A Phase III study showed that patients with moderate to severely active Crohn's disease treated with Adalimumab ( Humira ) have seen continuing improvements in clinical response and clinical remission.

After 24 weeks, an improvement in disease response, as measured by a decrease of more than 70 points from baseline in their Crohn's Disease Activity Index ( CDAI ), was observed in the 78 percent of patients who completed open label treatment.
Of the 220 patients enrolled in the trial, one in three ( 33 percent ) achieved clinical remission, defined as CDAI of less than 150.

CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, level of general well-being and other measures.

" Crohn's disease is a serious and often disabling illness. The fact that 75 percent of people with the disease will at some time require surgery indicates the importance of finding treatments that may induce sustained response and remission," said William J. Sandborn, of Mayo Clinic and Mayo Medical School, Rochester " These new data are promising because patients not only showed clinically meaningful improvement during the six- month study, but their response continued to improve over time. "

Crohn's disease is a serious chronic and inflammatory disease of the gastrointestinal ( GI ) tract that affects approximately 500,000 Americans and is typically diagnosed before age 30.
Common symptoms of the disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding.

CLASSIC II ( CLinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's ) was an extension of the CLASSIC study, a randomized, double-blind, placebo-controlled, multi-center study.
CLASSIC II was designed to evaluate long-term efficacy and safety of Humira in patients with moderate to severely active Crohn's disease.

The trial included 220 patients who had participated in the original CLASSIC study but were not in remission at week 0 and week 4.
The standard dose for this cohort was open-label treatment with 40 mg of Adalimumab every other week ( eow ), the same recommended dose used for Humira in rheumatoid arthritis.
Patients experiencing flares or persistent non-response to the standard dose were given 40 mg of Adalimumab every week.

Of the 220 patients entering the study, 33 percent achieved clinical remission.
Of the 156 patients completing 24 weeks of therapy, 78 percent achieved a response, with a decline in CDAI of at least 70 points, and 70 percent achieved a CDAI decline of at least 100 points, compared to their baseline CDAI scores in CLASSIC.

The adverse events in the study were mild to moderate in severity and similar to those observed in previous studies with patients with rheumatoid arthritis.
The most common serious adverse events were exacerbations of Crohn's disease and infections.

Cases of tuberculosis ( TB ) have been observed in patients receiving Humira. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including Humira. Many of these infections occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. 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 and rare reports of lymphoma have been reported with TNF-blocking agents. Patients with rheumatoid arthritis, particularly those with highly active disease are at a higher risk for the development of lymphoma.
The potential role of TNF-blocking therapy in the development of malignancies is not known.

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.

Humira is the only fully human monoclonal antibody approved by the FDA for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis ( RA ) who have had an inadequate response to one or more disease-modifying antirheumatic drugs ( DMARDs ).

. Source: Digestive Disease Week ( DDW ), 2005


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