Efficacy of adalimumab for the management of inflammatory bowel disease in the clinical setting.
BACKGROUND
Anti-tumor necrosis factor (TNF)-alpha medications are effective in Crohn's Disease (CD) and efficacious in ulcerative colitis (UC). Adalimumab has been available through the Australian Pharmaceutical Benefits Scheme since August 2008, but clinical experience for inflammatory bowel disease (IBD) in Australia is limited.


OBJECTIVE
To determine adalimumab efficacy for IBD in the Australian setting.


METHODS
Crohn's disease or UC/IBD unclassified (UC/IBDU) patients received adalimumab after failure of disease control with conventional therapies or loss of control by infliximab. Response/remission at 8 and 12 weeks were determined by the Crohn's Disease Activity Index (CDAI) and Colitis Activity Index (CAI). All patients received 160 mg (week 0), 80 mg (week 2), followed by 40 mg every-other-week (eow). Patients with a limited response at 8 weeks were considered for weekly adalimumab.


RESULTS
Of 38 CD patients 86.8% (33/38) had active luminal and 23.7% (9/38) fistulising disease at inclusion. Response occurred in 81.8% and 84.4% of luminal CD at 8 and 12 weeks, while 54.5% and 63.6% remitted respectively. 77.8% of fistulising CD responded and 55.6% remitted at 12 weeks. Fifteen CD patients had previously lost response to infliximab, and 86.7% of these responded and 53.3% remitted at 12 weeks. Of the seven UC/IBDU patients 43% and 14% responded, while 29% and 0% remitted at 8 and 12 weeks.


CONCLUSIONS
In CD, adalimumab is as, if not more, effective in the clinical setting than in the trials, and is effective in patients with an attenuated response to infliximab. Its efficacy is not as good in UC, but this requires further clarification.
Trinder
Matthew W
MW
Centre for inflammatory Bowel Diseases, University of Western Australia, Fremantle Hospital, Western Australia, Australia.
Lawrance
Ian C
IC
D000068879:Adalimumab; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001315:Australia; D002648:Child; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D017211:Treatment Failure; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab