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

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.”></150)>