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Abbott's Humira (Adalimumab) Shows Promising Results in Long-Term Treatment of Crohn's Disease, According to Phase III Study

Approximately Three-Fourths of Study Patients Taking Humira Every Other Week Maintained Clinical Remission After 1 Year

ABBOTT PARK, IL -- October 31, 2005 -- Data from an analysis of 55 patients with moderate to severely active Crohn's disease who achieved clinical remission through treatment with Humira(R) (adalimumab) show 74% of patients maintained clinical remission through continued treatment with Humira every other week (EOW) for 1 year.

Eighty-three percent of patients on Humira every week maintained clinical remission for one year, according to results from a Phase III extension study being presented this week at the American College of Gastroenterology (ACG) annual meeting.

Maintaining Clinical Remission
Patients in the study had completed participation in CLASSIC I (CLinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's), a randomized, double-blind, placebo-controlled, multi-center study designed to determine the efficacy and safety of Humira for inducing clinical remission in patients with moderate to severe Crohn's disease.

At the conclusion of the 4-week study, patients were eligible to enroll in CLASSIC II, the extension study designed to evaluate Humira's ability to maintain clinical remission. All patients in CLASSIC II received 40 mg of Humira at weeks 0 and 2. Depending on their clinical remission status at weeks 0 and 4, patients were assigned to one of two cohorts: randomized or open-label.

The 55 patients who were in clinical remission at both week zero and week four were assigned to the randomized cohort, where they received either 40 mg Humira every week (n=18), 40 mg Humira every other week (n=19) or placebo (n=18). At 1 year, 83% of patients taking Humira weekly maintained clinical remission vs. 44% for placebo (P <.05). Of patients taking Humira EOW, 74% maintained clinical remission vs. 44% placebo (P = ns). Clinical remission is defined as a Crohn's Disease Activity Index (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.

"There is no cure for Crohn's disease and the immediate goal of treatment is to suppress the inflammatory response in order to allow intestinal tissue to heal. The next critical step is maintaining clinical remission, thereby preventing disease flares that may disrupt patients' lives," said William J. Sandborn, MD, Inflammatory Bowel Disease Clinic, Division of Gastroenterology and Hepatology, Mayo Clinic and Mayo Medical School, Rochester, Minn. "The new adalimumab (Humira) data is promising for the hundreds of thousands of patients suffering from moderate to severe Crohn's disease."

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. Seventy-five percent of people with the disease may require surgery at some time.

"Crohn's disease flares can cause an immediate, urgent need to go to the bathroom, making it necessary for many of these patients to plan activities based on the nearest restroom," said Rodger DeRose, president and CEO, Crohn's and Colitis Foundation of America. "Finding an effective treatment that helps to keep the disease in clinical remission may allow many Crohn's patients to gain more control of their daily lives."

Additional Open-Label CLASSIC II Results
The remaining 221 patients who were not in clinical remission at both week 0 and week 4 of the CLASSIC II study were assigned to an open-label cohort, in which they were given a standard dose of 40 mg of Humira every other week. Patients experiencing flares or persistent non-response to the standard dose were given 40 mg of Humira every week. Of the 221 patients entering this cohort, at 1 year nearly half (43%) achieved clinical remission. Furthermore, more than two-thirds (69%) of the patients in the open-label cohort achieved a clinical response, with a decline in CDAI of at least 70 points, and 61% achieved a CDAI decline of at least 100 points, compared to their baseline CDAI scores.

The adverse events in either CLASSIC II cohort were mild to moderate in severity and, with the exception of Crohn's disease-specific events, were similar to those observed in previous studies with patients with rheumatoid arthritis (RA). The most common serious adverse events were exacerbations of Crohn's disease and infections.

"Humira was developed as a treatment for rheumatoid arthritis and was recently approved for psoriatic arthritis," said Peter Isakson, Ph.D. and divisional vice president, immunology research at Abbott Bioresearch Center (ABC) where Humira was discovered and developed. "One-year data in Crohn's reinforces the promise of Humira as a potential treatment for this chronic disease. This is an example of Abbott's commitment to novel treatments for serious conditions. ABC is at the forefront of research in inflammatory diseases and continues to discover antibodies and small molecules that address unmet medical needs in this area."

Important Safety Information
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. Treatment with Humira should not be initiated in patients with active infections. The combination of Humira and anakinra 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.

The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (Humira vs. placebo) were injection site reactions (20% vs. 14%), upper respiratory infection (17% vs. 13%), injection site pain (12% vs. 12%), headache (12% vs. 8%), rash (12% vs. 6%) and sinusitis (11% vs. 9%). Discontinuations due to adverse events were 7% for Humira and 4% for placebo. As with any treatment program, the benefits and risks of Humira should be carefully considered before initiating therapy.

The safety profile for patients with psoriatic arthritis treated with Humira in the clinical trials has been similar to the safety profile seen in patients with RA.

About Humira
Humira is the only fully human monoclonal antibody approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Humira can be used alone or in combination with methotrexate (MTX) or other DMARDS (disease-modifying anti-rheumatic drugs).

Humira is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis. Humira can be used alone or in combination with DMARDS.

To date, Humira has been approved in 63 countries and prescribed to more than 110,000 patients worldwide. Clinical trials are currently underway evaluating the potential of Humira in other autoimmune diseases.


SOURCE: Abbott

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