Janssen-Cilag International reported results from its ongoing IM-UNITI long-term extension (LTE) clinical trial assessing the efficacy and safety of subcutaneous (SC) Stelara (ustekinumab) in patients with moderate to severe Crohn’s disease.
The company, a division of Johnson & Johnson, presented the study’s two-year results at the 12th Congress of the European Crohn’s and Colitis Organisation, and demonstrated that patients treated with Stelara maintained clinical response and remission for up to two years.
“Maintaining control of disease symptoms is paramount in the treatment of Crohn’s disease,” William Sandborn, MD, chief of gastroenterology at University of California-San Diego Health System, said in a press release. “The two-year clinical response and remission rates from the IM-UNITI study provide further evidence that ustekinumab can be an effective therapeutic option for people living with this chronic and often debilitating disease.”
The IM-UNITI maintenance study (NCT01369355) evaluated patients who achieved clinical response eight weeks after a single intravenous infusion of Stelara in two Phase 3 trials: UNITI-1 (NCT01369329) and UNITI-2 (NCT01369342). More than half of patients receiving Stelara by injection every eight weeks were in clinical remission after almost one year of treatment.
The study’s primary endpoint was clinical remission at week 44, defined by a Crohn’s Disease Activity Index score of less than 150 points.
Secondary endpoints included clinical response, clinical remission among patients in remission after induction, corticosteroid-free remission and clinical remission in patients refractory or intolerant to anti-TNF-alpha therapies.
Of the 1,281 patients enrolled, 397 patients who achieved a response at eight weeks following an induction phase were randomized to Stelara 90 mg SC every eight weeks, Stelara 90 mg SC every 12 weeks, or placebo.
Efficacy data were collected every 12 weeks and safety data were collected every four weeks from the end of the maintenance trial (week 44). Data was then collected at every eight weeks or every 12 weeks during the LTE period (44–252 weeks).
The data presented during the meeting refer to week 92. Of patients enrolled in the LTE period and who continued treatment with Stelara through week 96, 79.2 percent of patients treated with Stelara every 12 weeks were in clinical remission, compared to 87.1 percent of patients receiving Stelara every eight weeks. Clinical response was observed in 90.9 percent of patients and 94.3 percent of patients, respectively.
Among Stelara-treated patients who continued the treatment through week 96, the remission rate at week 92 was 70.2 percent, and the response rate was 84.7 percent.
During the treatment period (weeks 44-96), two patients being treated with Stelara died. One Stelar-treated patient developed testicular cancer, and one placebo-treated patient developed a papillary thyroid cancer.
“The 96-week data from the IM-UNITI study complement data previously presented from the UNITI program,” said Frederic Lavie, EMEA therapeutic area leader for immunology, cardiovascular and metabolics at Janssen. “We look forward to sharing future results from the UNITI program, and remain committed to improving overall outcomes for people living with Crohn’s disease.”
Stelara (ustekinumab) was approved in September 2016 by the U.S. Food and Drug Administration and two months later by the European Commission for the treatment of adults with moderate-to-severe active Crohn’s disease. It is the first approved biologic treatment for Crohn’s that targets interleukin (IL)-12 and IL-23 cytokines, both of which are known to play a critical role in immune and inflammatory responses.
Doctors may prescribe Stelara only to patients who either fail completion or cannot tolerate treatment with immunomodulators or corticosteroids, but who never failed treatment with tumor necrosis factor (TNF) blockers — or those who failed completion or were intolerant to treatment with one or more TNF blockers.