Investigating new drug for Chron’s disease

Investigating new drug for Chron’s disease

Researchers are investigating a new drug to treat Crohn’s disease. Ustekinumab, a monoclonal antibody, is an immunosuppressant that had positive results in studies performed so far by researchers at the University of California at San Diego, School of Medicine. The study was published in The New England Journal of Medicine.

IBD (Crohn’s disease and ulcerative colitis) are chronic inflammatory diseases of the gastrointestinal tract that is manifested by abdominal pain, diarrhea, intestinal bleeding, weight loss, loss of appetite, fever etc. There may be extra-intestinal manifestations such as uveitis, arthralgia, erythema nodosum, etc.. Symptoms affect patients throughout life with periods of remission and periods of attack. The difference between these two diseases is made by intestinal mucosa biopsy and histopathology. Crohn’s disease is affecting discontinuously the intestinal  mucosa with segments of normal mucosa (transmural lesions) between lesions (cobblesstone) while ulcerative colitis is characterized by lesions strictly limited to the mucosa.

It should be noted that medical treatment of these diseases differs according to the stage of disease. Surgery is indicated especially when complications arise: fistulas, fissures, obstruction. Medical treatment includes salicylic acid derivatives (5 aminosalicylic), corticosteroids, immunomodulators (methotrexate, azathioprine, cyclosporine), biological agents (infliximab), antibiotics etc. Besides being a chronic disease that affects the quality of life of patients, Crohn’s disease is not always easy to treat. There are patients who do not respond or respond well to treatment initially and then have to change treatment because it is not effective.
Now researchers at the University of California at San Diego, School of Medicine investigate a new drug to control symptoms of Crohn’s disease. So far the results show that Ustekinumab increased clinical response and remission in patients with moderate to severe Crohn’s disease. Sanborn, MD, principal investigator and chief of the Division of Gastroenterology at the UC San Diego School of Medicine, said that it is a big challenge to treat patients who are resistant to inhibitors of TNF (tumor necrosis factor) such as Humira, Remicade etc.
The researchers made a randomized placebo-controlled that included five hundred and twenty-six patients from 12 countries. Study duration was 36 weeks and clinical outcomes were observed after 6 weeks. Now this drug will be tested in a phase 3 clinical trial to confirm the results. It should be noted however that Ustekinumab has significant side effects. As an immunosuppressant, this drug can give severe infections and even certain cancers. 5 patients included in the study had severe infections and one developed basal cell carcinoma.
Ustekinumab is an immunosuppressant that blocks inflammation by inhibiting two proteins (IL 12 and IL 23). Ustekinumab has been approved by the FDA for the treatment of psoriasis.