Results of Stelara Phase 3 Trial for Crohn's Disease Announced
Janssen announced positive results from its UNITI-1 Phase 3 trial of Stelara, for the treatment of moderate-to-severe Crohn's disease. Stelara demonstrated significantly higher rates of clinical response at week 6 over placebo in patients who'd previously shown intolerability to treatment with at least 1 anti-TNF-alpha therapy.
A total of 741 patients participated in the UNITI-1 trial, with each receiving either a placebo, Stelara 130mg or Stelara ~6mg/kg (dosing was weight-tiered), intravenously.
At week 6, 34% of those receiving Stelara 130mg and Stelara ~6mg/kg, achieved a reduction in baseline of the Crohn's Disease Activity Index (CDAI) over 100 points. Twenty-one percent of the placebo group reduced their CDAI score by over 100. At week 8 the score remained the same for the 130mg group, and improved for the ~6mg/kg group, with 38% registering scores of over 100 for the CDAI. The placebo groups scores decreased slightly to 20%.
The researchers found that 16 and 21% of those receiving Stelara, 130mg and ~6mg/kg respectively, achieved clinical remission. Remission was defined as a CDAI score of less than 150 points. No serious adverse events occurred during the trial, though possible known adverse events related to Stelara treatment includes serious infection, cancers due to lowered immune activity, reversible leukoencephalopathy syndrome and serious allergic reactions.
At week 8, patients either transitioned to a maintenance study (IM-UNITI ) or were to complete a safety follow-up period through week 20. Janssen expects to announce results from the IM-UNITI maintenance study at a future medical congress. Stelara is a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, including Crohn's disease. Stelara is currently approved in the U.S. to treat adults with moderate to severe plaque psoriasis and psoriatic arthritis, alone or in combination with methotraxate (MTX).
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