule, this type of treatment regimen also is effective."
Dr. Koonce's background makes him ideal to treat neuromuscular disorders as well as movement disorders. A former chiropractor, he decided to return to school to become a physician. He graduated from The University Health Sciences College of Osteopathic Medicine in 1995. The College, now called Kansas City University of Medicine and Biosciences College of Osteopathic Medicine, is one of the oldest and largest osteopathic medicine colleges in the nation. He completed a four-year Neurology residency with the U.S. Air Force at Wilford Hall Medical Center, Lackland Air Force Base in San Antonio, TX. He served as a Neurologist at Scott Air Force Base in Illinois for four years, practiced at a hospital in Jefferson City, MO, for two years, and then went into private practice in Wisconsin before coming to Cape Girardeau this year.
"I have an interest in the nervous system and my background as a chiropractor was very helpful as I furthered my studies in neuro-anatomy," says Dr. Koonce. "I'm excited to be here in Cape Girardeau, and I hope to work with primary care physicians in the region to evaluate and help coordinate the care for any of their patients who may have a neurological medical concern."