Patients with ulcerative colitis respond to Simponi, study finds

J&J releases results of phase-3 trial

SAN DIEGO — Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.

Johnson & Johnson subsidiary Janssen Research and Development announced results of a phase-3 trial of Simponi (golimumab) in ulcerative colitis patients whose condition had previously failed to improve with or who were intolerant to conventional drugs.

In one treatment group, patients received 200 mg of the drug subcutaneously at week zero and 100 mg at week two, while in another they received 400 mg at week zero and 200 mg at week two. A third group received placebo. Results indicated that 51.8% of patients in the first group responded to treatment after six weeks, compared with 55% in the second group and 29.7% in the placebo group.

"Therapeutic options for patients living with moderate to severe forms of ulcerative colitis who have failed or become intolerant to conventional treatments are quite limited today, which is particularly challenging in managing a disease that primarily affects a younger, active patient population," study investigator and University of California San Diego School of Medicine professor William Sandborn said.


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