Long-term efficacy of adalimumab in paediatric Crohn's disease patients naïve to other anti-TNF therapies.
BACKGROUND
Adalimumab is a fully-humanized anti-TNF a antibody that has showed its efficacy in Crohn's disease (CD) adult patients. Its less immunogenic composition seems to be an advantage compared to previous anti-TNF α, mainly infliximab. Good response to adalimumab has been reported in patients naïve to infliximab, in those in whom infliximab has shown no efficacy and in those intolerant or who have lost previous response to it. Adalimumab has shown also its efficacy as a second-line anti-TNF α in small series of paediatric CD but data regarding its use in children naïve to infliximab are scarce.


OBJECTIVE
To report our experience with adalimumab as first line anti-TNF α treatment in paediatric CD.


METHODS
Four CD paediatric patients (2 boys) previously naïve to infliximab have received adalimumab. Mean age at diagnosis: 13 years, 4 months. Adalimumab was initiated in our patients soon after diagnosis (mean time from diagnosis: 8.5 months, range: 1 month 15 days-14 months) at decreasing loading doses (160 mg and 80 mg two weeks after) and then 40 mg subsequently every two weeks.


RESULTS
The four patients entered in remission after the first dose of adalimumab (mean previous PCDAI: 35, mean PCDAI after first dose: 3.6). No adverse effects were registered. Azathioprine was stopped after 4 months of combination therapy, without loss of efficacy or adverse reactions attributable to immunogenicity. All the 4 patients have remained in remission on adalimumab monotherapy for a mean follow-up of 17 months (range 9-20 months).


CONCLUSIONS
Adalimumab has shown its efficacy in our paediatric CD patients naïve to other anti-TNF α drugs. Early introduction of anti-TNF α antibodies in these patients could help to a better control of the disease. Its less immunogenicity and the possibility of a home-based administration are advantages when compared to other parenteral anti-TNF treatments. Change to monotherapy after prior successful combination therapy with azathioprine and adalimumab is a safe strategy that can help to minimize possible risks of intensive immunomodulation.
Pediatric Inflammatory Bowel Disease Unit, Department of Paediatric Gastroenterology, Hepatology and Nutrition, Hospital Sant Joan de Déu, Barcelona, Spain. javermartin@hsjdbcn.org
J
J
Martín-de-Carpi
N
N
Pociello
V
V
Varea
D000068879:Adalimumab; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002648:Child; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D015122:Mercaptopurine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; C488629:azathiopurine; D015122:Mercaptopurine; D000068879:Adalimumab