Statement: The North Carolina Rheumatology Association believes that the standard of care for the administration of biologic agents for autoimmune inflammatory rheumatic diseases requires rheumatologist recommendations for the choice of medication as well as rheumatologist approval of the handling, delivery, storage and administration of parenterally administered medications when infusions are performed in their offices.

Discussion: In the last decade there have been numerous discoveries that have lead to a better understanding of the pathogenesis of rheumatoid arthritis as well as other autoimmune inflammatory diseases. As a result of these discoveries, agents that modify or inhibit specific proteins involved in the immune response, termed biologic agents, have been developed. The use of these agents in the treatment of rheumatoid arthritis and other autoimmune diseases has resulted in a marked reduction in tissue destruction with a resultant improvement in the functional status and general health of people with these illnesses. According to some studies it is now possible to even prevent deformities and disabilities in illnesses like rheumatoid arthritis.

Biologic agents target specific elements of the immune system involved in disease pathogenesis and inflammation. For the treatment of rheumatoid arthritis the FDA has approved the use of infliximab, etanercept, anakinra, adulimumab, rituximab, and abatacept. These medications have been shown, in clinical trials, to have a dramatic impact on disease activity by reducing joint swelling, pain, and stiffness. Several of these medications have additionally been shown to reduce joint erosions and joint space narrowing which lead to joint destruction, deformities and disability. Use of these agents not only improves short-term disease activity and symptoms but also improves long-term outcomes by preserving quality of life, decreasing disability and avoiding the need for joint replacement surgery and perhaps even long term care.

There are many therapeutic alternatives for the treatment of rheumatoid arthritis. A rheumatologist, with patient involvement, must consider age, gender, length and severity of illness, and other medical history in determining the appropriate medication for that specific patient. The North Carolina Rheumatology Association believes that the choice of biologic agents for the treatment of rheumatoid arthritis is the responsibility of the treating rheumatologist and the patient based on standard of care issues. Additionally, in-office infusion of pareneteral biologic agents is extremely safe and highly cost-effective in the hands of rheumatologists. This is similar to the current policies established for physicians specializing in Oncology, who have been utilizing in-office infusions and injections of chemotherapy agents for many years.

These medications require appropriate handling, delivery as well as careful inventory management. Without appropriate refrigeration and handling, these medications can be denatured or damaged. If denatured, more serious side effects may occur during infusion or administration. It is therefore imperative that the delivery of these medications also remains acceptable to established standards of care for biologic agents. This is of extreme importance in biologic agents requiring intravenous infusion.

The intravenous infusions of biologic agents can be associated with potentially serious side effects, including: pruritus, rash, fever, headache, dyspnea, chest pain, hypertension, hypotension and even anaphylactic reactions. It is imperative that these medications be given in a controlled environment with experienced staff present who are also knowledgeable of the patient's complicated medical history, aware of the potential side effects of the infused biologic agents and competent in the management of potential adverse events. Under these conditions, patient acceptance and confidence is increased, compliance is assured, outcomes are optimized and efficiency is maximized.