Janssen presents results of first head-to-head study of biologic therapies in patients with moderate to severe Crohn’s disease

The Janssen Pharmaceutical Companies of Johnson & Johnson announced efficacy and safety data for Stelara (ustekinumab) in Crohn’s disease (CD) and ulcerative colitis (UC),including data from the SEAVUE study, the first head-to-head study of biologic therapies in patients with CD, presented in a Clinical Science Late-Breaking Abstract Plenary session. SEAVUE data showed treatment with Stelara demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-naïve patients with moderately to severely active CD, although the primary endpoint of statistical superiority versus adalimumab was not demonstrated.

These head-to-head data are one of 20 abstracts Janssen presented from the Company’s gastroenterology pipeline and portfolio at DDW Virtual 2021, which took place May 21-23.

STELARA vs. adalimumab efficacy and safety in biologic-naïve CD patients through one year. (Presentation #775d): The SEAVUE study examined a total of 386 patients with moderately to severely active CD. Patients were randomized 1:1 to treatment with Stelara approximately 6 mg/kg intravenous (IV) at baseline, then 90 mg subcutaneous (SC) every eight weeks (q8w), or treatment with adalimumab 160/80 mg SC at baseline/week two, then 40 mg SC every two weeks per the FDA approved regimens without dose modifications. Results did not show statistically significant differences:Primary i. 64.9 percent of Stelara-treated patients and 61 percent of adalimumab-treated patients achieved clinical remission (Crohn’s Disease Activity Index [CDAI] <150) at one year (week 52), the study’s primary endpoint. Secondary :Major secondary endpoints were not significantly different between the groups: i.60.7 percent of Stelara-treated patients and 57.4 percent of adalimumab-treated patients achieved cortico-costeroid-free remission. ii. 72.3 percent of Stelara-treated patients and 66.2 percent of adalimumab-treated patients achieved clinical response. iii. 56.5 percent of Stelara-treated patients and 55.4 percent of adalimumab-treated patients achieved patient-reported outcome (PRO)-2 symptom remission. iv. At week 16, 57.1 percent of Stelara treated patients and 60 percent of adalimumab-treated patients achieved clinical remission. v. At week 52, in patients with Simple Endoscopic Score for Crohn’s Disease (SES-CD)b greater than 3 at baseline, 28.5 percent of Stelara-treated patients and 30.7 percent of adalimumab-treated patients achieved endoscopic remission.

Benefits for both treatments were also demonstrated across additional efficacy endpoints, but did not demonstrate statistically significant differences : i.At week 52, in patients with SES-CD ?3 at baseline, 41.9 percent of Stelara-treated patients and 36.9 percent of adalimumab-treated patients achieved endoscopic response. ii. Clinical response achieved at week 16 was maintained at week 52 in 88.6 percent of Stelara-treated patients and 78 percent of adalimumab-treated patients. iii. The mean change from baseline to week 52 in the number of liquid/soft stools in the prior seven days was -19.9 for Stelara-treated patients and -16.2 for adalimumab-treated patients. The mean change from baseline to week 52 in the sum of number of liquid/soft stools and abdominal pain scores in the prior seven days was -29.6 for Stelara-treated patients and -25.1 for adalimumab-treated patients.

Safety results were consistent with prior experience for both treatments. Discontinuation rates were numerically lower for Stelara-treated patients (15.2 percent) versus adalimumab-treated patients (23.6 percent) who discontinued before week 52. Among Stelara-treated patients and adalimumab-treated patients, 6.3 percent and 11.3 percent had adverse events (AEs) that led to discontinuation of study 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, M.D., Vice President, Immunology Medical Affairs, Janssen Scientific Affairs, LLC. “Armed with this new clinical trial data, doctors have a compelling option in Stelara for appropriate patients living with Crohn’s disease.”