J&J’s Biologic Therapy Stelara Helps Crohn’s, Ulcerative Colitis

Johnson & Johnson recently announced efficacy and safety data for its biologic therapy, Stelara (ustekinumab) in treating patients with Crohn’s disease and ulcerative colitis.

The company’ SEAVUE study was the first head-to-head study of biologic therapies in patients with Crohn’s disease. The study enrolled 386 patients with moderately to severely active Crohn’s Disease. 

Patients were randomized into treatment groups. One group received six milligrams/kilograms of Stelara intravenously at baseline, followed by 90 milligrams every eight weeks. The other group received 160/80 milligrams of adalimumab at baseline, followed by 40 milligrams every two weeks. Adalimumab is also known as Humira, a commonly used drug for Crohn’s disease and ulcerative colitis.

Overall, patients demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response, and endoscopic response through one year in patients with moderately to severely active Crohn’s. 

For example, 64.9 percent of Stelara-treated patients achieved clinical remission at one year versus 61 percent of adalimumab-treated patients. Clinical remission at one year was the study’s primary endpoint.

Additionally, 60.7 percent of Stelara-treated patients achieved corticosteroid-free remission, while 57.4 percent of adalimumab-treated patients saw the same results. The trial also found that 72.3 percent of patients treated with Stelara and 66.2 percent of patients treated with adalimumab achieved clinical response. 

Also, 56.5 percent of Stelara-treated patients and 55.4 percent of adalimumab-treated patients achieved patient-reported outcome symptom remission. 

However, more patients in the adalimumab treatment group (60.0 percent) achieved clinical remission at Week 16 compared to patients in the Stelara group (57.1 percent). Additionally, 30.7 percent of adalimumab-treated patients achieved endoscopic remission by Week 52 versus 28.5 percent of patients treated with Stelara.

“As the first head-to-head study of biologic therapies in Crohn’s disease, SEAVUE is filling an important knowledge gap in the gastrointestinal community,” Bruce E. Sands, MD, MS, chief of the Dr. Henry D. Janowitz division of gastroenterology and the Dr. Burrill B. Crohn professor of medicine at the Icahn Institute for Medicine at Mount Sinai Hospital, said in the announcement. 

“SEAVUE has generated data that confirm STELARA as an important option for people living with moderately to severely active Crohn’s disease who are new to biologic therapy,” Sands, who is also the SEAVUE study principal investigator, continued. 

Benefits of both treatments were seen across additional efficacy endpoints but did not demonstrate statistically significant differences.

For example, in patients with Simple Endoscopic Score for Crohn’s Disease, 41.9 percent of Stelara-treated patients and 36.9 percent of adalimumab-treated patients achieved endoscopic response at Week 52. 

The clinical response that was achieved at Week 16 was maintained at Week 52 in 88.6 percent of Stelara-treated patients and 78.0 percent of adalimumab-treated patients. 

Overall, safety results were consistent with prior experience for both treatments, a Johnson & Johnson spokesperson explained. 

Notably, discontinuation rates were lower for Stelara-treated patients (15.2 percent) versus adalimumab-treated patients (23.6 percent) when measured at Week 52 of the clinical trial. And among Stelara-treated patients and adalimumab-treated patients, 6.3 percent and 11.3 percent experienced adverse events that led to discontinuation of the drug, respectively.

“Until now, there have been no head-to-head trials comparing the safety and efficacy of prescription biologics to treat Crohn’s disease, a chronic condition that can cause persistent and debilitating symptoms which can have a profound impact on a person's daily life,” said Andrew Greenspan, MD, vice president of immunology medical affairs at Janssen.

“Armed with this new clinical trial data, doctors have a compelling option in STELARA for appropriate patients living with Crohn’s disease,” Greenspan continued. 

Additional outcomes for Stelara are being followed, including safety data from six Phase 2/3 studies of IBM in patients with Crohn’s Disease and ulcerative colitis, as well as long-term maintenance of improvement in health-related quality of life in patients with moderate to severe Crohn’s Disease.

Real-world effectiveness of Stelara in the treatment of Crohn’s Disease is also being assessed. So far, results showed that 40 percent of patients achieved clinical remission through 12 months.