More Evidence Supports Introducing Adalimumab Early in Patients With CD

In Crohn disease (CD), anti–tumor necrosis factor therapies like adalimumab have provided an alternative to long-term corticosteroid therapy and have reduced the need for many patients to have surgical interventions. It has been proposed that early treatment with biologics may lead to better outcomes and fewer complications—like strictures and fistulae—and findings from a recent study support that assertion.
The Center for Biosimilars Staff
December 03, 2019
In Crohn disease (CD), anti–tumor necrosis factor therapies like adalimumab have provided an alternative to long-term corticosteroid therapy and have reduced the need for many patients to have surgical interventions. It has been proposed that early treatment with biologics may lead to better outcomes and fewer complications—like strictures and fistulae—and findings from a recent study support that assertion.

The retrospective study was conducted among 157 patients with CD who were treated with adalimumab between 2008 and 2016 at a single center in Italy. The investigators analyzed whether early treatment with adalimumab (within 12 months of diagnosis with CD) improved patient outcomes.

The patients had a mean age of 43.99 years, and 68.15% were men. Most of the patients (91.01%) had received systemic corticosteroids before starting adalimumab, but not all responded to steroid treatment. Seventy-five of the patients had also used other therapies, including infliximab, azathioprine, and antibiotics.

At month 12 after initiating adalimumab, overall, 50.32% of patients achieved clinical remission. A clinical response was observed in 35.03% of patients. Among both those in remission and those with a response, 62.42% did not need steroids, and 37.58% showed mucosal healing.

Among the 80 patients who started adalimumab within 1 year of diagnosis, the clinical remission rate (66.25%) was significantly superior to the remission rate (33.77%) among the 77 patients who started adalimumab more than 1 year from diagnosis (P ≤.001).

Mucosal healing was observed in 53.75% of the early treatment group and in 20.78% of the late treatment group (P <.001), and dose escalation was required for 30.00% of the early treatment group and in 66.23% of the late treatment group (P <.01).

Finally, 7.50% of patients in the early treatment group were classified as nonresponders at the end of follow-up, versus 22.08% of patients in the late treatment group.  

Early treatment with adalimumab, write the study’s authors, may improve clinical outcomes by preventing fibrosis from developing by blocking the cascade of events leading to the fibrogenic process. “In light of our data, it is tempting to speculate that early control of gut inflammation is critical to prevent fibrostenotic intestinal injury previously described as a major factor leading to poor patient outcomes,” they write, adding that these data support introducing adalimumab during a “window period” before there are structural alterations to the bowel.

Reference
Mastronardi M, Curlo M, Cavalcanti E, et al. Administration timing is the best clinical outcome predictor for adalimumab administration in CD. Front Med (Lausanne). 2019;6:234. doi: 10.3389/fmed.2019.00234.

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