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HUMIRA
FDA Approves New Therapy for Rheumatoid Arthritis
FDA has approved adalimumab (marketed by Abbott Laboratories as HUMIRA) to treat
rheumatoid arthritis (RA). This is the second treatment of its kind and may significantly
increase the availability of these therapeutics to patients.
HUMIRA is produced by recombinant DNA technology.
It is a human-derived antibody that binds to human tumor necrosis factor alpha (TNF
alpha). TNF is naturally produced by the body and is involved with normal inflammatory and
immune responses. Individuals with rheumatoid arthritis, a disease that affects more than
2 million Americans, have high levels of TNF in the synovial fluid (lubricating fluid in
joints). The extra TNF plays an important role in both the pathologic inflammation and the
joint destruction that are hallmarks of RA.
By working against the inflammatory process, HUMIRA, like other TNF blockers has been
shown to be effective in controlling symptoms of the disease. HUMIRA is indicated for
reducing signs and symptoms and inhibiting the progression of structural damage in adult
patients with moderately to severely active rheumatoid arthritis who have had an
inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA
can be used alone or in combination with methotrexate or other DMARDs.
The efficacy and safety of HUMIRA were assessed in four randomized, double-blind
studies in adult patients. HUMIRA was found to reduce signs and symptoms of rheumatoid
arthritis in over half the patients. In one of the four studies, patients were treated for
a year and then evaluated radiographically. Patients treated with HUMIRA plus methotrexate
(MTX) demonstrated less joint deterioration than patients receiving MTX alone.
HUMIRA is administered as a single subcutaneous injection every other week.
The package insert carries a bolded warning stating that serious, sometimes fatal,
infections (including cases of tuberculosis and sepsis) have been reported with the use of
TNF-blocking agents including HUMIRA. The most serious adverse events associated with
HUMIRA are, as with other TNF blockers, serious infections, neurologic effects, and
certain malignancies of the lymphoid system. A higher rate of lymphomas was observed than
the expected rate in the general population, but RA patients, particularly those with
active disease, may be at a higher risk for development of lymphoma. Patients with
rheumatoid arthritis should discuss therapy options with their healthcare providers.
HUMIRA is administered as a single subcutaneous injection every other week.
The FDA’s Center for Biologics Evaluation and Research was able to approve this
treatment ahead of deadline, reviewing the product within nine months (standard review is
a ten-month cycle). |
