Adalimumab maintains remission of Crohn's disease after up to 4 years of
treatment: data from CHARM and ADHERE.
Author(s): Panaccione R(1), Colombel JF, Sandborn WJ, D'Haens G, Zhou Q, Pollack PF, Thakkar
RB, Robinson AM.
Affiliation(s): Author information:
(1)Inflammatory Bowel Disease Clinic, Division of Gastroenterology, Department of
Medicine, University of Calgary, Calgary, AB, Canada.
Publication date & source: 2013, Aliment Pharmacol Ther. , 38(10):1236-47
BACKGROUND: 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.
AIM: To present the long-term efficacy and safety of adalimumab therapy through 4
years of treatment.
METHODS: Remission (CDAI <150), response (CR-100) and corticosteroid-free
remission over 4 years, and maintenance of these endpoints beyond 1 year were
assessed in CHARM early responders randomised to adalimumab. Corticosteroid-free
remission was also assessed in all adalimumab-randomised 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. Adverse events were reported for any
patient receiving at least one dose of adalimumab.
RESULTS: Of 329 early responders randomised to adalimumab induction therapy, at
least 30% achieved remission (99/329) or CR-100 (116/329) at year 4 of treatment
(hNRI). The majority of patients (54%) 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 incidence rates of adverse events remained
stable over time.
CONCLUSIONS: 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. (clinicaltrials.gov number:
NCT00077779).
|