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November 22, 2011 Treatment of UC with Infliximab

posted Nov 21, 2011, 9:06 AM by Bonni Stahl   [ updated Nov 22, 2011, 10:57 PM by David de Gijsel ]
Matt Liakos
Matt looked at a pharma sponsered trial of Infliximab, a TNF alpha inhibitor in the treatment of refractory UC. This study took patients with moderate to severe UC as judged by the Mayo score (6-12) persistantly despite concurrent treatment with mercaptopurine, azathioprine or steroids. Patient were randomized to placebo or Infliximab infusion at 0, 2, 6 then every 8 weeks for 46 weeks in one study or 22 weeks in a second study. The study was powered for a primary end point of clinical responce or clinical remission, defined as a decrease in the Mayo score by 3 points or a 30% reduction and a decrease in rectal bleeding score by 1 point or a score of 0 or 1. The exclusion criteria excluded patients with a history of latent TB. Patients were also screened with sigmoidocpy on entry into to the trial and excluded if bx not consistent with UC. The study did not elucidate how many patients were intially screened or whether physicians determining endpoints were blinded to group assinments. In the first study the drop out rates in the control group was significant, 61% in placebo vs 37.2% in arm using 5mg and 40.2% using 10mg of infliximab. Similar drop out rates were found in the second shorter study. All drop outs were assumed to have treatment failure.

 Our Take home: Despite the flaws with the methodology, the Infliximab at 5mg improved clinical responce by 32% (absolute change). This gives a NNT of 3 patients over 8 wks! There was no significant benefit with the 10mg dose. This was with significantly less infections than we expected. There was 1 case of TB and one fatal case of Histo in the 480 patients treated with Infliximab.