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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Aliment+Pharmacol+Ther
2013 ; 38
(10
): 1236-47
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Adalimumab maintains remission of Crohn s disease after up to 4 years of
treatment: data from CHARM and ADHERE
#MMPMID24134498
Panaccione R
; Colombel JF
; Sandborn WJ
; D'Haens G
; Zhou Q
; Pollack PF
; Thakkar RB
; Robinson AM
Aliment Pharmacol Ther
2013[Nov]; 38
(10
): 1236-47
PMID24134498
show ga
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).
|Adalimumab
[MESH]
|Anti-Inflammatory Agents/administration & dosage/adverse effects/*therapeutic use
[MESH]
|Antibodies, Monoclonal, Humanized/administration & dosage/adverse
effects/*therapeutic use
[MESH]