P061 - Reduction in extraintestinal manifestations of Crohn's disease is associated with improvements in patient-reported and disease activity outcomes in patients treated with adalimumab

Abstract

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S35 P061 Reduction in extraintestinal manifestations of Crohn’s disease is associated with improvements in patient-reported and disease activity outcomes in patients treated with adalimumab W. Reinisch1 *, R. Lofberg2, E. Louis3, A.P. Yu4, J. McHale4, N. Beaulieu4, P. Mulani5, J. Chao5. 1Medical University of Vienna, Vienna, Austria, 2Karolinska Institutet, Stockholm, Sweden, 3University of Liege, Liege, Belgium, 4Analysis Group, Boston, MA, USA, 5Abbott, Abbott Park, IL, USA Introduction: Adalimumab is approved for treatment of adults with active Crohn’s disease (CD) and has been shown to induce and maintain remission in patients who have had an inadequate response to conventional therapy. CD is associated with extraintestinal manifestations (EIMs) in approximately 25% of patients.1 The objective of this analysis was to assess the impact of EIMs on patient-reported outcomes (PROs) and disease activity in patients with CD. Methods: The Crohn’s Patients Treated With Adalimumab: Results of a Safety and Efficacy Study (CARE) enrolled 945 patients with moderate to severe CD (Harvey Bradshaw Index [HBI] score 7). CARE was a multicenter, open-label, European, Phase IIIb trial evaluating the efficacy and safety of adalimumab in a large population of patients whose treatment approximated usual clinical practice. Outcomes included Short Inflammatory Bowel Disease Questionnaire (SIBDQ), 4 components of the Work Productivity and Activity Impairment (WPAI) questionnaire (total activity impairment [TAI], total work productivity impairment [TWPI], absenteeism, and presenteeism), and HBI. Presence of EIMs was assessed clinically as part of the baseline physical examination, and healing and development of new EIMs were evaluated at each scheduled visit at 2, 4, 8, 12, and 20 weeks after initiation of adalimumab therapy. A comparison of patients with and without EIMs at baseline was conducted to assess differences in demographics, PROs, and CD-related outcomes. Multivariate regression analyses were used to assess the impact of a reduction in EIMs on outcomes at Week 20, controlling for baseline characteristics. Results: At baseline, 52.6% (n = 497) of patients reported having 1 EIM, with an average of 1.4. EIMs reported in the patient population included erythema nodosum, pyoderma gangrenosum, eye involvement, arthritis, arthralgia, sacroiliitis, ankylosing spondylitis, hepatic disease, thrombosis, and nephrolithiasis. Patients with EIMs had more disease activity (ie, greater HBI), poorer SIBDQ, more impairment in daily activity as measured by TAI, and more CD-related symptoms at baseline than those without EIMs (p < 0.001). Patients who had longer duration of CD had, on average, more EIMs at baseline. Of the 497 patients with EIMs at baseline, 63.4% (n = 315) experienced a decrease in the number of EIMs at Week 20 of treatment with adalimumab. Regression analysis demonstrated that a decrease in the number of EIMs at Week 20 was a statistically significant predictor of improvements in patient-reported and disease activity outcomes, after controlling for baseline characteristics (table). Coefficients of reductions in number of EIMs in predicting HRQOL and disease activity scores at Week 20 in CARE: Results of linear regression analysis SIBDQ estimate 2.40**