An international team assessed the benefit of maintenance infliximab therapy in patients with active Crohn's disease who respond to a single infusion of infliximab.
A total of 573 patients, with a score of at least 220 on the Crohn's disease activity index (CDAI), were included in the study.
Each received a 5 mg/kg intravenous infusion of infliximab at baseline.
After assessment of response at week 2, patients were randomly assigned to 1 of three regimens.
In Group I (n = 110), repeat infusions of placebo at weeks 2 and 6, and then every 8 weeks thereafter until week 46, were given.
Group II (n = 113) received repeat infusions of 5 mg/kg infliximab at the same timepoints.
Group III (n = 112) was given 5 mg/kg infliximab at weeks 2 and 6, followed by 10 mg/kg.
The proportion of patients who responded at week 2 and were in remission (CDAI < 150) at week 30 was measured.
Furthermore, the time to loss of response up to week 54, in patients who responded, was assessed.
|Patient remission at week 30:|
Group I: 21%
Group II: 39%
Group III: 45%
It was found that 58% of the patients responded to a single infusion of infliximab within 2 weeks.
At week 30, 21% of Group I patients were in remission, compared with 39% Group II and 45% of Group III patients.
Thus, patients in Groups II and III combined were more likely to sustain clinical remission than patients in Group I (odds ratio, 2·7).
Throughout the 54-week trial, the median time to loss of response was 38 weeks and more than 54 weeks for Groups II and III, respectively. These compared with 19 weeks for Group I.
The authors found that infliximab safety was consistent with that seen in other trials of infliximab in Crohn's disease and rheumatoid arthritis.
In particular, the incidence of serious infections was similar across treatment groups.
Dr Stephen B. Hanauer, of the University of Chicago Medical Center, Chicago, Illinois, USA, concluded on behalf of his group, "Patients with Crohn's disease who respond to an initial dose of infliximab are more likely to be in remission at weeks 30 and 54, if infliximab treatment is maintained every 8 weeks.
"They are also more likely to discontinue corticosteroids, and to maintain their response for a longer period of time."