Management of Crohn's disease (CD) of the ileoanal pouch with infixinab

Abstract

Background: 6-Thioguamne (6-TG) may offer an ahernative in immunosuppression for chronic active Crohn's disease (CD) Recently, we showed 6-TG to be rapidly effective in remi~ion induction therapy (Herr/inger etal . , AP&fff in press). To evaluate its role in remission maintenance we conducted a tbilc~w-up study to investigate the long-term efficacy, safety and tolerance of 6-TG in chi'nnic active CD. Patients and Methods: 16 patients who had succes~sb.llly recmved 6-thiognanine tor remission induction were enrolled. Reasons [br immunosuppressiw therapy were steroid-dependency (n = 10), steroid-reti'act oriness (n = 6), and/or intoleance (n = 6) or ret}actoriness (n = 1 ) to azathioprine (Aza), respectively. After the remission induction therapy of six months patients were treated for another st',: months with a &fly dose of 20 to 40rag 6-TG. Primary outcomes were clinical remission (CDAI< 150) and complete steroid-reduction in steroid-dependent patients at month 12. Laboratory controls of white blood count and liver enzymes as well as measurement of erythmcyte 6thioguanine nucleotides (TGN) were performed regulanly Results: Afier 12 months of treatmer~t 14/16 patients were in clinical remission. All but three patients were completely weaned from systemic steroids. At month 12 four of 16 patients were successfnlly switched to ~.a, one patient received methotrexate and relapsed. Three patients refused further treatment and two of them relapsed four months later. Eight patients are still on 6-thiognanine with a daily dose of 10 to 20mg and in remission. Adverse events during maintenance therapy included photosensitivity (n:l), minor viral infections (1), headache (4) and mild alopecia (1) One patient developed elevated liver enzymes, splenomegaly and thrombocytopenia. This patient recovered within 24 weeks after stopping 6-thinguanine. Conclusimrs: 6-Thingnamne appears to be very effective in remission maintanance therapy in chronic active Cmhn's disease Unfortunately', long-term bepatotoxlciy seems to be an unpredictable and potentially severe prohlem Tberetore, fi'om our point of view to date 6-TG can not be recommended tbr general use outside controlled trials.