Therapies that maintain remission for patients with Crohn's disease are essential. Stable remission rates have been demonstrated for up to 2 years in adalimumab-treated patients with moderately to severely active Crohn's disease enrolled in the CHARM and ADHERE clinical trials.
Dr Panaccione and colleagues from Canada presented the long-term efficacy and safety of adalimumab therapy through 4 years of treatment.
Remission, response and corticosteroid-free remission over 4 years, and maintenance of these endpoints beyond 1 year were assessed in CHARM early responders randomized to adalimumab.
Corticosteroid-free remission was also assessed in all adalimumab-randomized patients using corticosteroids at baseline. Fistula healing was assessed in adalimumab-randomised patients with fistula at baseline.
As observed, last observation carried forward and a hybrid nonresponder imputation analysis for year 4 (hNRI) were used to report efficacy.
|54% with remission at year 1 maintained this endpoint at year 4 |
|Alimentary Pharmacology & Therapeutics|
The team reported adverse events for any patient receiving at least one dose of adalimumab.
Of 329 early responders randomized to adalimumab induction therapy, at least 30% achieved remission or CR-100 at year 4 of treatment (hNRI).
The team found that 54% of patients with remission at year 1 maintained this endpoint at year 4 (hNRI).
At year 4, 16% of patients taking corticosteroids at baseline were in corticosteroid-free remission, and 24% of patients with fistulae at baseline had healed fistulae.
The researchers observed that the incidence rates of adverse events remained stable over time.
Dr Panaccione's team concludes, "Prolonged adalimumab therapy maintained clinical remission and response in patients with moderately to severely active Crohn's disease for up to 4 years."
"No increased risk of adverse events or new safety signals were identified with long-term maintenance therapy."