Efficacy and complications of adalimumab treatment for medically‐refractory Crohn’s disease: analysis of nationwide experience in Scotland (2004–2008)

• Published in: Alimentary pharmacology & therapeutics 2009-03, Vol.29 (5), p.527-534
• Main Authors: HO, G. T., MOWAT, A., POTTS, L., CAHILL, A., MOWAT, C., LEES, C. W., HARE, N. C., WILSON, J. A., BOULTON‐JONES, R., PRIEST, M., WATTS, D. A., SHAND, A. G., ARNOTT, I. D., RUSSELL, R. K., WILSON, D. C., MORRIS, A. J., SATSANGI, J.
• Format: Article
• Language: English
• Subjects: Adalimumab; Adolescent; Adult; Anti-Inflammatory Agents - adverse effects; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal, Humanized; Biological and medical sciences; Crohn Disease - drug therapy; Crohn Disease - mortality; Digestive system; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Male; Medical sciences; Other diseases. Semiology; Pharmacology. Drug treatments; Scotland; Statistics as Topic; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Time Factors; Treatment Outcome; Tumor Necrosis Factor-alpha - adverse effects; Tumor Necrosis Factor-alpha - antagonists & inhibitors; Young Adult
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2008.03919.x

Summary Background  Adalimumab is a second generation humanized anti‐tumour necrosis factor (TNF) monoclonal antibody with established efficacy in Crohn’s disease (CD). Aims  To evaluate the efficacy and safety of adalimumab on a nationwide clinical setting. Methods  We used the Scottish Society of Gastroenterology network to identify and follow up the clinical outcomes of patients with CD treated with adalimumab over a 4‐year period (2004–2008). Results  A total of 98 patients received adalimumab ‐ 100.5 patient follow‐up years were recorded (64.3% females; median age at diagnosis of 20.7 years; 88.8% treated with 80/40 mg induction regimen. Eighty eight (89.8%) had previous infliximab with 29 (32.9%) primary nonresponders; 32 (32.6%) were corticosteroid‐dependent; 47 (47.9%) were intolerant/resistant to most immunosuppressive therapies (two or more). In all, 60% of patients were in clinical remission at 1‐year follow‐up, with 30% and 55% requiring dose escalation to weekly therapy at 1‐and 2‐year follow‐up respectively. Overall, 29 (29.6%) patients developed complications with eight nonfatal serious (8.2%) adverse events and 2 (2.0%) case fatalities (sepsis following perforation and disseminated colorectal cancer, respectively). Conclusions  Adalimumab is efficacious in severe and refractory CD in the clinical setting, although there remain significant therapy‐ and disease‐related risks of serious complications.