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Effect of antibodies to infliximab on infusion reaction and clinical response in patients with fistulizing crohns disease receiving maintenance treatment with infliximab



Effect of antibodies to infliximab on infusion reaction and clinical response in patients with fistulizing crohns disease receiving maintenance treatment with infliximab



Digestive Disease Week Abstracts & Itinerary Planner : Abstract No M1598



Background: We tested all patients (pts) enrolled in the double-blind, placebo (PBO)-controlled, ACCENT II trial for antibodies (Ab) to infliximab (IFX), and compared proportion of pts with and without Ab to IFX for fistula response and infusion reactions. Methods: All pts received 5 mg/kg IFX at wks 0, 2 and 6, and were randomized to receive infusions every 8 wks (q8wks) of PBO or 5 mg/kg IFX through wk 46. Pts who received PBO or IFX maintenance therapy and lost response were eligible to receive either 5 or 10 mg/kg IFX, q8wk, starting at wk 22. When samples were negative for Ab to IFX, the results were classified as either negative (no IFX) or inconclusive (detectable IFX). Samples were collected prior to infusions at wks 0, 14, 30, and 54. Complete fistula response was closure of all fistulas. Results: Of 282 IFX-treated pts, 258 pts had analyzable samples. Ab to IFX were detected in 21.1% of PBO maintenance pts and 12.8% of 5 mg/kg IFX maintenance pts. Complete fistula response at the last observation was attained in 31.8% of pts with Ab to IFX at any time, 31.3% of pts without Ab to IFX after last treatment, and 29.1% in pts with inconclusive status after last treatment. Of pts taking concomitant medications at baseline, Ab to IFX were present in the following: 13.0% who received corticosteroids alone, 11.3% who received immunomodulators alone, 3.7% who received both, and 24.4% who received neither. Of pts tested, 51.9% were negative for Ab to IFX, but were classified as inconclusive because IFX was detectable. Serious infusion reactions were observed in 1.3% of pts who did not have Ab to IFX after last treatment. Infusion reactions leading to discontinuation were observed in 9.1% and 3.8% of pts who had Ab to IFX at any time and pts who had Ab to IFX after last treatment, respectively. Delayed hypersensitivity reactions occurred in 2.5% of pts who did not have Ab to IFX after last treatment. Conclusions: In pts receiving IFX maintenance therapy there was: (1) a lower occurrence of Ab observed in pts receiving IFX maintenance after 3-dose induction than in those receiving PBO after 3-dose induction alone; (2) a 2-3 fold higher incidence of infusion reactions leading to discontinuation of IFX in Ab positive pts, but no infusion reactions were considered serious; (3) a possible combined effect of steroids and immunomodulators on reducing Ab; and (4) no observed effect of Abs on clinical response to IFX.

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Accession: 034790231

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DOI: 10.1016/S0016-5085(03)81925-X



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