Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial.
BACKGROUND
Adalimumab induced clinical remission after four weeks in patients with active Crohn's disease in the CLASSIC I trial.


OBJECTIVE
To evaluate long term efficacy and safety of adalimumab maintenance therapy in Crohn's disease in a follow-on randomised controlled trial (CLASSIC II).


METHODS
In the preceding CLASSIC I trial, 299 patients with moderate to severe Crohn's disease naive to tumour necrosis factor antagonists received induction therapy with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg, or placebo, at weeks 0 and 2. In all, 276 patients from CLASSIC I enrolled in CLASSIC II and received open-label adalimumab 40 mg at weeks 0 (week 4 of CLASSIC I) and 2; 55 patients in remission at both weeks 0 and 4 were re-randomised to adalimumab 40 mg every other week, 40 mg weekly, or placebo for 56 weeks. Patients not in remission at both weeks 0 and 4 were enrolled in an open-label arm and received adalimumab 40 mg every other week. With non-response or flare, these patients could have their dosages increased to 40 mg weekly. Patients in the randomised arm with continued non-response or disease flare could switch to open-label adalimumab 40 mg every other week and again to 40 mg weekly. The primary end point was maintenance of remission (CDAI <150) in randomised patients through week 56.


RESULTS
Of 55 patients randomised at week 4, 79% who received adalimumab 40 mg every other week and 83% who received 40 mg weekly were in remission at week 56, v 44% for placebo (p<0.05). In all, 204 patients entered the open-label arm. Of these, 93 (46%) were in clinical remission at week 56. Adalimumab was generally well-tolerated in all patients.


CONCLUSIONS
Adalimumab induced and maintained clinical remission for up to 56 weeks in patients with moderate to severe Crohn's disease naive to anti-TNF treatment.
Sandborn
W J
WJ
Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. sandborn.william@mayo.edu
Hanauer
S B
SB
Rutgeerts
P
P
Fedorak
R N
RN
Lukas
M
M
MacIntosh
D G
DG
Panaccione
R
R
Wolf
D
D
Kent
J D
JD
Bittle
B
B
Li
J
J
Pollack
P F
PF
D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D000906:Antibodies / Q000097:blood; D000974:Antibodies, Antinuclear / Q000097:blood; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D061067:Antibodies, Monoclonal, Humanized; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D008134:Long-Term Care / Q000379:methods; D008297:Male; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000906:Antibodies; D000974:Antibodies, Antinuclear; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000068879:Adalimumab