Biologics versus Immunomodulators for the Treatment of Ulcerative Colitis: A Review of Comparative Clinical Effectiveness and Cost-Effectiveness

Key Message

One good-quality RCT and one poor-quality RCT were included. Intravenous infliximab was compared to oral ciclosporin, azathioprine, and the combination of azathioprine and infliximab among moderate-to-severe ulcerative colitis patients without adequate response to corticosteroid treatment. In a pragmatic trial, there was no significant difference in quality-adjusted survival, mortality, colectomy rates, time to colectomy, lengths of hospital stay after randomization, severe adverse reactions or severe adverse effects, and quality of life measures. However, ciclosporin was associated with longer log-transformed hospital stays than infliximab. In the same trial, the UK resource use was considered. It was concluded that the total health service costs for ciclosporin were considerably lower than infliximab and ciclosporin was not less effective than infliximab. In a good-quality RCT, the combination of intravenous infliximab and oral azathioprine was significantly more effective than infliximab or azathioprine alone in corticosteroid-free remission at week 16. However, infliximab alone was not significantly more effective than azathioprine alone for the same outcome. The combination was more effective than azathioprine alone in mucosal healing at week 16, but similarly effective as infliximab. Due to limited evidence identified, further research on the clinical effectiveness and cost-effectiveness of biologics compared to immunomodulators in patients without previous exposure to these two types of drugs may be needed.