Epidemiological features and disease-related concerns of a large cohort of Italian patients with active Crohn's disease

Alessandro Armuzzi, Gabriele Riegler, Federica Furfaro, Monia Baldoni, Francesco Costa, Manuela Fortuna, Gaetano Iaquinto, Pietro Paese, Claudio Papi, Fabrizio Bossa, Gian Eugenio Tontini, Sara Di Fino, Giuliana Gualberti, Rocco Merolla, Fernando Rizzello

Research output: Contribution to journalArticlepeer-review


Background-Aims: The SOLE study was conducted on a large cohort of Italian patients with moderate-severe Crohn's disease (CD) to assess epidemiological and disease characteristics and their correlation with disease-related worries, treatment satisfaction and adherence, workability. Methods: The following tools were used over 12 months to assess: • disease-related worries: Rating Form of Inflammatory Bowel Disease Patient Concerns, • impact on workability: Work Productivity and Activity Impairment-CD, • satisfaction: Treatment Satisfaction Questionnaire for Medication, • adherence: Medication Adherence Rating Scale. Results were correlated with demographic and clinical variables with linear regression models. Results: 552 patients with active CD (51% men) were recruited. Higher worries were having an ostomy bag and undergoing surgery. Variables associated with a higher RFIPC score included female sex, higher disease activity, lower treatment adherence (p < 0.001), previous surgical treatments (p = 0.003). 60% of patients claimed difficulties with activities of daily living. Lower VAS scores were reported by patients with disease duration >6years; treatment satisfaction/adherence was higher with anti-TNF-α treatment. Decreased hospitalizations during follow-up and improved workability/daily activities occurred with adalimumab, infliximab, azathioprine (p < 0.001). Conclusion: Worries included having an ostomy bag, undergoing surgery, developing cancer: conditions significantly associated with worsened disease activity and low treatment adherence. Higher treatment adherence scores/greater workability improvements were observed in patients treated with anti-TNF-α agents.

Original languageEnglish
JournalDigestive and Liver Disease
Publication statusAccepted/In press - Jan 1 2019


  • Crohn's disease
  • Patient's concerns
  • Quality of life
  • Treatment adherence and satisfaction

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology


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