Introduction Infliximab (IFX) is a chimeric monoclonal antibody effective for inducing and maintaining remission in Crohn's disease. The safety and efficacy of retreatment with IFX after a short “drug holiday” was recently demonstrated in the STORI trial. However, data regarding re-treatment after a long drug holiday (>1 year) are few. With increased use of biologics, the number of patients who have lost response to both biologics is increasing. These patients have limited therapeutic options but retreatment with IFX has been proposed.
Methods We performed a retrospective review of patients with Crohn's disease who had been re-treated with IFX after a period off treatment of at least 1 year. Patients were identified from our biologics database and their records were reviewed. Patient details and clinical outcome measures were extracted into a standardised form.
Results 24 patients (14 male) were studied with a median age of 38 years (range: 21–61 years). 15 patients had responded to their first course of treatment; IFX was stopped due to episodic treatment being the norm at that time (n=9), patient choice (n=3), failure to re-attend for planned treatment (n=1) and development of strictures requiring surgery (n=2). The median time between stopping IFX and retreatment was 35 months (range 14–102). In this cohort, 80% responded to retreatment (12/15), 2 developed infusion reactions and 1 developed secondary loss of response. Median follow-up among continued responders was 20 months (range 2–43). Nine patients stopped their first course of IFX for either primary non-response (n=5), secondary loss of response (n=2) or infusion reaction (n=2). The median time between treatments was 32 months (range 18–42). In this cohort, 78% of patients responded to retreatment (7/9); 2 had infusion reactions. Follow-up among ongoing responders was for a median of 11 months (range: 2–84 months). All infusion reactions occurred on the second retreatment dose despite premedication with hydrocortisone (200 mg iv).
Conclusion Re-treatment with IFX after a drug holiday of at least 1 year was frequently successful, whether the patients had initially responded to IFX or not. The main limiting factor was the development of infusion reactions. We conclude that retreatment with IFX is a viable option in people with limited therapeutic options even if they failed to respond to their first course of treatment or have previously lost response.
Competing interests None declared.