Johnson & Johnson’s Stelara Improves Crohn’s In Two-Year Study
The Janssen Pharmaceutical Companies, part of Johnson & Johnson, presented two-year data from its IM-UNITI trial of Stelara (ustekinumab) in Crohn’s disease. The data was presented at Digestive Disease Week (DDW) in Washington, D.C. over the weekend.
Stelara has been approved for the treatment of Crohn’s disease, plaque psoriasis, and psoriatic arthritis. The drug brings in about $4 billion in annual sales, and recently reported sales growth of 28.9 percent.
Stelara is expected to pick up some of the slack being caused by weakness in J&J’s Remicade, which is also used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis and ulcerative colitis. Since Remicade lost patent protection, sales dropped 16.9 percent to $1.4 billion in the first quarter of 2018.
IM-UNITI is a Phase III, multicenter, randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of Stelara as maintenance therapy in adults with moderate-to-severe Crohn’s disease. Patients who responded to a single IV dose of the drug in the UNITI-1 or UNITI-2 induction trials were split randomly to receive maintenance subcutaneous Stelara 90 mg q8w or q12w, or placebo. Patients who met loss of response criteria between weeks eight and 32 received a one-time dose adjustment to 90 mg q8w. All the patients who made it to week 44 were eligible to enter the long-term extension program, continuing their current regiment to week 92. Patients will continue in the IM-UNITI trial up to week 252.
The two-year data showed that 90 mg of Stelara every 12 weeks and 8 weeks can decrease the risk of Crohn’s disease-related hospitalizations, surgery and the need for alternative biologic treatments compared to placebo. The data indicate that patients in the q8w group were 53 percent less likely to shift to an alternative treatment than the placebo group. The q12w group saw a reduction of risk of 33 percent, but was not found to be statistically significant.
“Crohn’s disease can have a significant impact on patients, with most having multiple relapses and many experiencing complications that require intervention,” said William Sandborn, chief of Gastroenterology at UC San Diego Health System, and study investigator, in a statement. “These long-term data from IM-UNITI are particularly encouraging for clinicians as they demonstrate that treatment with ustekinumab reduced the need for hospitalization, surgery, or a switch to another treatment.”
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract. It is associated with abnormalities of the immune system that are triggered by genetic predisposition, diet or other environmental factors. Symptoms vary, but can include abdominal pain, frequent diarrhea, rectal bleeding, weight loss and fever.
The company stated, “Janssen also presented a new analysis from the UNITI-1 and 2 and IM-UNITI trials assessing which quality of life measures had the greatest impact on health-related quality of life after induction therapy (abstract #2914355). Quality of life impact was measured via a questionnaire. At the start of the trials factors such as fatigue, sleep, loose stools and emotional and social effects such as feeling unwell and impact on leisure activity were seen to have the great negative impact on quality of life, with mean scores of <3.5 By week 8 significant improvements were seen for these measures in patients receiving ustekinumab versus placebo.”