AGA Abstracts Tu1847 THE IMPACT OF COGNITIVE BEHAVIORAL MINDFULNESS INTERVENTION ON THE PHYSICAL AND MENTAL CONDITION OF CROHN'S DISEASE PATIENTS AND THEIR FAMILY RELATIONS Ruslan Sergienko, Ganit Goren, Orly Sarid, Doron Schwartz, Michael Friger, Anna Nemirovsky, Ekaterina Vinogradov, Dan Greenberg, Alon Monsonego, Shirley Reggev, Selwyn H. Odes, Vered Slonim-Nevo BACKGROUND: Crohn’s Disease (CD) patients have more psychological stress than healthy persons. Such stress highlights disease symptoms, decreases satisfaction with life and impacts negatively on family relations. We hypothesize that short-term Cognitive Behavioral Mindful- ness Intervention may ameliorate disease symptoms, improve the psychological state, and enhance family relations in CD patients. METHODS: Adults with active CD were prospectively recruited and randomized to a wait-list Control Group (n=44) or Intervention Group (n= 40). Intervention group received Cognitive Behavioral Mindfulness Intervention by specially trained social workers over a 3 month period, using Skype TM . Psychological questionnaires were completed at baseline (T1) and at 3 months (T2) for both groups, as follows: Satisfaction with Life Scale (SWLS); Brief Symptom Inventory stress measure yielding a Global Severity Index (GSI); McMaster Family Assessment Device (FAD). Disease activity was assessed by the Harvey-Bradshaw Index at T1 and T2. Chi-Square, t-tests, Spearman correlations, and linear regression analyses modelling delta (T2-T1) scores of dependent variables were per- formed. Data are mean (SD) or %. RESULTS: Patient characteristics at T1 were as follows. Intervention group: mean age 34.3 (12.2) y, 33% male, 48% on biologicals, 25% on immunomodulators; Control group: 33.6 (9.64) y, 41%, 39%, 18%, respectively. Age, gender, family status, socio-economic, education, religiosity, disease duration, medication, surgeries, Montreal classification status did not differ at T1 between these Groups. In Intervention Group the T1 and T2 results were the following, respectively: HBI 8.5 (2.9) and 6.6 (3.3), p=.001, GSI 1.3 (0.7) and 1.2 (0.6), p=.051, FAD 2.1 (0.6) and 2.2 (0.5), p=.037, SWLS 18.9 (6.8) and 19.4 (6.7), p=.4. In Control Group the T1 and T2 results were: HBI 8.7 (2.4) and 4.2 (2.7), p<.01, GSI 1.1 (0.6) and 0.7 (0.4), p<.01, FAD 1.8 (0.6) and 1.6 (0.4), p=.1, SWLS 20.6 (6.7) and 23.8 (6.1), p<.01. No significant associations were detected between D(T2-T1) scores of HBI, GSI, FAD and SWLS with age, gender, family status, socio-economic, education, religiosity, disease duration, medication, surgeries and Montreal classification status at baseline. Comparisons of DT2-T1 of SWLS, HBI, GSI and FAD showed significant improvements in the Intervention Group (Table 1). Regression analysis modelling of D(T2-T1) of SWLS, GSI, HBI, FAD, while controlling for disease duration and gender, demonstrated that Group allocation was related significantly to all these dependent variables. CONCLUSION: Outcomes were overall better in the Intervention group than the Control group. The results suggest that Cognitive Behavioral Mindfulness Intervention has the potential to significantly reduce psychological stress, and to improve satisfaction with life and family relations in CD patients. Tu1848 EFFICACY OF USTEKINUMAB FOR ULCERATIVE COLITIS THROUGH 2 YEARS: RESULTS OF THE UNIFI MAINTENANCE STUDY AND LONG- TERM EXTENSION William J. Sandborn, Bruce E. Sands, Remo Panaccione, Colleen W. Marano, Christopher D. O'Brien, Hongyan Zhang, Jewel Johanns, Yiying Zhou, Laurent Peyrin-Biroulet, Tadakazu Hisamatsu, Silvio Danese Background: Ustekinumab (UST) is a mAb to IL-12/23p40 that is approved for moderate- to-severe ulcerative colitis (UC). The UNIFI maintenance study evaluated SC UST through 1 year in pts who responded to UST IV induction. Pts who completed the maintenance study could enter a long-term extension (LTE) through 220wks. Here, we report the efficacy of UST through 92wks for pts randomized in the maintenance study. Methods: Pts who were in clinical response 8wks after UST induction were randomized to SC PBO (n=175), UST 90mg q12w (n=172), or UST 90mg q8w (n=176). All pts who completed Wk44 were eligible to enter and continue in the LTE at the investigator’s discretion. Subsequent to completion of the maintenance study at Wk44, unblinding occurred and pts who were receiving PBO were discontinued from the LTE. During the LTE, pts were eligible to receive dose adjustment (q12w to q8w or q8w to q8w [sham dose adjustment]) starting at Wk56 based on investigator assessment of the their UC disease activity. Symptomatic remission (stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0) and partial Mayo remission (partial Mayo score 2) were evaluated through Wk92. Analyses of symptomatic and partial Mayo remission over time included all patients randomized in maintenance and were performed separately, with dose adjustment as part of the treatment experience (ie, not a treatment failure) and with adjustment considered as a treatment failure. Results: Symptomatic and partial Mayo remission were sustained through Wk92, with no clinically meaningful differences between the q12w and q8w dose groups (Figures 1 and 2). When dose adjustment was considered to be part of the treatment experience (ie, not a treatment S-1186 AGA Abstracts failure), 66.1 % and 67.0% of pts randomized to q12w and q8w, respectively, were in symptomatic and partial Mayo remission at Wk92 (Figure 1). When dose adjustment was considered to be a treatment failure in the analysis, 53.2% and 54.0% of pts were in symptomatic and partial Mayo remission, respectively (Figure 2). The safety profile of UST through Wk96 was consistent with that previously reported for 1 year. 1,2 Conclusion: The efficacy of UST in pts with moderate-to-severe UC was maintained through 92wks with q12w or q8w SC dosing when dose adjustment was considered to be part of the treatment experience. References: 1. Sands B.E., Sandborn W.J., Panaccione R., et al. N Engl J Med . 2019:381 (13): 1201-1214. 2. Sands B.E., Sandborn W.J., Panaccione R., et al. United European Gastroenterology Week; October 19-23, 2019; Barcelona, Spain. Figure 1: Symptomatic remission a,b,c,d (A) and partial Mayo c,d,e,f (B) over time through Wk 92 for all patients who were randomized in the maintenance study g (dose adjustment was not considered to be a treatment failure) Figure 2: Symptomatic remission a,b,c,d (A) and partial Mayo remission c,d,e,f (B) over time through Wk 92 for all patients who were randomized in the maintenance study g (dose adjustment was considered to be a treatment failure)