Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with
intolerance or loss of response to Infliximab. Currently there are no studies on the efficacy
of switching to Infliximab in patients with loss of response or primary non-response to
Adalimumab. Even in rheumatology, where switching between all classes of anti-TNFα
biologicals is common practice, there are no scientific data on switching from humanized to
chimeric anti-TNFα antibodies.
The purpose of this study is to document the efficacy of such a switch and to identify the
possible predictive factors for success.
If treatment with Adalimumab fails (despite optimal dose and interval) and the treating
physician therefore decided to switch to infliximab, the patient may be enrolled in this
observational study. At regular intervals (every Remicade), the patient will be clinically
re-evaluated. The disease activity score will be calculated: Crohn's disease activity index
(CDAI). At regular intervals, the results of interim blood tests will be documented (3x). The
succession will be 1 year. At week 10, 26 and 52, additional serum samples will be taken for
determination of antibodies against Adalimumab and Infliximab. The serum levels of Adalimumab
(week 0) and Infliximab (week 10, 26 and 52) will be determined.
For this study there is no specific therapy change. The study wants only to document the
results of a therapy switch that, in current clinical practice, is made by the treating
physician.