Background Pivotal trials have shown that ustekinumab (UST) is effective in ulcerative colitis (UC). However, the population included in these trials do not always represent the cohort of patients treated in the “real world”. In this study, we aimed to describe the effectiveness and safety of UST in a clinical cohort of patients with UC Methods We performed a multi-center cohort study and included patients with active UC starting UST. Variables collected included demographics, previous and current UC medications, disease activity (measured using partial and endoscopic Mayo score [PMS and EMS]) at 8 weeks, 6 months and end of follow-up. We also abstracted UST drug level and anti-UST antibodies (AUA), albumin and C-reactive protein levels. Primary outcomes were clinical response at week 8 defined as a reduction of 3 points in the PMS or PMS<2. Secondary outcomes were clinical remission defined as a PMS <2 and endoscopic remission defined as a MES ≤1, and the development of an adverse event (AE) attributed to UST. Results Ninety-five patients were included with a median age of 42 years (IQR:32-57) and 53 (56%) were female. Median follow-up was 5 months (IQR:2.2-7.4). Only 4 (4.3%) were naïve to biologics or tofacitinib and 62 (66%) had previous exposure to at least 2 other biologics. No variables were found to be associated with response at week 8 (Figure 2). Those patients who responded at week 8 had higher median albumin levels vs those who did not (median of 4.4 [IQR: 4.1-4.6] vs 4.1 g/dL [IQR:3.8-4.3]; p=0.02). There were no differences in baseline CRP levels (1mg/dL [IQR:0.6-2.8] vs 0.6 mg/dL [0.3-1.5]; p=0.06). Among the 33 patients who had follow-up endoscopic assessment, 7 (21.2%) had achieved endoscopic remission and 4 (12%) achieved histologic remission. Median UST level was 4.1 mcg/ml (IQR:2.5-5.1) and no patients had detectable AUA. Five patients underwent colectomy (5.3%). Only 6 patients (6.6%) presented with an AE (all minor that included, rash, headaches, arthralgias and infection). Conclusion In a population enriched with refractory UC, UST was well tolerated and induce response and remission in a significant number of patients. The rate of response was lower in obese patients and those with extensive colitis but was not associated with previous exposure to biologics and/or tofacitinib. Larger studies with a longer follow-up are warranted. Figure 1: Rates of clinical response and remission in patients with UC receiving ustekinumab Figure 2: Association between several baseline characteristics and response to ustekinumab in UC
Table 1. Study and patient characteristic charting form Study Intervention Study design Population Age Outcomes Results Sharara et al., 2017 Mobile App RCT, Colonoscopist blinded 160 .18 Primary outcome: Adherence with instructions No statistical difference in overall adherence (p50.40) or bowel cleanliness (p50.68). Walter et al., 2020 Mobile App RCT, Colonoscopist blinded 500 .18 Primary outcome: Quality of preparation (BPPS) Secondary outcome: Compliance with diet and laxatives. Discomfort from the prep. App compare to standard instruction; BPPS (7.6 6 0.1) vs (6.7 6 0.1) (p, 0.0001), Insufficient bowel prep 8% vs 17% (P 5 .0023), Adenoma detection rate 35% vs 27% in controls (P 5 .0324), Adherence and decreasing level of discomfort (p, 0.0001). Denizard-Thompson et al. 2020 Mobile App RCT 408 .18 Primary outcome: Chart-verified completion of a CRC screening test within 24 weeks Secondary outcome: Benefits, barriers to screening, selfefficacy, ability to state a screening decision, intent to screen within 30 days and patient/provider discussion mPATH-CRC arm vs control arm; completing of CRC screening 30% vs. 15%, Ordering the test 69% vs. 32%,
Methods: 15,552 patients with self-reported IBS downloaded a 42-session mobile app-delivered GDH program 'Nerva'. The first 7 sessions were free. Overall and individual gastrointestinal symptoms were assessed at baseline and 6 weeks after starting the program, using a 100-mm visual analogue scale (VAS). Psychological outcomes were measured using the PHQ4, which is validated to categorise likelihood psychological distress into normal (0-2), mild (3-5), moderate (6-8) and severe (9-12). Data were parametric and presented per protocol. Results: Out of 15,552 users, 3101 completed the program. Of those who completed the program, overall gastrointestinal symptoms improved by 28 mm, to a level that would be considered meaningful clinically (mean 67 mm to 39 mm; p, 0.001 t-test). In the those who did not complete the program, overall gastrointestinal symptoms still significantly improved, but to a smaller magnitude (68 mm to 58 mm). Similar results were seen with individual symptoms. Linear regression analysis indicated that users who completed the program were more likely to respond (p, 0.001). Total adherence rate was generally low, with only 20% of users completing the program. However, users who were referred to Nerva by a HCP were statistically more likely to complete the program (24%) compared with those self-referred (19%) (OR 1.3; p, 0.001 logistic regression). HCP referral did not alter gastrointestinal symptom response (p50.024). Users who completed the program were more likely to improve psychologically (mean Δ3, shifting from moderate to mild distress, vs 1, p, .001). Conclusion: App-delivered GDH improves overall and individual gastrointestinal symptoms. Users who complete the program report greater improvement in psychological outcomes. HCP referral is a positive predictor of program completion, but does not alter rates of efficacy.
Figure 1. showing increasing trends of adenoma detection on screening colonoscopy from 2019 to 2021Table 1. Demographic, socioeconomic factors associated with adenoma detection on screening colonoscopy No Adenoma (N518057) Adenoma (N55259) p-value Adjusted OR (95% CI) p-value Age (mean 6 sd) 59.1 6 8.9 60.6 6 9.0 , 0.001 NA Age .565 4877 (27%) 1741 (33.1%) , 0.001 1.7 (1.6 -1.7) , 0.001 Sex Male 51 7873 (43.6%) 2896 (55.1%) , 0.001 REF Female 10184 (56.4%) 2363 (44.9%) 0.65 (0.62 -0.67) , 0.001 Race 0.003 Caucasians 13621 (75.4%) 4054 (77.1%) REF African Americans 3145 (17.4%) 810 (15.4%) 0.9 (0.85 -0.96) 0.001 Others 1291 (7.1%) 395 (7.5%) 0.97 (0.89 -1.05) 0.54 Insurance type , 0.001 Medicare 4033 (22.3%) 1419 (27%) 1.04 (0.98 -1.09) 0.15 Medicaid and other public 1111 (6.2%) 356 (6.8%) 0.87 (0.8 -0.94) 0.001 Private 11297 (62.6%) 3067 (58.3%) REF No insurance 1616 (8.9%) 417 (7.9%) 0.76 (0.71 -0.82) , 0.001 Education level (% high school grads in zip code) 0.008
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