INTRODUCTION: Adalimumab is effective in inducing and maintaining remission in active steroid-dependent Crohn's disease (CD). A post hoc analysis has also shown its effectiveness in perianal CD. AIMS & METHODS: The aim of this study was to evaluate the effectiveness of Adalimumab in the treatment of active perianal CD. Materials and methods: From January 2008 to May 2009, 64 consecutive patients, in a single tertiary center were prospectively followed (28f/36m, mean age 32 years, range 16-52, 8 smokers). The patients presented complex (trans or suprasphinteric, horse-shoes, multiple with or without rectal involvment) perianal fistulising disease, intolerant or resistant to immunosuppressive or secondary failure to infliximab (IFX). Treatment: After a deep surgical perineum sanitization, all patients received 160/80mg as induction dose followed by 40mg eow if responders. In case of loss of response, a weekly treatment was performed. Immunosuppressive therapy was suspended at the start of treatment, steroid dose was reduced of 2.5 mg/week after the induction phase.Definitions: remission= complete closure of the fistula assessed with Evaluation Under Anesthesia; Response= lack of drainage of purulent material at surgical evaluation. RESULTS: Results: Patients population: n = 64, 28 naive, 36 IFX failure, 42/64 colonic disease, 22/64 rectal involvement, 38/64 (59%) treated with azathioprine, 4/64 (6.2%) with methotrexate , 22/64 (34%) with steroids; media CDAI at baseline 310 (range 49-596), median IBDQat baseline 120 (range 58-208)]. At week 8, 8/64 patients (12,5%) were in remission and 20/64 (31%) responded; at week 24, 14/64 patients (22%) were in remission and 30/64 (47%) had a clinical response; at week 52, 32/52 patients (62%) were in remission and 38/52 (73%) had a clinical response; at week 76, 36/46 patients (78%) were in remission and 40/46 (87%) had a clinical response, assessed surgically. The effect was independent of the past use of IFX. Three patients loss response and moved to a temporary loop-ileostomy; 14/64 (22%) moved to a weekly treatment. No serious adverse events were registered. CONCLUSION: The data obtained in everyday clinical practice confirm the effectiveness of adalimumab in the treatment of perianal CD and the safety and stability of efficacy over time
Paolo Gionchetti, Fernando Rizzello, Rosy Tambasco, Giulia Straforini, Ramona Brugnera, Carlo Calabrese, et al. (2010). Adalimumab in the Treatment of Perianal Crohn's Disease: A Single Center in 64 Patients.
Adalimumab in the Treatment of Perianal Crohn's Disease: A Single Center in 64 Patients
GIONCHETTI, PAOLO;RIZZELLO, FERNANDO;CALABRESE, CARLO;POGGIOLI, GILBERTO;LAURETI, SILVIO;CAMPIERI, MASSIMO
2010
Abstract
INTRODUCTION: Adalimumab is effective in inducing and maintaining remission in active steroid-dependent Crohn's disease (CD). A post hoc analysis has also shown its effectiveness in perianal CD. AIMS & METHODS: The aim of this study was to evaluate the effectiveness of Adalimumab in the treatment of active perianal CD. Materials and methods: From January 2008 to May 2009, 64 consecutive patients, in a single tertiary center were prospectively followed (28f/36m, mean age 32 years, range 16-52, 8 smokers). The patients presented complex (trans or suprasphinteric, horse-shoes, multiple with or without rectal involvment) perianal fistulising disease, intolerant or resistant to immunosuppressive or secondary failure to infliximab (IFX). Treatment: After a deep surgical perineum sanitization, all patients received 160/80mg as induction dose followed by 40mg eow if responders. In case of loss of response, a weekly treatment was performed. Immunosuppressive therapy was suspended at the start of treatment, steroid dose was reduced of 2.5 mg/week after the induction phase.Definitions: remission= complete closure of the fistula assessed with Evaluation Under Anesthesia; Response= lack of drainage of purulent material at surgical evaluation. RESULTS: Results: Patients population: n = 64, 28 naive, 36 IFX failure, 42/64 colonic disease, 22/64 rectal involvement, 38/64 (59%) treated with azathioprine, 4/64 (6.2%) with methotrexate , 22/64 (34%) with steroids; media CDAI at baseline 310 (range 49-596), median IBDQat baseline 120 (range 58-208)]. At week 8, 8/64 patients (12,5%) were in remission and 20/64 (31%) responded; at week 24, 14/64 patients (22%) were in remission and 30/64 (47%) had a clinical response; at week 52, 32/52 patients (62%) were in remission and 38/52 (73%) had a clinical response; at week 76, 36/46 patients (78%) were in remission and 40/46 (87%) had a clinical response, assessed surgically. The effect was independent of the past use of IFX. Three patients loss response and moved to a temporary loop-ileostomy; 14/64 (22%) moved to a weekly treatment. No serious adverse events were registered. CONCLUSION: The data obtained in everyday clinical practice confirm the effectiveness of adalimumab in the treatment of perianal CD and the safety and stability of efficacy over timeI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
