Early initiation of Humira improves remission rates in Crohn’s disease

SAN DIEGO — Earlier introduction of adalimumab – within 2 years of diagnosis – substantially improves remission rates among patients with Crohn’s disease who have poor prognostic factors at the time of diagnosis, according to a study presented at Digestive Disease Week.

“Real-world data on the effectiveness of anti-tumor necrosis factor [agents] on [patients with Crohn’s disease] bearing poor prognosis factors are scarce,” Gerassimos Mantzaris, MD, PhD, from the General Hospital of Athens in Greece, and colleagues wrote.

Mantzaris and colleagues conducted a multicenter, retrospective, chart-review study to determine, with real-world evidence, how early initiation of Humira (adalimumab, AbbVie) affects the 26-week clinical remission rate in patients with Crohn’s disease compared with delayed initiation of the drug. Clinical remission was defined as a Harvey-Bradshaw Index (HBI) of 4 or less.

The researchers enrolled 171 eligible patients with moderately to severely active Crohn’s disease (HBI  8) who were naive to treatment with biologic therapy or exposed to biologic therapy at the start of therapy with adalimumab and had at least three poor prognosis factors at diagnosis, such as ileal or ileocolonic location, age 40 years or younger, active smoking, extensive and deep ulceration, severe rectal and/or perianal disease and upper gastrointestinal involvement. They excluded patients with Crohn’s disease-related intestinal resection before starting adalimumab.

Participants initiated adalimumab between July 1, 2007 and February 8, 2017.

Participants who had Crohn’s disease for less than 24 months before beginning adalimumab were grouped into the early cohort (n = 62; 36.3%) and those with a disease duration of more than 24 months before starting adalimumab were grouped into the delayed cohort (n = 109; 63.7%). At diagnosis, there was a median of three poor prognosis factors (range, 3 to 4) in each cohort.

Using the last observation carried forward imputation method, the researchers found that the 26-week HBI remission rates off steroids was 60.7% in the early cohort and 47.2% in the delayed cohorts (delta = 13.5%; one-sided P = .044).

Among anti-TNF naive participants, the remission rate was 61.2% in the early cohort and 42.4% in the delayed cohort (one-sided P = .023). The remission rate among anti-TNF experienced patients was 58.3% in the early cohort and 53.2% in the delayed cohort (one-sided P = .374).

“In patients with Crohn’s disease and poor prognosis factors, early initiation of adalimumab, within 2 years of diagnosis, achieves significantly higher remission rates compared with delayed introduction of adalimumab,” Mantzaris and colleagues wrote. “This effect is more prominent in biologic-naïve patients.” – by Alaina Tedesco

 

Reference:

Mantzaris GJ, et al. Abstract Mo1905. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.

Disclosure: Mantzaris reports receiving consulting fees from AbbVie for advisory committees or review panels, consulting and speaking and teaching; consulting fees from Celgene for advisory committees or review panels and speaking and teaching; consulting fees from Danone for speaking and teaching; consulting fees from Ferring for advisory committees or review panels and speaking and teaching; consulting fees from Genesis for advisory committees or review panels, consulting and grant/research support; consulting fees from Galenica for grant/research support and speaking and teaching; and consulting fees from Hospira for consulting.

SAN DIEGO — Earlier introduction of adalimumab – within 2 years of diagnosis – substantially improves remission rates among patients with Crohn’s disease who have poor prognostic factors at the time of diagnosis, according to a study presented at Digestive Disease Week.

“Real-world data on the effectiveness of anti-tumor necrosis factor [agents] on [patients with Crohn’s disease] bearing poor prognosis factors are scarce,” Gerassimos Mantzaris, MD, PhD, from the General Hospital of Athens in Greece, and colleagues wrote.

Mantzaris and colleagues conducted a multicenter, retrospective, chart-review study to determine, with real-world evidence, how early initiation of Humira (adalimumab, AbbVie) affects the 26-week clinical remission rate in patients with Crohn’s disease compared with delayed initiation of the drug. Clinical remission was defined as a Harvey-Bradshaw Index (HBI) of 4 or less.

The researchers enrolled 171 eligible patients with moderately to severely active Crohn’s disease (HBI  8) who were naive to treatment with biologic therapy or exposed to biologic therapy at the start of therapy with adalimumab and had at least three poor prognosis factors at diagnosis, such as ileal or ileocolonic location, age 40 years or younger, active smoking, extensive and deep ulceration, severe rectal and/or perianal disease and upper gastrointestinal involvement. They excluded patients with Crohn’s disease-related intestinal resection before starting adalimumab.

Participants initiated adalimumab between July 1, 2007 and February 8, 2017.

Participants who had Crohn’s disease for less than 24 months before beginning adalimumab were grouped into the early cohort (n = 62; 36.3%) and those with a disease duration of more than 24 months before starting adalimumab were grouped into the delayed cohort (n = 109; 63.7%). At diagnosis, there was a median of three poor prognosis factors (range, 3 to 4) in each cohort.

Using the last observation carried forward imputation method, the researchers found that the 26-week HBI remission rates off steroids was 60.7% in the early cohort and 47.2% in the delayed cohorts (delta = 13.5%; one-sided P = .044).

Among anti-TNF naive participants, the remission rate was 61.2% in the early cohort and 42.4% in the delayed cohort (one-sided P = .023). The remission rate among anti-TNF experienced patients was 58.3% in the early cohort and 53.2% in the delayed cohort (one-sided P = .374).

“In patients with Crohn’s disease and poor prognosis factors, early initiation of adalimumab, within 2 years of diagnosis, achieves significantly higher remission rates compared with delayed introduction of adalimumab,” Mantzaris and colleagues wrote. “This effect is more prominent in biologic-naïve patients.” – by Alaina Tedesco

 

Reference:

Mantzaris GJ, et al. Abstract Mo1905. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.

Disclosure: Mantzaris reports receiving consulting fees from AbbVie for advisory committees or review panels, consulting and speaking and teaching; consulting fees from Celgene for advisory committees or review panels and speaking and teaching; consulting fees from Danone for speaking and teaching; consulting fees from Ferring for advisory committees or review panels and speaking and teaching; consulting fees from Genesis for advisory committees or review panels, consulting and grant/research support; consulting fees from Galenica for grant/research support and speaking and teaching; and consulting fees from Hospira for consulting.

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