(Reuters) – More than half of patients taking the tumor necrosis factor alpha inhibitor golimumab (Simponi, Johnson & Johnson) for moderate to severe ulcerative colitis showed a significant improvement in symptoms and bowel healing, according to data from a late-stage clinical trial.
Patients taking the drug in the trial showed highly statistically significant improvements in clinical response at six weeks, as well as clinical remission and bowel healing compared with placebo, meeting the study’s primary and secondary goals.
“I think this will be very welcomed by physicians and patients,” said Dr. William Sandborn, the study’s lead investigator, noting that more treatment options are needed for the disease.
Dr. Sandborn, who called the data “quite exciting,” presented the results on Monday at the Digestive Disease Week meeting in San Diego.
The study tested two dosing levels of golimumab against a placebo. The patients had either failed to respond to, or could not tolerate, other conventional therapies such as steroids.
The formulation of golimumab tested in the phase III study is a self-administered subcutaneous injection, making it potentially much more convenient for patients than infliximab (Remicade, Johnson & Johnson), which is administered intravenously.
Patients received either 200 mg of golimumab at the start of the study and 100 mg at week two; 400 mg of golimumab to start and 200 mg at week two; or a placebo.
After six weeks, 55% of those who got the higher dose and 52% who received the lower dose showed a clinical response, compared with 29.7% of placebo patients.
Clinical response was defined as a decrease of at least 30% and 3 points on the 12-point Mayo scale used to assess disease activity, and a significant decrease in rectal bleeding.
About three times as many patients who got golimumab, achieved clinical remission at six weeks as those in the placebo group. Remission was defined as a Mayo score of 2 points or less. Patients began the study with a score of 6 to 12 on the Mayo scale.
The remission rate was 18.7% on the lower dose of golimumab, 17.8% for the higher dose and 6.3% for placebo, researchers said.
Maintenance study results (after a year on the drug) are expected to be available later this year, Dr. Sandborn said.
Nearly one-half of all golimumab patients also experienced significant bowel improvement, or mucosal healing, revealed through endoscopic examination — 45.3% on the high dose and 43.2% on the lower dose. That compared with 28.5% in the placebo group.
Side effects were similar in the drug and placebo groups in the six-week study, researchers said.
One patient experienced a reversible neurologic event similar to multiple sclerosis that Dr. Sandborn said was not surprising with this class of drug. One patient in the study died, the company said. Dr. Sandborn said the safety profile would become much clearer once the one-year maintenance study results were available.