P358 Six-year adalimumab efficacy in steroid-dependent Crohn’s disease patients: a prospective ‘real-life’ study
S. Renna*1, M. Cappello2, R. Dimitri3, F. Mocciaro3, M. Mazza2, M. Giunta4, M. Mendolaro2, E. Orlando1, M. Affronti1, A. Craxì2, M. Cottone1, A. Orlando1
1”Villa Sofia-Cervello” Hospital, Division of Internal Medicine, Palermo, Italy, 2Palermo University, Department of Gastroenterology and Hepatology, Palermo, Italy, 3Arnas Civico Di Cristina Benfratelli Hospital, Gastroenterology and Endoscopy Unit, Palermo, Italy, 4”Villa Sofia-Cervello” Hospital, Division of Internal Medicine,, Palermo, Italy
Adalimumab (ADA) is effective in the induction and maintenance of remission in patients (pts) with Crohn’s disease (CD). We have already reported data on the efficacy and prognostic factors of response to ADA in 110 steroid-dependent pts. At week 6, 91% of pts have had a clinical benefit (remission: 45.5%, response: 45.5%). At the end of the follow-up (mean 14.6 months), 80.9% of responders had maintained clinical benefit (remission: 64.5%, response: 16.4%). Higher induction regimen was related to remission at week 6. At the end of the follow-up, no variable was associated with remission. Up to now, no data are available on the long-term efficacy of ADA in steroid-dependent pts.
In total, 110 treated pts were followed-up until November 2015, and the following variables were evaluated: maintenance of clinical benefit, ADA discontinuation, dose escalation, switch to another biologic, surgery, and side effects.
At the end of the follow-up (mean 74.16 ± 10.3 months) we recorded data on 90 pts: 37 pts (41%) maintained clinical remission; 32/37 (86%) were still in maintaining treatment with ADA (11/32 pts [34%] received a weekly maintaining treatment); and 5/37 pts (13%) discontinued ADA because of clinical remission and mucosal healing. Further, 47 pts (52%) discontinued ADA due to clinical failure; 20/47 pts (43%) switched to another treatment; and 27/47 pts (57%) were operated on. Moreover, 6 pts (7%) discontinued ADA because of severe adverse events; 17 pts (19%) were lost at the follow-up; and 3 pts (0.3%) died for reasons not related to ADA treatment. Amongst pts still in maintaining treatment, data on endoscopy were obtained in 31/32 pts (97%): 11/31 (36%) did not improved; 6/31 (19%) worsened; and 14/31 (45%) improved (8 pts reached mucosal healing). At univariable analysis no variables were related to the treatment outcomes.
This 6-year ‘real-life’ prospective study showed that ADA is a good and well tolerated, maintaining treatment in steroid-dependent CD but 1/3 of them needed dose escalation to maintain clinical benefit. The rate of long-term side effects is quite low.