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      string(258) "NCT02407236 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis"
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  ["project_title"]=>
  string(128) "Body mass index and its impact on clinical efficacy of ustekinumab in ulcerative colitis: A Post Hoc Analysis of the UNIFI Trial"
  ["project_narrative_summary"]=>
  string(798) "Ulcerative colitis is a long-term disease that causes inflammation in the colon and can seriously affect quality of life. Ustekinumab is a medication that helps many patients achieve remission, but it is not clear whether body weight affects how well it works. This study will look at patient data from a large clinical trial of ustekinumab to see if treatment results differ depending on body mass index (BMI). Patients will be grouped into categories from underweight to obese, and their response to treatment will be compared. Understanding whether BMI plays a role in treatment success could guide doctors in personalizing therapy and help improve outcomes for patients. This research may also provide insights into how body weight influences response to modern biologic therapies more broadly."
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  array(7) {
    ["first_name"]=>
    string(6) "Farhad"
    ["last_name"]=>
    string(7) "Peerani"
    ["degree"]=>
    string(9) "MD, FRCPC"
    ["primary_affiliation"]=>
    string(21) "University of Alberta"
    ["email"]=>
    string(19) "peerani@ualberta.ca"
    ["state_or_province"]=>
    string(7) "Alberta"
    ["country"]=>
    string(6) "Canada"
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      ["p_pers_f_name"]=>
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      ["p_pers_l_name"]=>
      string(3) "Liu"
      ["p_pers_degree"]=>
      string(2) "MD"
      ["p_pers_pr_affil"]=>
      string(50) "University of Alberta Division of Gastroenterology"
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      ["requires_data_access"]=>
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  ["project_ext_grants"]=>
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    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
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  ["property_scientific_abstract"]=>
  string(1709) "Background:

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colon. Ustekinumab, an IL-12/23 antagonist, has proven effective for induction and maintenance therapy in moderate-to-severe UC. While obesity is associated with poor outcomes in IBD, its effect on ustekinumab efficacy in UC is unknown.



Objective:

To evaluate whether body mass index (BMI) influences the clinical efficacy of ustekinumab in moderate-to-severe UC.



Study Design:

This is a post hoc analysis of the phase 3 UNIFI trial.



Participants:

Patients will be stratified by baseline BMI into underweight (<18.5 kg/m²), normal (18.5–25 kg/m²), overweight (25–1). Secondary outcomes include endoscopic response, clinical response, IBDQ score change, histo-endoscopic mucosal healing, corticosteroid-free remission (week 44), ustekinumab drug levels, CRP, and fecal calprotectin.



1'/2' Outcome

Primary endpoint will be the rate of clinical remission at week  8 and 44. Secondary endpoints include endoscopic response, clinical response, and change from baseline in the IBDQ score, and histo-endoscopic mucosal healing. At week 44, we will assess for steroid-free remission, ustekinumab drug levels.



Statistics

Categorical outcomes will be compared across BMI groups using chi-square tests; continuous variables by ANOVA. Univariate analyses will assess associations between baseline characteristics and treatment response. Multivariate logistic regression will adjust for confounders including demographics, disease features, prior therapies, and biomarkers."
  ["project_brief_bg"]=>
  string(1046) "Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing and remitting inflammation of the colon. Ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, has been shown to be effective in inducing and maintaining remission in patients with moderate-to-severe UC, with an 8-week intravenous induction therapy followed by subcutaneous maintenance injection regimen. (1,2) There are studies showing obesity independently associated with poor prognosis in inflammatory bowel disease. (3) Although BMI was shown to not affect the clinical efficacy in Crohn’s disease (4), the impact of Body Mass Index (BMI) on the clinical efficacy of ustekinumab in ulcerative colitis patients remains unclear. This study will provide valuable insights into the role of BMI in the treatment response to ustekinumab in UC, potentially guiding personalized treatment strategies. (5) Understanding the influence of BMI on the efficacy of ustekinumab could help optimize treatment outcomes for UC patients."
  ["project_specific_aims"]=>
  string(737) "The purpose of the study is to use published data that examined Ustekinumab use in ulcerative colitis to determine if there is a difference in efficacy for obtaining (1) clinical remission and (2) mucosal healing patients with different BMIs.  The hypothesis is that there is no significant difference in the clinical efficacy of Ustekinumab based on BMI, given that prior studies that examined Ustekinumab efficacy in Crohn’s Disease had not found significant difference. However, to date, this has yet to be examined in the context of ulcerative colitis. This study would help to direct clinical practice to determine if a patient’s BMI would influence the dosage and interval of Ustekinumab in the treatment of ulcerative colitis."
  ["project_study_design"]=>
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    ["label"]=>
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  ["project_purposes"]=>
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      ["label"]=>
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    [1]=>
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      ["label"]=>
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  ["project_research_methods"]=>
  string(677) "This study will utilize data from the Yale University Open Data Access (YODA) Project. Participant-level data will be required from the UNIFI trial (NCT02407236). 



All patients enrolled in the UNIFI trial will be included in the study. Patients without a baseline BMI will be excluded from the study. Therefore, the inclusion criteria is similar to the original UNIFI study: Participants will have a clinical diagnosis of ulcerative colitis that is moderately-to-severe in activity (defined by baseline Mayo score of 6-12), and have been off of vedolizimab and anti-TNF (for at least 4 months and 8 weeks, respectively).  



Exclusion criteria: None"
  ["project_main_outcome_measure"]=>
  string(532) "The primary endpoint will be the rate of clinical remission at week  8 and week 44. Clinical remission will be defined as a total Mayo score of ≤2 with no subscore >1 on any of the four components.  Secondary endpoints will include endoscopic response (Mayo endoscopic subscore of 0 or 1), clinical response, and change from baseline in the IBDQ score, and histo-endoscopic mucosal healing. At week 44, we will additionally assess for corticosteroid-free clinical remission, ustekinumab drug level, CRP, and fecal calprotectin."
  ["project_main_predictor_indep"]=>
  string(308) "The main independent variable is the body mass index (BMI) of the participants. Patients enrolled in the UNIFI trial will be stratified into BMI categories (underweight <18.5 kg/m2, normal 18.5 to 25 kg/m2, overweight 25 to <30 kg/m2, and obese ≥30 kg/m2) based on their baseline BMI at study entry. "
  ["project_other_variables_interest"]=>
  string(648) "Univariate analyses will be conducted between baseline variables and the outcomes of interest. Baseline characteristics would include age, sex, race, region, smoking status, disease duration, disease location, presence of extraintestinal manifestations, baseline steroid use, baseline immunomodulator use, intolerance or contraindication to immunomodulators, previous immunomodulator use or failure, previous steroid use or failure, previous TNF antagonist therapy, previous vedolizumab therapy, baseline C-reactive protein (CRP) <3 mg/L, baseline fecal calprotectin (FC) <250 mg/kg, induction dose received, and maintenance dose allocation. "
  ["project_stat_analysis_plan"]=>
  string(1092) "Continuous variables will be presented as means (and standard deviations) or medians (and interquartile ranges). The rates of clinical remission and other endpoints will be compared across BMI categories using chi-square tests for categorical variables and ANOVA for continuous variables. A P value of < 0.05 was considered significant.

Univariate analyses will be conducted between baseline variables and the outcomes of interest. Baseline characteristics would include age, sex, race, region, smoking status, disease duration, disease location, presence of extraintestinal manifestations, baseline steroid use, baseline immunomodulator use, intolerance or contraindication to immunomodulators, previous immunomodulator use or failure, previous steroid use or failure, previous TNF antagonist therapy, previous vedolizumab therapy, baseline C-reactive protein (CRP) <3 mg/L, baseline fecal calprotectin (FC) <250 mg/kg, induction dose received, and maintenance dose allocation. Multivariate logistic regression will be used to adjust for potential confounders, listed above. "
  ["project_software_used"]=>
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    [0]=>
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      ["value"]=>
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      ["label"]=>
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    [1]=>
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      ["value"]=>
      string(5) "stata"
      ["label"]=>
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  ["project_timeline"]=>
  string(258) "Date to Start Project: September/October 2025

Date to Complete Analysis: November/December 2025

Date to Draft Manuscript: February/March 2026

Date to Submit Manuscript: April/May 2026

Report back to YODA project: June 2026

"
  ["project_dissemination_plan"]=>
  string(378) "The study results may be shared through posters, abstracts, and presentations at conferences such as Canadian Digestive Diseases Week, Digestive Disease Week, and the European Crohn’s and Colitis Organisation. A manuscript may also be submitted to a peer-reviewed journal. All study outputs will acknowledge the YODA Project data and share these acknowledgments at submission."
  ["project_bibliography"]=>
  string(1697) "
References

Sands BE, Sandborn WJ, Panaccione R, O’Brien CD, Zhang H, Johanns J, et al. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201–14.
Feuerstein JD, Isaacs KL, Schneider Y, Siddique SM, Falck-Ytter Y, Singh S, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020 Apr 1;158(5):1450–61.
Harper JW, Sinanan MN, Zisman TL. Increased body mass index is associated with earlier time to loss of response to infliximab in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2013 Sep;19(10):2118–24.
Wong ECL, Marshall JK, Reinisch W, Narula N. Body Mass Index Does Not Impact Clinical Efficacy of Ustekinumab in Crohn’s Disease: A Post Hoc Analysis of the IM-UNITI Trial. Inflamm Bowel Dis. 2021 Jun 1;27(6):848–54.
Singh S, Proudfoot J, Xu R, Sandborn WJ. Obesity and Response to Infliximab in Patients with Inflammatory Bowel Diseases: Pooled Analysis of Individual Participant Data from Clinical Trials. Off J Am Coll Gastroenterol ACG. 2018 Jun;113(6):883.
D’Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, et al. A Review of Activity Indices and Efficacy End Points for Clinical Trials of Medical Therapy in Adults With Ulcerative Colitis. Gastroenterology. 2007 Feb 1;132(2):763–86.
Irvine EJ, Feagan B, Rochon J, Archambault A, Fedorak RN, Groll A, et al. Quality of life: A valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Gastroenterology. 1994 Feb;106(2):287–96.

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