In this study, an international team of doctors compared episodic and scheduled infliximab treatment strategies for Crohn's disease.
Initially 573 patients received 5 mg/kg infliximab at week 0.
Patients were then randomized to either:
- placebo infusions at weeks 2 and 6 and every 8 weeks until week 46 (episodic)
- infliximab 5 mg/kg at weeks 2 and 6 then every 8 weeks (5 mg/kg scheduled)
- or infliximab 5 mg/kg at weeks 2 and 6 then 10 mg/kg every 8 weeks (10 mg/kg scheduled).
In addition, patients could be given a dose of infliximab 5 mg/kg at week 14 upon loss of response.
|Fewer patients in the scheduled groups developed antibodies to infliximab.|
The doctors determined that the efficacy of scheduled infliximab therapy was better than episodic treatment.
Furthermore, the Crohn’s Disease Activity Index (CDAI) scores were consistently better in the 10 mg/kg group from weeks 10 to 54.
The team also found that response and remission rates in the scheduled groups were significantly higher from weeks 10 to 30. More patients achieved complete mucosal healing at week 54.
The team determined that fewer patients in the scheduled groups developed antibodies to infliximab. They also had fewer Crohn’s disease-related hospitalizations and surgeries than episodic strategy patients.
Dr Paul Rutgeerts's team concluded, "The scheduled infliximab groups, particularly the 10 mg/kg group, had better CDAI and Inflammatory Bowel Disease Questionnaire (IBDQ) responses than those in the episodic group".
"Both scheduled groups had fewer hospitalizations, higher rates of mucosal healing, and fewer developed antibodies than those in the episodic group, with no increase in side effects".