Efficacy data for ustekinumab in Crohn’s disease & ulcerative colitis released

May 24, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson have released 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 ustekinumab 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.

“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,” said Bruce E. Sands, M.D., M.S., Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology), at the Icahn Institute for Medicine at Mount Sinai, and SEAVUE study principal investigator.

Ustekinumab 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 randomised 1:1 to treatment with ustekinumab 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 US Food and Drug Administration-approved regimens without dose modifications. Results did not show statistically significant differences:

  • 64.9 percent of ustekinumab-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.
  • Major secondary endpoints were not significantly different between the groups:
    • o 60.7 percent of ustekinumab-treated patients and 57.4 percent of adalimumab-treated patients achieved corticosteroid-free remission.
    • o 72.3 percent of ustekinumab-treated patients and 66.2 percent of adalimumab-treated patients achieved clinical response.
    • o 56.5 percent of ustekinumab-treated patients and 55.4 percent of adalimumab-treated patients achieved patient-reported outcome (PRO)-2 symptom remission.
    • o At week 16, 57.1 percent of ustekinumab-treated patients and 60 percent of adalimumab-treated patients achieved clinical remission.
    • o At week 52, in patients with Simple Endoscopic Score for Crohn’s Disease (SES-CD)c ≥3 at baseline, 28.5 percent of ustekinumab-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:
    • At week 52, in patients with SES-CD ≥3 at baseline, 41.9 percent of ustekinumab-treated patients and 36.9 percent of adalimumab-treated patients achieved endoscopic response.
    • Clinical response achieved at week 16 was maintained at week 52 in 88.6 percent of ustekinumab-treated patients and 78 percent of adalimumab-treated patients.
    • The mean change from baseline to week 52 in the number of liquid/soft stools in the prior seven days was -19.9 for ustekinumab-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 ustekinumab-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 ustekinumab-treated patients (15.2 percent) versus adalimumab-treated patients (23.6 percent) who discontinued before week 52.
    • Among ustekinumab-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.
    • Adverse events were reported in 80.1 percent and 77.9 percent of patients receiving ustekinumab or adalimumab, respectively.
    • Serious adverse events (SAEs) were reported in 13.1 percent and 16.4 percent of patients, including serious infections reported in 2.1 percent and 2.6 percent of patients receiving ustekinumab or adalimumab, respectively.
    • Through week 52, one patient developed basal cell carcinoma of the skin after receiving adalimumab; no patient reported malignancies after receiving ustekinumab. No deaths were reported through week 52.“

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 ustekinumab for appropriate patients living with Crohn’s disease.”

Read more news on bowel health from the Bowel Interest Group