Background Adalimumab is effective in the treatment of Crohn's disease. We have already reported data on the efficacy of adalimumab in 110 steroid-dependent patients. At the end of the study 90 patients (64.5%) maintained clinical remission. Aims To assess efficacy and safety of adalimumab after 6 years in patients of the original cohort who responded to treatment. Methods The present study is an extension of the published paper on 90/110 patients. We report results on clinical remission and safety of 6 year maintenance therapy with adalimumab. Results Of the original cohort 90 patients completed the study, 17 were lost to follow-up and 3 died. At the end of follow-up (74.16 ± 10.3 months) 37/90 patients (41%) maintained clinical remission. Of these, 32 (86%) continued adalimumab and 5 (13%) discontinued treatment due to clinical remission and mucosal healing. Of the remaining 53/90 patients, 47 (52%) discontinued adalimumab due to clinical failure and 6 (7%) to adverse events. We obtained endoscopy data in 31/32 patients in clinical remission continuing adalimumab: 11 (36%) did not improve, 6 (19%) worsened, 14 (45%) improved. At univariable analysis no variables were related to treatment outcome. Conclusions This “real life” prospective study shows that adalimumab is a long-term effective and safe maintenance treatment in steroid-dependent Crohn's disease patients.

Orlando A., Renna S., Mocciaro F., Cappello M., Giunta M., Mendolaro M., et al. (2016). Six year adalimumab efficacy in steroid-dependent Crohn's disease patients: A prospective single-center real life study [10.1016/j.dld.2016.07.019].

Six year adalimumab efficacy in steroid-dependent Crohn's disease patients: A prospective single-center real life study

Orlando A.
;
Renna S.
Membro del Collaboration Group
;
Giunta M.;Mendolaro M.;Rizzuto G.;Orlando E.;Affronti M.;Craxi A.
Membro del Collaboration Group
;
Cottone M.
Supervision
2016

Abstract

Background Adalimumab is effective in the treatment of Crohn's disease. We have already reported data on the efficacy of adalimumab in 110 steroid-dependent patients. At the end of the study 90 patients (64.5%) maintained clinical remission. Aims To assess efficacy and safety of adalimumab after 6 years in patients of the original cohort who responded to treatment. Methods The present study is an extension of the published paper on 90/110 patients. We report results on clinical remission and safety of 6 year maintenance therapy with adalimumab. Results Of the original cohort 90 patients completed the study, 17 were lost to follow-up and 3 died. At the end of follow-up (74.16 ± 10.3 months) 37/90 patients (41%) maintained clinical remission. Of these, 32 (86%) continued adalimumab and 5 (13%) discontinued treatment due to clinical remission and mucosal healing. Of the remaining 53/90 patients, 47 (52%) discontinued adalimumab due to clinical failure and 6 (7%) to adverse events. We obtained endoscopy data in 31/32 patients in clinical remission continuing adalimumab: 11 (36%) did not improve, 6 (19%) worsened, 14 (45%) improved. At univariable analysis no variables were related to treatment outcome. Conclusions This “real life” prospective study shows that adalimumab is a long-term effective and safe maintenance treatment in steroid-dependent Crohn's disease patients.
http://www.elsevier.com/wps/find/journalbibliographicinfo.cws_home/623449/description#bibliographicinfo
Orlando A., Renna S., Mocciaro F., Cappello M., Giunta M., Mendolaro M., et al. (2016). Six year adalimumab efficacy in steroid-dependent Crohn's disease patients: A prospective single-center real life study [10.1016/j.dld.2016.07.019].
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/10447/401599
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