Maintenance of remission with infliximab in inflammatory bowel disease: efficacy and safety long-term follow-up

Abstract

Aim: To evaluate the safety and efficacy of a long-term therapy with infliximab in Crohn's disease (CD) and ulcerative colitis (UC) patients retrospectively.

Methods: The medical charts of 50 patients (40 CD and 10 UC), who received after a loading dose of 3 infliximab infusions scheduled re-treatments every 8 wk as a maintenance protocol, were reviewed.

Results: Median (range) duration of treatment was 27 (4-64) mo in CD patients and 24.5 (6-46) mo in UC patients. Overall, 32 (80%) CD and 9 (90%) UC patients showed a sustained clinical response or remission throughout the maintenance period. Three CD patients shortened the interval between infusions. Eight (20%) CD patients and 1 UC patient underwent surgery for flare up of disease. Nine out of 29 CD and 4 out of 9 UC patients, who discontinued infliximab scheduled treatment, are still relapse-free after a median of 16 (5-30) and 6.5 (4-16) mo following the last infusion, respectively. Ten CD patients (25%) and 1 UC patient required concomitant steroid therapy during maintenance period, compared to 30 (75%) and 9 (90%) patients at enrollment. Of the 50 patients, 16 (32%) experienced at least 1 adverse event and 3 patients (6%) were diagnosed with cancer during maintenance treatment.

Conclusion: Scheduled infliximab strategy is effective in maintaining long-term clinical remission both in CD and UC and determines a marked steroid sparing effect. Long-lasting remission was observed following infliximab withdrawal.

Figures

Figure 1

Patients observed at 12-mo intervals (endpoints) during IFX maintenance therapy. A: CD; B: UC. Numbers in boxes refer to patients reaching each endpoint. Numbers in rhombics refer to patients not reaching 12-mo endpoints.

Figure 2

Kaplan-Meier survival curve for CD patients (n = 40). The cumulative probability of being free of relapse in CD patients with complete response was: 97.2% (CI: 91.8%-100%) at 12 mo, 90.3% (CI: 79.7%-100%) at 24 mo, 81.7% (CI: 66.9%-96.5%) at 36 mo, 73.5% (CI: 53.3%-93.7%) at 48 mo, and 61.3% (CI: 33.6%-88.9%) at 51 mo.