ORIGINAL ARTICLE Adalimumab in Steroid-dependent Crohn’s Disease Patients: Prognostic Factors for Clinical Benefit Ambrogio Orlando, MD,* Sara Renna, MD, PhD,* Filippo Mocciaro, MD, PhD,* Maria Cappello, MD, † Roberto Di Mitri, MD, ‡ Claudia Randazzo, MD, † and Mario Cottone, Prof* Background: Corticosteroids are effective in the treatment of Crohn’s disease but some patients relapse during tapering or after discontinua- tion. We report data on efficacy and prognostic factors of response of adalimumab in steroid-dependent patients. Methods: In all, 110 steroid-dependent patients were treated with adalimumab (80/40 or 160/80 mg every other week followed by 40 mg every other week). Clinical remission was defined as steroid discontinuation without symptomatic recurrence and clinical response as the reduction or maintenance of the initial Crohn’s Disease Activity Index (CDAI) value reducing steroid dosage but without its discontinuation at week 6 and at the end of follow-up. Results: At week 6, 91% of patients 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 maintained the clinical benefit (remission: 64.5%, response: 16.4%). At univariate analysis four variables were associated with remission at week 6: age of patients <40 years at baseline, no previous history of surgery, inflammatory pattern, and higher induction regimen. At multivariate analysis only higher induction regimen was related to remission at week 6. At the end of the follow-up, none of the variables were associated with remission. None of the variables were related to response at 6 weeks and at the end of follow-up. Adalimu- mab was well tolerated. Conclusions: This study shows that adalimumab is a powerful and safe weapon for steroid discontinuation in patients with steroid-dependent Crohn’s disease. Higher induction regimen dosage is the better therapeutic choice for achieving clinical remission with low risk of clinical relapse. (Inflamm Bowel Dis 2012;18:826–831) Key Words: steroid-dependent Crohn’s disease, adalimumab, biologics, inflammatory bowel disease C orticosteroids (CS) have been proved effective in the treatment of active Crohn’s disease (CD) but some patients who initially respond to CS relapse during CS tapering or early after CS discontinuation and require rein- stitution of CS therapy. Prolonged steroid response has been reported in 44% of patients with CD, steroid depend- ency in 36%, and steroid refractory in 20%. 1 In the second European evidence-based consensus on the diagnosis and management of CD, 2 experts defined patients with steroid-dependent disease as those unable to reduce steroids below the equivalent of prednisolone 10 mg/ day (or budesonide below 3 mg/day) within 3 months of start- ing steroids, without recurrent active disease, and those who have had a relapse within 3 months of stopping steroids. In steroid-dependent and refractory patients immunosup- pressant 3 and biological therapies 4–6 are the treatment of choice to maintain steroid-free clinical remission. 2 Adalimumab (ADA), a subcutaneously administered, recombinant, fully human anti-tumor necrosis factor alpha (TNF-a) is effective for induction 7 and maintenance 5 therapy of patients with moderate to severe CD. However, in the CHARM study 5 steroid-sparing effect was evaluated only in a subgroup of patients treated with CS at the baseline visit (44%). In clinical studies the ability to reduce the steroid dose was assessed as the ability to follow a predefined steroid tapering regimen or the ability to reduce ste- roid dose to <10 mg/day while maintaining remission. In order to evaluate the efficacy and safety of ADA in a well-defined population of steroid-dependent CD patients we carried out a study in a large prospective cohort of patients treated at three centers dedicated to the care of patients with inflammatory bowel disease (IBD). Our aim was also to identify possible prognostic factors of remission and response. MATERIALS AND METHODS Patient Characteristics This prospective observational study included 110 ste- roid-dependent CD patients (male 60), about 5% of the total Received for publication June 8, 2011; Accepted July 6, 2011. From the *DI.BI.MIS., Division of Internal Medicine ‘‘Villa Sofia-V. Cervello’’ Hospital, University of Palermo, Palermo, Italy, † DI.BI.MIS., Department of Gastroenterology and Hepatology, University of Palermo, Palermo, Italy, ‡ Gastroenterology unit, Civico-A.R.N.A.S. Hospital, Palermo, Italy. Reprints: Ambrogio Orlando, Piazza Mameli no. 1, Palermo, Italy (e-mail: ambrogiorlando@gmail.com). Copyright V C 2011 Crohn’s & Colitis Foundation of America, Inc. DOI 10.1002/ibd.21835 Published online 11 August 2011 in Wiley Online Library (wileyonlinelibrary.com). Inflamm Bowel Dis  Volume 18, Number 5, May 2012 826