New analyses for STELARA® (ustekinumab) as first-line therapy for bio-naïve patients with moderately to severely active Crohn’s Disease and Ulcerative Colitis

Nov 4, 2021

Janssen announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA® was used as a first-line advanced therapy for bio-naïve patients with moderately to severely active UC relative to outcomes associated with second- or third-line use (P0540).1 Additionally, in a separate real-world claims analysis, a greater proportion of bio-naïve patients who started biologic therapy with STELARA (n=948) for moderately to severely active CD showed persistence at 12 months versus adalimumab (n=4,143) (P0525).2 These data are among 16 abstracts, including one oral presentation, presented at the 2021 American College of Gastroenterology Annual Scientific Meeting, which is taking place October 22-27 in Las Vegas, Nevada.1,2

“Data emerging from these analyses inform physicians with additional evidence to support STELARA as a first-line option for patients with moderately to severely active Crohn’s disease and ulcerative colitis,” said Christopher Gasink, M.D., Head of Immunology Medical Affairs, Gastroenterology, Janssen Scientific Affairs, LLC.

“Identifying the Optimal Treatment Sequence for STELARA in Treatment Algorithms for Advanced Therapies in UC (P0540)” results suggested: 
Initiating STELARA® as a first-line advanced therapy for UC in a hybrid decision tree model resulted in more favourable patient outcomes in terms of increased amount of time spent in remission or response and the postponing of surgery compared with second-line and third-line use.1

  • When used first-line, STELARA-treated patients in the cohort model spent on average:
    • 8.5 months (71 percent of the time) in remission or response over one year.1
    • 23.1 months (64 percent of the time) in remission or response over three years.1
    • 32.2 months (54 percent of the time) in remission or response over five years.1
  • When STELARA was used in the second-line setting, patients spent on average:
    • 7.9 months (66 percent of the time) in remission or response over one year.1
    • 14.5 months (40 percent of the time) in remission or response over three years.1
    • 17.5 months (29 percent of the time) in remission or response over five years.1
  • Modelled use of STELARA in the first- versus second-line reduced time affected by active UC by 0.6, 8.3, and 13.8 months over one, three, and five years, respectively. When compared to third-line, first-line use of STELARA suggested even greater reductions at the one-year (0.9 months), three-year (9 months), and five-year (14.5 months) timepoints.1
  • Future research is required to generate long-term clinical data to confirm these results.1

“Treatment Persistence Among Bio-Naïve Patients with CD Initiated on STELARA or adalimumab (P0525)” results suggested:
A higher proportion of bio-naive patients selected from the IQVIA PharMetrics® Plus claims database who started on STELARA (n=948) were persistent on therapy at 12 months, including persistent and corticosteroid-free and persistent and on monotherapy versus patients who started on adalimumab (n=4,143).2 Specifically, patients in the STELARA versus adalimumab cohort showed:

  • 50 percent higher rate of persistence on biologic (hazard ratio [HR] 1.50; 95% confidence interval [CI]: 1.29-1.74).2
  • 17 percent higher rate of persistence and being corticosteroid-free (HR: 1.17; 95% CI: 1.04-1.31).2
  • 47 percent higher rate of persistence on monotherapy (HR: 1.47; 95% CI: 1.30-1.65).2

“These analyses in ulcerative colitis and Crohn’s disease expand the body of data for STELARA and give us insight into treatment sequencing and persistence rates, which are important when assessing biologic therapy options for patients,” said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “Janssen is committed to conducting analyses that provide additional insight when treating patients with inflammatory bowel disease.”

Read the STELARA® results online.

Read more news from the Bowel Interest Group.

References

  1. Zhang S, et al. Identifying the Optimal Treatment Sequence for Ustekinumab in Treatment Algorithms for Advanced Therapies in Ulcerative Colitis (Abstract P0540). Presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, October 22-27, 2021.
  2. Pilon D, et al. Treatment persistence among bio-naïve patients with Crohn’s disease initiated on ustekinumab or adalimumab (Abstract P0525). Presented at the ACG Annual Scientific Meeting, October 22-27, 2021.
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