This new analysis of long-term data from the ongoing Phase 3 IM-UNITI extension trial (NCT01369355) was presented at the 2018 Digestive Disease Week meeting, recently held in Washington, D.C. The abstract was titled “Reduced rates of Crohn’s- related surgeries, hospitalizations and alternate biologic initiation with ustekinumab in the IM-UNITI study through 2 years.”
“Crohn’s disease can have a significant impact on patients, with most having multiple relapses and many experiencing complications that require intervention. These long-term data from IM-UNITI are particularly encouraging for clinicians as they demonstrate that treatment with ustekinumab [Stelara] reduced the need for hospitalisation, surgery, or a switch to another treatment,” William Sandborn, MD, gastroenterology chief at UC San Diego Health System and a study investigator, said in a press release.
IM-UNITI, a randomized, double-blind, placebo-controlled, parallel group study, evaluated the effectiveness and safety of Stelara maintenance therapy in 1,282 adult patients with moderate to severe Crohn’s disease at 220 centers worldwide.
Patients who had responded to a single dose of Stelara in the UNITI-1 (NCT01369329) or UNITI-2 (NCT01369342) induction studies were randomized to three groups, receiving either a maintenance dose of 90 mg every eight weeks, or every 12 weeks, or a placebo.
Patients who responded well to the treatment at week 44 of the IM-UNITI trial could enter the long-term extension part of the study, currently ongoing, up to 252 weeks. Completion of the study is expected in October 2019.
This most recent analysis showed that patients receiving Stelara every 12 weeks were 52% less likely to be admitted to a hospital or require surgery, compared with the placebo groups. Patients receiving Stelara every eight weeks were 40% less likely to be hospitalized or require surgery. Moreover, patients receiving Stelara every eight weeks were 53% less likely to switch to treatment with another biologic than the placebo group.
The most common adverse reactions reported in trials testing Stelara in patients with adult psoriasis, psoriatic arthritis, and Crohn’s disease, as well as in post-marketing experience, were upper respiratory tract infection, joint pain, back pain, diarrhea, dizziness, fatigue, headache, injection site pain, injection site swelling, muscle pain, colds, nausea, throat pain, itching, and vomiting.
In another presentation at Digestive Disease Week, titled “Post hoc analysis of the impact of ustekinumab treatment on specific items of the inflammatory bowel disease questionnaire in the UNITI-1&2 programs,” Janssen presented an analysis from the three trials about Stelara’s impact on quality of life, gathered from patient questionnaires.
Data showed that at the beginning of the trials, fatigue, sleep, emotional and social effects, and loose stools had the greatest impact on quality of life. Significant improvements were seen in these factors in patients receiving Stelara versus placebo by the eighth week.
Previous results from the IM-UNITI trial showed that of the patients who entered the long-term extension study and who continued treatment with Stelara through week 96, 79.2% treated with Stelara every 12 weeks were in clinical remission, compared with 87.1% who received Stelara every eight weeks.
In 2016, the U.S. Food and Drug Administration and the European Commission approved Stelara for the treatment of adult patients with moderate to severe Crohn’s disease who do not respond to conventional therapy or TNF-alpha antagonists, do not tolerate them, or if there are contraindications for their use. Additionally, in the U.S., Stelara may be prescribed to patients who have not failed treatment with a TNF blocker.