Home Front Page Stelara succeeds in phase 3 Crohn’s disease trial

Stelara succeeds in phase 3 Crohn’s disease trial

Johnson & Johnson's Stelara drug looks set to be approved for treating Crohn's disease after a successful stage 3 trial. If so, it will become one of the few approved treatments for Crohn's.

Johnson & Johnson’s drug Stelara, which is designed to treat Crohn’s disease, has shown promising results in its stage three trials. Compared to placebos, Stelara delivered big results in terms of both a positive response, and lowering remission.

Crohn’s disease is non-life threatening chronic inflammatory bowel disease that is believed to affect more than 1 million Americans. Most of those diagnosed with the disease are relatively young, usually between the age of 15 and 30.

There is no cure for Crohn’s disease, which is caused by unknown factors. Symptoms include diarrhea, bloody stools, abdominal pains, and other disturbances in bowel movements.

Stelara is already a big revenue producer for Johnson & Johnson producing over $600 million dollars in the third quarter alone. The drug is an anti-inflammatory drug and is approved to treat scaly plaque psoriasis and a specific type of arthritis associated with psoriasis.

Patients not given the placebo were given only one infusion of Stelara, either a 130 mg dose, or a 6 mg per kilogram dose. The patients were then monitored over the course of six weeks. 52 percent of those who were given 130 mg doses and 55 percent given the per weight dose, reported a clinical response. Only 29 percent of those who took the placebo reported the same.

A clinical response is defined as a reduction in the Crohn’s Disease Activity Index.

Remission data showed similar results. 31 percent of the 130 MG group and 40 percent of the per weight group demonstrated remission by the 8th week of the study. Only 20 percent of those given a placebo reported remission. 628 patients participated in the study.

So will Stelara ultimately be approved as a treatment for Crohn’s disease? A co-investigator of the drug, Dr. Brian Feagan, stated “I think this is an approvable drug.”

The results were presented on Monday at the American College of Gastroenterology meeting in Honolulu, Hawaii.