Johnson and Johnson Announce Analyses of Stelara for Crohn’s Disease and Ulcerative Colitis

Johnson and Johnson (J&J) announced data from 2 new analyses of ustekinumab (Stelara) for the treatment of adults with moderately to severely active Crohn disease (CD) and ulcerative colitis (UC), according to a statement from the company.

“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,” Christopher Gasink, MD, head of immunology medical affairs of gastroenterology at J&J subsidiary Janssen Scientific Affairs, LLC, said in the statement.

“Many patients living with inflammatory bowel disease can cycle through different therapies as a result of loss or lack of treatment response. Studies like these are important in helping guide physicians to select an appropriate therapeutic option for their patients in a first-line setting.” Gasink said.

Study results show that time spent in clinical remission or response was higher for individuals when ustekinumab was used as a first-line treatment for moderately to severely active UC compared to second- or third-line use.

Individuals treated with ustekinumab as a first-line treatment spent 8.5 months, or 71% of the time, in remission or response for more than 1 year; 23.1 months, or 64% of the time, in remission or response over 3 years; and 32.2 months, or 54% of the time, in remission or response over 5 years.

When treated with ustekinumab as a second-line treatment, individuals spent 7.9 months, or 66% of the time, in remission or response over 1 year; 14.5 months, or 40% of the time, in remission or response over 3 years; and 17.5 months, or 29% of the time, in remission or response over 5 years.

Additionally, in a separate analysis, a greater proportion of individuals who started biological therapy with ustekinumab for moderately to severely active CD showed persistence at 12 months compared with those treated with adalimumab.

There was a 50% higher rate of persistence for individuals on biologics, 17% higher rate of persistence and being corticosteroid-free, and 47% higher rate ofpersistence on monotherapy.

The results were presented at the 2021 American College of Gastroenterology Annual Scientific Meeting.

Reference

New analyses suggest favorable results for STELARA® (ustekinumab) when used as a first-Line therapy for bio-naïve patients with moderately to severely active Crohn’s disease and ulcerative colitis. Johnson & Johnson. News release. October 25, 2021. Accessed October 26, 2021. https://www.jnj.com/new-analyses-suggest-favorable-results-for-stelara-ustekinumab-when-used-as-a-first-line-therapy-for-bio-naive-patients-with-moderately-to-severely-active-crohns-disease-and-ulcerative-colitis

“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,” Christopher Gasink, MD, head of immunology medical affairs of gastroenterology at J&J subsidiary Janssen Scientific Affairs, LLC, said in the statement.

“Many patients living with inflammatory bowel disease can cycle through different therapies as a result of loss or lack of treatment response. Studies like these are important in helping guide physicians to select an appropriate therapeutic option for their patients in a first-line setting.” Gasink said.

Study results show that time spent in clinical remission or response was higher for individuals when ustekinumab was used as a first-line treatment for moderately to severely active UC compared to second- or third-line use.

Individuals treated with ustekinumab as a first-line treatment spent 8.5 months, or 71% of the time, in remission or response for more than 1 year; 23.1 months, or 64% of the time, in remission or response over 3 years; and 32.2 months, or 54% of the time, in remission or response over 5 years.

When treated with ustekinumab as a second-line treatment, individuals spent 7.9 months, or 66% of the time, in remission or response over 1 year; 14.5 months, or 40% of the time, in remission or response over 3 years; and 17.5 months, or 29% of the time, in remission or response over 5 years.

Additionally, in a separate analysis, a greater proportion of individuals who started biological therapy with ustekinumab for moderately to severely active CD showed persistence at 12 months compared with those treated with adalimumab.

There was a 50% higher rate of persistence for individuals on biologics, 17% higher rate of persistence and being corticosteroid-free, and 47% higher rate ofpersistence on monotherapy.

The results were presented at the 2021 American College of Gastroenterology Annual Scientific Meeting.

Reference

New analyses suggest favorable results for STELARA® (ustekinumab) when used as a first-Line therapy for bio-naïve patients with moderately to severely active Crohn’s disease and ulcerative colitis. Johnson & Johnson. News release. October 25, 2021. Accessed October 26, 2021. https://www.jnj.com/new-analyses-suggest-favorable-results-for-stelara-ustekinumab-when-used-as-a-first-line-therapy-for-bio-naive-patients-with-moderately-to-severely-active-crohns-disease-and-ulcerative-colitis