Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial.
OBJECTIVE
This study evaluated the efficacy and safety of adalimumab, a fully human, anti-tumor necrosis factor monoclonal antibody administered subcutaneously, in the maintenance of response and remission in patients with moderate to severe Crohn's disease (CD).


METHODS
Patients received open-label induction therapy with adalimumab 80 mg (week 0) followed by 40 mg (week 2). At week 4, patients were stratified by response (decrease in Crohn's Disease Activity Index > or =70 points from baseline) and randomized to double-blind treatment with placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg weekly through week 56. Co-primary end points were the percentages of randomized responders who achieved clinical remission (Crohn's Disease Activity Index score <150) at weeks 26 and 56.


RESULTS
The percentage of randomized responders in remission was significantly greater in the adalimumab 40-mg eow and 40-mg weekly groups versus placebo at week 26 (40%, 47%, and 17%, respectively; P < .001) and week 56 (36%, 41%, and 12%, respectively; P < .001). No significant differences in efficacy between adalimumab eow and weekly were observed. More patients receiving placebo discontinued treatment because of an adverse event (13.4%) than those receiving adalimumab (6.9% and 4.7% in the 40-mg eow and 40-mg weekly groups, respectively).


CONCLUSIONS
Among patients who responded to adalimumab, both adalimumab eow and weekly were significantly more effective than placebo in maintaining remission in moderate to severe CD through 56 weeks. Adalimumab was well-tolerated, with a safety profile consistent with previous experience with the drug.
Colombel
Jean-Frédéric
JF
Department of Hepatogastroenterology, Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille, Rue Michel Polonovski, 59037 Lille, France. jfcolombel@chru-lille.fr
Sandborn
William J
WJ
Rutgeerts
Paul
P
Enns
Robert
R
Hanauer
Stephen B
SB
Panaccione
Remo
R
Schreiber
Stefan
S
Byczkowski
Dan
D
Li
Ju
J
Kent
Jeffrey D
JD
Pollack
Paul F
PF
D000068879:Adalimumab; D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy* / Q000276:immunology*; D016154:Digestive System Fistula / Q000188:drug therapy / Q000209:etiology / Q000276:immunology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D010919:Placebos; D000068879:Adalimumab