RESUMO
Background: Ustekinumab was approved in 2016 for the treatment of moderate-severe Crohn's disease (CD). Clinical trials and real-world studies have suggested ustekinumab to be a safe and effective treatment; however, studies to date infrequently use imaging techniques to predict response to biologics in CD. Objectives: We assessed the 2-year real-world effectiveness and safety of ustekinumab in a tertiary CD cohort with the use of novel imaging techniques. Design: Retrospective cohort study. Methods: Retrospective data were collected between 2016 and 2021. Study end points included ustekinumab persistence, biological and/or clinical response and remission at 12, 18 and 24 months. Statistical analysis included demographic and inferential analyses. Results: In all, 131 CD patients [57.3% female, median age of 26.0 (21.0-37.0)] were included. Patients were non-bio naïve, and the majority received ustekinumab as third- or fourth-line treatment. At 24 months, 61.0% (80/131) persisted with ustekinumab [52.7% (69/131) steroid free]. Clinical response was reported in 55.2% (37/67), clinical remission in 85.7% (57/67), biological response in 46.8% (22/47) and biological remission in 31.9% (15/47) of patients at 24 months. The low outcome numbers were attributable to missing data. Improvements in routine disease markers, including C-reactive protein and Harvey-Bradshaw Index, were also reflected in magnetic resonance imaging-derived disease scores. The presence of penetrating CD, an -ostomy and sarcopenia were all predictors of poorer ustekinumab outcomes (p < 0.05). Conclusion: Ustekinumab is effective in non-bio-naïve CD patients with non-stricturing, non-penetrating disease with an unremarkable safety profile but may be less effective in those with penetrating disease, -ostomies and sarcopenia.
RESUMO
The coronavirus disease 2019 pandemic may have affected the quality of clinical consultations. The objective was to use 10 proposed quality indicator questions to assess outpatient consultation quality; to assess whether the recent shift to telemedicine during the pandemic has affected consultation quality; and to determine whether consultation quality is associated with satisfaction and consultation outcome. A cross-sectional study was used to survey clinicians and patients after outpatient consultations (1 February to 31 March 2021). The consultation quality score (CQS) was the sum of 'yes' responses to the survey questions. In total, 78% (538/690) of consultations conducted were assessed by a patient, clinician, or both. Patient survey response rate was 60% (415/690) and clinician 42% (291/690). Face-to-face consultations had a greater CQS than telephone (patients and clinicians < 0.001). A greater CQS was associated with higher overall satisfaction (clinicians log-odds: 0.77 ± 0.52, p = 0.004; patients log-odds: 1.35 ± 0.57, p < 0.001) and with definitive consultation outcomes (clinician log-odds: 0.44 ± 0.36, p = 0.03). In conclusion, consultation quality is assessable; the shift to telemedicine has negatively impacted consultation quality; and high-quality consultations are associated with greater satisfaction and definitive consultation outcome decisions.