Two clinical trials of Humira ( Adalimumab ), REVEAL and CHAMPION, have demonstrated promising results in psoriasis.

Psoriasis is a chronic autoimmune disease that speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis appears as red, raised areas of skin covered with flaky white scales, which may itch or burn. Psoriasis most commonly appears on the scalp, knees, elbows, lower back, hands and feet, though it can develop anywhere on the skin. It may even occur in the fingernails, toenails and in the joints. While psoriasis can occur in people of all ages, it typically appears in patients between the ages of 15 and 35. The severity of the disease varies from person to person. Currently, there is no cure for psoriasis.

In REVEAL, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of Humira were evaluated in more than 1,200 patients from the United States and Canada with moderate to severe chronic plaque psoriasis.
Patients experienced a significant reduction in the signs of their disease at 16 weeks when treated with Humira; specifically, almost three out of four patients ( 71 percent ) receiving Humira achieved PASI 75 or better, compared to only 6.5 percent of patients receiving placebo.
One in five ( 20 percent ) patients receiving Humira achieved PASI 100 ( complete clearance ), compared to less than 1 percent of patients receiving placebo.

In CHAMPION, a 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, twice the percentage ( 80 percent ) of patients treated with Humira achieved PASI 75 compared to patients treated with Methotrexate ( 36 percent ), a standard systemic treatment for psoriasis, and four times more than patients treated with placebo ( 19 percent ).
Nearly 17 percent of patients treated with Humira achieved PASI 100 at week 16, compared to 7 percent of patients receiving Methotrexate and 2 percent of patients receiving placebo.
In addition, a mean PASI improvement of 57 percent was achieved at week four in patients receiving Humira, compared to baseline.

The adverse events observed in REVEAL and CHAMPION were similar to those observed in previous Humira studies. The most commonly reported adverse events in Humira psoriasis trials were upper respiratory tract infection, nasopharyngitis and headache.

Serious infections, sepsis, tuberculosis and rare cases of opportunistic infections, including fatalities, have been reported with the use of TNF-blocking agents, including Humira. Many of these serious infections have occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections.
Treatment with Humira should not be initiated in patients with active infections.
TNF-blocking agents, including Humira, have been associated with reactivation of hepatitis B ( HBV ) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infections should be evaluated for prior evidence of HBV infections before initiating Humira. The combination of Humira and Anakinra ( Kineret ) is not recommended.

TNF-blocking agents, including Humira, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents. More cases of malignancies have been observed among patients receiving TNF blockers, including Humira, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately four fold higher rate of lymphoma in combined controlled and uncontrolled open-label portions of Humira clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known.

Worsening congestive heart failure ( CHF ) has been observed with TNF-blocking agents, including Humira, and new onset CHF has been reported with TNF-blocking agents. Treatment with Humira may result in the formation of autoantibodies and rarely, in development of a lupus-like syndrome.

The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis ( Humira vs. placebo ) were injection site reactions ( 20 percent vs. 14 percent ), upper respiratory infection ( 17 percent vs. 13 percent ), injection site pain ( 12 percent vs. 12 percent ), headache ( 12 percent vs. 8 percent ), rash ( 12 percent vs. 6 percent ) and sinusitis ( 11 percent vs. 9 percent ).

Discontinuations due to adverse events were 7 percent for Humira and 4 percent for placebo. As with any treatment program, the benefits and risks of Humira should be carefully considered before initiating therapy.

Humira is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in the United States and Europe.

Source: Abbott, 2007


XagenaMedicine2007


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