Hope for Crohn's Patients with Fistulas found in HUMIRA/Adalimumab

At the recent European Crohn's and Colitis Organization (ECCO) annual meeting in Lyon, France, Abbott Laboratories announced that HUMIRA (Adalimumab) is successful in the treatment of fistulas in susceptible Crohn's patients.

Crohn's Disease (CD) is a gastrointestinal disorder which is indicated by chronic inflammation of the wall of the digestive tract. The disease involves constant cycles of flare-ups and remission throughout the life of the patient, and without proper treatment, must be addressed surgically. It is considered an inflammatory bowel disease (IBD), similar to ulcerative colitis. Up to 43% of Crohn's disease patients develop painful and embarrassing fistulas, which are tunnels that connect affected organs to surrounding tissues such as the bladder, vagina, or skin. These are difficult to treat, can cause fecal discharge in abnormal locations, and can thus lead to incontinence, infections, and complications that will necessitate surgery.

HUMIRA, or Adalimumab works by binding Tumor Necrosis Factor α (TNF-α), an important part of the immune response pathway -- in this way it is related to infliximab and other TNF-α blockers. It has been approved in several countries for treatment of many autoimmune diseases including CD, psoriasis, and certain types of arthritis. Abbott Labs is also studying HUMIRA in pediatric CD.

The fistula study was based on data taken in the CHARM study. In a subanalysis, it was shown that fistula healing was improved with treatment with HUMIRA:

* 60% of patients experienced fistula healing at one year of treatment
* 76% of patients who experienced healing at one year sustained the healing through two years
* 71% of patients demonstrated a 50% reduction in the number of draining fistulas after two years of treatment

Over a two year term, fistula patients had a higher quality of life because the CD was in remission, defined as scoring greater than 170 points on the Inflammatory Bowel Disease Questionnaire (IBDQ): after 1 year, 54% of patients and after 2 years, 60% of patients achieved this score.

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