August 19, 2015
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Early response to Remicade predicts long-term benefit in patients with ulcerative colitis

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The long-term efficacy of Remicade in patients with moderate-to-severe ulcerative colitis is associated with early response to treatment, according to study results.

Researchers performed a retrospective cohort study of 213 consecutive patients with ulcerative colitis who were refractory to or dependent on steroids and were treated with induction and scheduled maintenance Remicade (infliximab, Janssen) therapy at Mount Sinai Hospital in Toronto, Canada, from March 2001 to December 2012.

At year 1, cumulative likelihood of steroid-free remission was 39% (95% CI, 32%-47%), cumulative likelihood of infliximab failure was 31.7% (95% CI, 25.3%-38.1%) and cumulative likelihood of colectomy was 19.2% (95% CI, 13.8%-24.6%). At 5 years, these cumulative probabilities were 14% (95% CI, 9%-22%), 55.6% (95% CI, 46.9%-64.4%) and 37.4% (95% CI, 28.7%-46%), respectively. Long-term steroid-free remission at 5 years was 36% (95% CI, 30%-43%) when a sensitivity analysis factoring in data from the last visits of patients with incomplete follow-up was performed.

Responders who achieved clinical remission before maintenance therapy were more likely to achieve steroid-free remission at 1 year (adjusted OR = 4.5; 95% CI, 1.75-11.53), while those who needed dose intensification during year 1 were less likely to achieve steroid-free remission at 1 year (aOR = 0.28; 95% CI, 0.11-0.67) and more likely to fail treatment after 1 year (aHR = 2.57; 95% CI, 1.14-5.81). Multivariate analysis showed older age was predictive of lower likelihood of steroid-free remission at 1 year (aOR = 0.78; 95% CI, 0.61-0.99, per decade of age increase) and longer disease duration at initiation of infliximab therapy was predictive of increased likelihood of steroid-free remission at 1-year (aOR = 2.1; 95% CI, 1.2-3.5, per decade of duration increase).

“In summary, we found that close to half of all patients with steroid-refractory or steroid-dependent [ulcerative colitis] of moderate-to-high disease activity who are treated with scheduled [infliximab] at an IBD center can be maintained on [infliximab] for at least 5 years, although a smaller proportion of patients achieve long-term [steroid-free remission],” the researchers concluded. “Patients who achieve a rapid and stable early response to [infliximab] therapy seem to achieve the greatest long-term benefit with this agent. Conversely, patients who have a suboptimal early response to [infliximab] seem to have a less favorable long-term course, particularly those who require repeated dose intensification within the first year, and such patients may be best considered for early alternative therapies.” – by Adam Leitenberger

Disclosure: The researchers report no relevant financial disclosures.