Most patients who have active Crohn's disease are treated initially with corticosteroids.
Although this approach usually controls symptoms, many patients become resistant to or dependent on corticosteroids, and long exposure is associated with an increased risk of mortality.
|31% in the early combined immunosuppression group had serious adverse events|
Dr Geert D'Haens and colleagues from Belgium compared the effectiveness of early use of combined immunosuppression with conventional management in patients with active Crohn's disease.
Patients had not previously received glucocorticoids, antimetabolites, or infliximab.
The team of doctors undertook a 2-year open-label randomized trial at 18 centres in Belgium, Holland, and Germany between 2001 and 2004.
The team randomly assigned 133 patients to either early combined immunosuppression or conventional treatment.
The 67 patients assigned to combined immunosuppression received 3 infusions of infliximab at weeks 0, 2, and 6, with azathioprine.
The team gave additional treatment with infliximab and, if necessary, corticosteroids, to control disease activity.
The doctors assigned 66 patients to conventional management, who received corticosteroids, followed, in sequence, by azathioprine and infliximab.
The primary outcome measures were remission without corticosteroids, and without bowel resection at weeks 26 and 52.
Analysis was by modified intention to treat.
The doctors reported that 4 patients did not receive treatment as per protocol.
At week 26, 60% of patients in the combined immunosuppression group were in remission without corticosteroids, and without surgical resection.
The team noted that at week 26, 36% of controls were in remission.
The absolute difference between the 2 groups was 24%.
The team found corresponding rates at week 52 were 62% and 42%.
The team of doctors observed that 31% of patients in the early combined immunosuppression group had serious adverse events, compared with 25% controls.
Dr D'Haens' team concluded, "Combined immunosuppression was more effective than conventional management for induction of remission and reduction of corticosteroid use in patients who had been recently diagnosed with Crohn's disease."
"Initiation of more intensive treatment early in the course of the disease could result in better outcomes."