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Deborah Noonan Hemapheresis Practioner Lead
Conditions Treated with Therapeutic Apheresis
Effectiveness of therapeutic apheresis
Therapeutic apheresis has evolved in its use as a treatment for different conditions and diseases, showing confirmed benefit in many instances. The Spectra Optia® Apheresis System is cleared for therapeutic plasma exchange procedures in the U.S., Canada, Europe, Middle East, Africa and Australia. The COBE® Spectra Apheresis System is cleared for therapeutic apheresis procedures worldwide.
As more study continues into the efficacy of therapeutic apheresis, it helps to understand current indications for use of these procedures. The AABB and the American Society for Apheresis (ASFA) endorse four indication categories to rank the efficacy of therapeutic apheresis for particular conditions or diseases:
Category I: Therapeutic apheresis is considered standard and acceptable as either primary therapy or as valuable first-line adjunct therapy. This doesn't mean that therapeutic apheresis is a mandatory treatment. It just means that when used, it is effective as a primary therapy. Indications that meet this efficacy level are based on well-designed or controlled clinical trials or broad, published cases.
Category II: Therapeutic apheresis is accepted as a supportive or adjunct therapy. It is not a primary first-line therapy.
Category III: Therapeutic apheresis procedures may have benefit, but not enough evidence currently exists to establish benefit or clarify the risk/benefit ratio (and/or the cost/benefit, in some cases). Category III includes diseases and disorders where controlled trials of therapeutic apheresis showed conflicting results. It also includes those cases where anecdotal evidence is small or too variable to develop a consensus view.
Category IV: Controlled trials indicate that there is no benefit from therapeutic apheresis. Anecdotal reports are also discouraging. For disorders and diseases that fall under Category IV, therapeutic apheresis is discouraged, and shouldn't be used except in the context of an IRB-approved research protocol.
Conditions treated with therapeutic apheresis
(Disease and disorder definitions sourced from webmd.com and emedicine.com)
Category I Indications
Goodpasture Syndrome, or anti-glomerular basement membrane antibody disease, is a rare autoimmune disease affecting the lungs and kidney. Though it's unknown why, Goodpasture Syndrome causes an immune response that attacks healthy cells in the lungs and kidneys. Treatment with therapeutic plasma exchange (plasmapheresis) removes the antibodies in the blood that attack the healthy cells.
Thrombotic Thrombocytopenia Purpura, or TTP, is a serious, life-threatening blood disease. Symptoms include severe decreases in the number of platelets carried in the blood, abnormal destruction of red blood cells, nervous system disturbance, fever, and liver dysfunction. Early and aggressive intervention with therapeutic plasma exchange is beneficial. In fact, since the introduction of therapeutic plasma exchange, the survival rate for TTP has risen from 3% to 82%.
Sickle Cell Disease is a group of disorders in which the bone marrow produces red blood cells with defective hemoglobin S. Sickle cell anemia is the most common form of sickle cell disease. It's also the most severe of the sickle cell disorders. As an inherited disorder, people with sickle cell disease have to inherit the gene from both parents to have symptoms of the disease. Sickle cell disease is common in certain populations. In the United States, 1 in 500 African-Americans have the disease. Symptoms of the disease are commonly related to chronic anemia and blood vessel blockage, caused by the rigidity of the deformed red cells. Symptoms include weakness, fatigue, pale appearance, jaundice, shortness of breath, and extreme pain. Red blood cell exchange (RBCX) is used to treat patients during a sickle cell crisis. Some patients receive frequent red blood cell exchange procedures to reduce the incidence of painful and serious complications of the disease, which include stroke, heart damage, and lung infection.
Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP, is a rare neurological disorder that swells nerve roots and destroys the myelin sheath, a protective covering over the nerves. Symptoms include weakness, paralysis, impaired motor function, and sensory loss. Some patients have a slow steady progression of symptoms, while others' symptoms come and go. Therapeutic plasma exchange/plasmapheresis removes the antibodies responsible for the immune-mediated damage of the peripheral nerves.
Guillain-Barre Syndrome is an autoimmune disorder, causing the body's immune system to attack part of the peripheral nervous system. Early symptoms include weakness or tingling in the legs which can spread to the upper body. As the disorder progresses, the symptoms become more intense until a patient is close to complete paralysis. This paralysis is very dangerous because it can interfere with breathing, blood pressure, and heart rate. Therapeutic plasma exchange is effective treatment when used early in the disease because it allows the body to build new antibodies for immunity.
Learn more about any of the procedures discussed here, performed using the Spectra Optia Apheresis System or the COBE Spectra Apheresis System.
Category II Indications
Multiple Myeloma is cancer of the plasma cells. Since most plasma cells live in bone marrow, myeloma usually occurs in major bones of the body. It's called multiple myeloma because it occurs in multiple sites in the bones. Myeloma causes immune system problems from the overproduction of antibodies in plasma cells. Sometimes, myelomas produce an abnormal immunoglobulin called an M protein. If the amount of M proteins in the blood is too high, patients will receive a therapeutic plasma exchange/plasmapheresis procedure to reduce the M proteins.
Lambert-Eaton Myasthenic Syndrome is an autoimmune response that causes gradual muscle weakness, particularly in pelvic and thigh muscles. Approximately 60% of patients with Lambert-Eaton will later develop small cell lung cancer. These patients are generally older patients who smoked for many years. Lambert-Eaton patients without cancer can get the disease at any age. Therapeutic plasma exchange may alleviate symptoms of the disorder.
Learn more about any of the procedures discussed here, performed using the Spectra Optia Apheresis System or the COBE Spectra Apheresis System.
Category III Indications
Systemic Vasculitis causes inflammation of the blood vessels. Because it is systemic, it effects organ systems throughout the body: skin, joints, lungs, kidneys, gastrointestinal tract, blood, sinuses, eyes, brain, and nerves. Symptoms depend on the specific blood vessels involved, but generally patients feel sick, and can experience fevers, weight loss, fatigue, rapid pulse, as well as aches and pains. Experimental therapeutic plasma exchange procedures may help in certain cases of vasculitis.
Systemic Lupus Erythematosus, commonly called lupus, is a very serious autoimmune disorder that causes chronic inflammation of connective tissue. Symptoms include skin rashes, joint pain, and inflammation and damage to the joints, kidneys, skin, tendons, heart, lungs, blood vessels, and brain. TPE is typically only used in patients with rapidly progressing diseases.
Learn more about any of the procedures discussed here, performed using the Spectra Optia Apheresis System or the COBE Spectra Apheresis System.
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