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Multiple Remicade doses produce better colectomy-free survival in ulcerative colitis
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Using multiple doses of Remicade as salvage therapy for acute severe ulcerative colitis produced better colectomy-free outcomes for patients at 3 months, according to results of a meta-analysis.
However, Peter P. De Cruz, MBBS, PhD, FRACP, of the department of gastroenterology at Austin Health in Australia, and colleagues wrote that the drug’s true benefit might be masked because it is used more often in patients with worse disease severity.
“Despite being used for more than 15 years, the optimal [Remicade; infliximab, Janssen] dose strategy in [acute severe ulcerative colitis (ASUC)] is unknown, due to the infrequency of this life-threatening condition and the difficulty of performing well-constructed [randomized controlled trials],” the researchers wrote. “[Infliximab] salvage in ASUC has evolved from 5 mg/kg single-dose induction to high-dose and short-interval therapy based on studies with vastly different clinical settings and clinician experiences.”
Investigators searched the literature for studies that reported steroid-refractory ASUC treated with infliximab salvage and categorized infliximab use by dose, dose number and schedule. Colectomy-free survival at 3 months served as the primary endpoint. The study’s analysis comprised 2,158 cases.
Colectomy-free survival with infliximab salvage was 79.7% (95% CI, 75.48%–83.6%) at 3 months and 69.8% (95% CI, 65.7%–73.7%) at 12 months. The survival rate at 3 months was superior with multiple 5 mg/kg doses compared with single-dose induction (OR = 4.24; 95% CI, 2.44–7.36).
De Cruz and colleagues found that dose intensification or acceleration were not associated with improved outcomes over standard dosing, which they said was contrary to current trends in clinical practice.
“We found that dose-intensified strategies were used in patient groups with an overall higher c-reactive protein and lower albumin, biochemical profiles indicating greater disease severity and associated with an increased likelihood of colectomy,” they wrote. “Although these biochemical differences should be interpreted with caution due to the risk of aggregation bias of mean data, this may mask the true benefit of dose intensification and its potential effect of attenuating the rate of colectomy in high-risk patients. This indicates the need for clinical trials to control for these parameters of disease severity in the future.” – by Alex Young
Disclosures: De Cruz reports serving as a consultant, advisory board member or speaker for AbbVie, Baxter, Ferring, Janssen, Shire and Takeda and receiving research support from Ferring, Janssen and Shire. Please see the full study for all other author’s relevant financial disclosures.
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