Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease.
OBJECTIVE
Adalimumab has been shown to be efficacious and well-tolerated in Western patients with Crohn's disease. These 2 randomized, double-blind clinical trials evaluated adalimumab efficacy and safety in Japanese patients with moderate to severe Crohn's disease.


METHODS
90 patients enrolled in the induction trial and were randomized to receive adalimumab 160/80 mg, adalimumab 80/40 mg or placebo at Weeks 0/2. At Week 4, patients who achieved a decrease in CDAI ≥ 70 points versus Baseline entered the maintenance trial and were randomized to adalimumab 40 mg every other week or placebo for 52 weeks. All other patients received 4 more weeks of blinded adalimumab before entering the open-label portion of the maintenance trial. At/after Week 4 of the maintenance trial, blinded patients who flared/failed to respond entered the open-label portion. Open-label maintenance patients received adalimumab 40 mg every other week with the option of 80 mg every other week for flare/non-response.


RESULTS
Clinical remission rates at Week 4 in the induction trial were 33.3%, 17.6% and 13.0% in the adalimumab 160/80 mg, adalimumab 80/40 mg and placebo groups, respectively. Maintenance remission rates were 38.1% for adalimumab and 9.1% for placebo at Week 52. Anti-TNF naïve patients achieved greater efficacy than anti-TNF exposed patients. Patients randomized to adalimumab achieved greater quality of life improvement versus placebo. There were no clinically relevant differences in safety between adalimumab and placebo.


CONCLUSIONS
Adalimumab is effective and well-tolerated for inducing and maintaining clinical remission in Japanese patients with moderate to severe Crohn's disease.
Tokyo Medical & Dental University, Tokyo, Japan. mamoru.gast@tmd.ac.jp
Mamoru
M
Watanabe
Toshifumi
T
Hibi
Kathleen G
KG
Lomax
Susan K
SK
Paulson
Jingdong
J
Chao
M Shamsul
MS
Alam
Anne
A
Camez
D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D044466:Asian People; D002097:C-Reactive Protein / Q000378:metabolism; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D007564:Japan; D060046:Maintenance Chemotherapy; D008297:Male; D011788:Quality of Life; D012074:Remission Induction; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D000068879:Adalimumab