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Statement: The North
Carolina Rheumatology Association believes that the
use of biologic agents (infliximab, etanercept, anakinra,
adulimumab, abatacept, and rituximab) for the treatment
of patients with serious autoimmune diseases (e.g. psoriatic
arthritis, ankylosing spondylitis, inflammatory eye
disease, Behcet's disease, and possibly other autoimmune
inflammatory illnesses) is appropriate in those who
do not respond to other therapies or are not candidates
for other therapies available and is the standard of
care when patholophysiologic evidence and published
information for efficacy exists and supports the use
of these agents. Interfering with the prudent, reasonable
and cautious treatment of patients represents an interference
with the standard of care for patients in need of serious
disease treatment in a timely manner These treatments
should be quickly approved and available through health
insurers when a rheumatologist has concluded that treatments
with these agents are necessary.
Discussion: In the
last decade, increased knowledge of cytokine activation
and interactions has lead to a better understanding
of the pathogenesis of rheumatoid arthritis, psoriatic
arthritis, and other autoimmune inflammatory diseases.
As a result of these discoveries and the development
of biologic agents to inhibit cytokine and other protein
activities, a marked improvement in disease control
and prevention of progression is now possible in many
patients. FDA approval of these and other medications
for specific indications are recognized as guidelines
for the pharmaceutical industry and are not intended
to restrict medical use where appropriate. Pathophysiologic
mechanisms in other serious, uncommon and rare diseases
warrant use of these agents especially where academic
experience, published information and/or scientific
information is confirmatory.
For example, infliximab, etanercept,
and adalimumab are biologic agents targeting tumor necrosis
factor, a key cytokine in immune mediated inflammatory
diseases. The FDA has approved these agents for use
in the treatment of rheumatoid arthritis, psoriatic
arthritis and ankylosing spondylitis. Other indications
are pending FDA approval. These medications have been
shown in numerous clinical studies, as published in
scientific journals and at scientific meetings, to have
a dramatic impact on the activity of many other disease
states not responsive to other therapies including inflammatory
eye disease, Reiter's syndrome, dermatomyositis, and
Behcet's syndrome. Improvement in joint, skin and destructive
organ involvement is observed in these respective diseases.
Improvement in short-term disease activity with preservation
of function, low risk and long-term quality of life
(potentially resulting in less disability, decreased
need for joint replacement surgery, decreased skin scarring,
preservation of vision and probably decreased mortality
due to other disease complications and comorbid conditions)
are possible with these treatments (references available
upon request).
Biologic agents need to be available
when therapeutic alternatives for the treatment of inflammatory
eye disease, Behcet's disease, and other autoimmune
diseases fail or are not indicated. For example, infliximab
has been shown in many clinical studies to have significant
benefit in inflammatory eye disease, Behcet's disease,
and other autoimmune diseases.
A rheumatologist, along with
patient input, must consider a patient's age, gender,
length and severity of illness, potential complications
of alternate therapies, comorbid conditions and other
medical history in determining the appropriate medication
for management. To abrogate or impair this decision
making capacity of rheumatologists is indicative of
a denial to accept the standard of care as set forth
by the North Carolina Rheumatology Association.
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