Immunogenicity to biologic drugs in IBD (IMGEN) is a new study added to Predicting Drug Side Effects in Gastroenterology (PRED4) at the beginning of 2018:
The inclusion criteria are as follows:
- Patient currently aged ≥ 6 years
- History of ulcerative colitis (UC) or Crohn’s disease (CD)
- Biologic drug and antibody concentrations previously measured in Exeter, or patient prepared prepared to give sample for this purpose.
- At time of drug and antibody measurement:
- Biologic treatment duration >24 months, or
- Treatment duration ≤ 24 months with episode of loss of response requiring escalation of immunomodulatory, steroid or biologic therapy, or withdrawal of current biologic therapy.
- Drug and antibody level taken at one of the following time points:
- For patients still on drug: within 72 hours prior to the next dose of drug (trough level), or
- For patients who have stopped drug: no sooner than 72 hours before and no later than one month after their next dose would have been due and before starting next biologic
- Patient has not participated in PANTS study.
- Patient is able to provide informed consent.
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