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P498 Final Results of SOLE study: Focus on patient adherence/satisfaction and their correlation with patient worries

A. Orlando*1, F. Castiglione2, A. Privitera3, C. Pagnini4, A. Contaldo5, P. Vernia6, P. Usai7, G. Bodini8, A.F. Ciccaglione9, E. Calabrese10, S. Saettone11, A. Michielan12, G. Gualberti13, M.L. Scribano14

1Ospedali Riuniti Villa Sofia Cervello, Internal Medicine, Palermo, Italy, 2Università Federico II, Gastroenterology, Napoli, Italy, 3Azienda Ospedaliera per l'Emergenza "Cannizzaro", Gastroenterology, Catania, Italy, 4Ospedale S. Andrea, Gastroenterology, Roma, Italy, 5Università di Bari, Gastroenterology, Bari, Italy, 6Università La Sapienza, Gastroenterology, Roma, Italy, 7Azienda Ospedaliero Universitaria di Cagliari, Gastroenterology, Cagliari, Italy, 8Ospedale San Martino, Gastroenterology, Genova, Italy, 9Ospedale Civile "S. Spirito", Gastroenterology, Pescara, Italy, 10Università degli Studi di Roma "Tor Vergata", Gastroenterology, Roma, Italy, 11Ospedale S.S. Trinità, Gastroenterology, Borgomanero , Italy, 12Azienda Ospedaliero-Universitaria di Padova, Gastroenterology, Padova, Italy, 13AbbVie srl, Medical Direction, Campoverde, Italy, 14Azienda Ospedaliera San Camillo-Forlanini , Gastroenterology, Roma, Italy


A large "Survey on Quality Of Life in Crohn's PatiEnts (SOLE)" was conducted in Italy on subjects with active Crohn's disease (CD) with the aim of assessing health-related QoL over a 12-month period and determining the relationship between QoL and disease activity, patient satisfaction and treatment adherence.


Adults with active moderate-to-severe CD [Harvey Bradshaw Index (HBI) ≥ 8] were prospectively recruited in 38 IBD centres, over a 12-month observation period (2012-2013), with visits scheduled at baseline, and at 3, 6 and 12 months. Treatment adherence, disease-related worries, and treatment satisfaction were assessed with Medication Adherence Report Scale (MARS-5), Rating Form of Inflammatory Bowel Disease Patient Concerns (RFIPC) and Treatment Satisfaction Questionnaire for Medication (TSQM) respectively. Patients were categorized as fully or partially adherent (MARS score =25 or <25 respectively). For data analysis we used a multilevel mixed-effect linear regression model taking into account the visits and either HBI and therapeutic management or MARS and RFIPC.


552 patients with active CD (51% males, mean age 41.3 ± 13.7 y, range 18-84 y) were recruited and showed a remarkable mean HBI score reduction (from 10.3 at baseline to 4.4 at 12 months). The HBI reduction was related to biologic drugs use (adalimumab, p=0.012; infliximab, p=0.004) and follow-up visits progression (p<0.001). Mean (±SD) MARS score at baseline was 22.7 ± 4.2; it remained stable during the study (23.3 ± 3.5, 23.6 ± 3.1, and 23.5 ± 3.2 at 3, 6, 12 months respectively). Patients with full adherence (=25) represented 44,4% of the total population at baseline and gradually increased through the study (57.5% at 12 months). Mean RFIPC total score in patients with high adherence was significantly lower than in patients with low adherence (p<0.001) in all the study visits. This was confirmed for each RFIPC subdomain score: [body stigma (p<0.001), complications (p=0.002), sexual intimacy (p<0.001), and impact of disease (p<0.001)]. Mean TSQM score increased from 50.1 at baseline to 59.2 at 12-month visit (p=NS) and was significantly associated with a reduction of the mean RFIPC total score, and withall its subdomain scores (p<0.001 for all, calculated with Pearson's correlation coefficient).


SOLE is the first study so far to have evaluated Italian CD patients adherence, and it is one of the largest Italian observational study in this field. During SOLE, the disease activity decrease was significantly affected by visit progression and biologic drugs use. Fully adherent patients were significantly less worried about their disease than those with low adherence.