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Remicade accelerated induction reduces early colectomy
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An accelerated Remicade induction strategy reduced the need for early colectomy in patients with acute severe ulcerative colitis, according to findings from a retrospective analysis performed in Ireland.
Aiming to determine whether an accelerated Remicade (infliximab, Janssen) regimen would reduce colectomy rates during induction and 2 years follow-up in patients with acute severe UC, researchers retrospectively reviewed 50 consecutive patients (median age, 36 years; 27 men) treated at an academic center for steroid-refractory acute severe UC from September 2005 to September 2014. The standard dosing group (n = 35) received 5 mg/kg infliximab at 0, 2 and 6 weeks and then every 8 weeks. The accelerated dosing group (n = 15) received three induction doses timed based on clinical need within a median of 24.5 days (interquartile range [IQR], 21-29), which was significantly shorter compared with the standard dosing group’s median 43 days (IQR, 41-44; P < .0001).
In the standard dosing group, 63% of patients completed induction compared with 93% of the accelerated dosing group (P = .04). Colectomy rates during induction were 37.1% in the standard dosing group compared with 6.7% in the accelerated group (P = .039). The standard dosing regimen was associated with shorter time to colectomy (P = .04). Colectomy rates were comparable between groups during the follow-up period. Independent factors associated with successful induction included serum albumin level when treatment began (RR = 0.84; 95% CI, 0.75-0.95) and the accelerated dosing regimen (RR = 0.11; 95% CI, 0.03-0.83).
“Despite the limitations, findings from this study suggest the need for further evaluation with prospective comparative studies of the effect of an [accelerated dosing] strategy, determined by [C-reactive protein], perhaps in combination with [infliximab] levels,” the researchers wrote. “Observational studies such as ours provide useful clinical data to shape future treatment algorithms with a tailored dosing approach in acute severe disease when tumor necrosis factor (TNF) levels are at their highest. We believe an [accelerated dosing infliximab] induction should be considered in all patients with steroid-refractory [acute severe] UC who develop rebound inflammation before their next scheduled [infliximab] dose.”
According to survey results shared in an accompanying editorial by Hans. H. Herfarth, MD, PhD, from University of North Carolina, Chapel Hill, Gerhard Rogler, MD, PhD, from the University of Zurich in Switzerland and Peter D. R. Higgins, MD, PhD, MSc, from University of Michigan, Ann Arbor, only 24% of surveyed physicians used the standard dosing regimen for induction of remission in hospitalized patients with severe UC. “There appears to be a sub rosa movement in the inflammatory bowel disease community to try accelerated infliximab in severe UC, and the Gibson study provides data to support this approach,” they wrote.
“At this point, it is critical to the field to conduct randomized multicenter clinical trials to identify the optimal dosing regimen for anti-TNF therapy in severe inpatient UC, and to identify the best monitoring strategies, evaluating the value of serum [C-reactive protein] levels, serum albumin levels, and serum and fecal infliximab levels.” – by Adam Leitenberger
Disclosure: The researchers report no relevant financial disclosures. Herfarth, Higgins and Rogler report no relevant financial disclosures.
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