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  ["project_title"]=>
  string(103) "Comparison of Onset of Efficacy of Therapies for Ulcerative Colitis Based on Patient Symptom Diary Data"
  ["project_narrative_summary"]=>
  string(700) "Ulcerative colitis (UC) is a chronic condition that causes inflammation in the colon and rectum, leading to symptoms such as diarrhea, rectal bleeding, and abdominal pain. These symptoms can significantly impact the quality of life for those affected. It is currently unclear how quickly patients with UC who respond to therapy can expect to have improvement in their symptoms. This study aims to compare the effectiveness of different therapies for UC by looking at how quickly patients experience symptom relief, using data reported by patients in daily symptom diaries. By focusing on patients who respond to treatment, the study provides valuable insights into how soon symptom improvement can be"
  ["project_learn_source"]=>
  string(9) "colleague"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(6) "Neeraj"
    ["last_name"]=>
    string(6) "Narula"
    ["degree"]=>
    string(14) "MD, MPH, FRCPC"
    ["primary_affiliation"]=>
    string(24) "Hamilton Health Sciences"
    ["email"]=>
    string(26) "neeraj.narula@medportal.ca"
    ["state_or_province"]=>
    string(2) "ON"
    ["country"]=>
    string(6) "Canada"
  }
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    [0]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(5) "Emily"
      ["p_pers_l_name"]=>
      string(4) "Wong"
      ["p_pers_degree"]=>
      string(4) "BHSc"
      ["p_pers_pr_affil"]=>
      string(24) "Hamilton Health Sciences"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
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  ["project_ext_grants"]=>
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    ["value"]=>
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    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1657) "Background: Ulcerative colitis (UC) is characterized by inflammation of the colon and rectum. Patients with UC often have diarrhea and rectal bleeding (RB). Disease monitoring with patient-reported outcomes (PROs) are important. A two-item PRO score (PRO-2). which considers stool frequency (SF) and RB, is a validated score that assesses symptom severity (1). These symptoms are often reported by patients using symptom diaries. Clinical trials in UC often present post-hoc analyses comparing daily symptom diaries between drug-treated and placebo-treated patients. These analyses include all patients, regardless of their response to the therapy. Therefore, it is difficult to extrapolate from these analyses how soon responders can expect to experience improvement in their symptoms. 

Objective: To compare the time to onset of symptom improvement, as determined by PRO-2 response (defined as decrease ≥ 50% in RB subscore (RBS) and SF subscore), among patients with UC who are clinical responders at week 8.

Study Design: Post-hoc analysis of clinical trials of patients with moderate-severely active UC.

Participants: Adults with moderate to severely active UC (total Mayo score ≥ 6 with RBS ≥ 1 and endoscopic disease )who received standard induction therapy.

Outcomes: The primary outcome of this study is time to achieve PRO2 response (decrease ≥ 50% in RB subscore (RBS) and SF subscore). Secondary outcomes include PRO2 remission (RBS=0 and SF<=1).

Statistical Analysis: Mean and median time to achieve PRO2 response (primary outcome) will be calculated and compared between therapies.



"
  ["project_brief_bg"]=>
  string(1880) "Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by inflammation and ulceration of the colon and rectum. Patients with UC often experience symptoms such as diarrhea, rectal bleeding (RB) and abdominal pain which can severely impair their quality of life. Given the chronic relapsing and remitting nature of UC, disease monitoring with clinical disease activity indexes based on patient-reported outcomes (PROs) are important. A two-item PRO score (PRO-2). which considers stool frequency (SF) and RB, is a validated score that is frequency used to assess symptom severity among patients with UC (1). These symptoms are often reported by patients using symptom diaries. 



Clinical trials in UC often present post-hoc analyses comparing daily symptom diaries between drug-treated and placebo-treated patients. These analyses include all patients, regardless of their response to the therapy, which may potentially dilute the observed effect. Therefore, it is difficult to extrapolate from these analyses how soon responders can expect to experience improvement in their symptoms. Moreover, it is unclear how therapies for UC compare with regards to the time to onset of symptom relief. 



Impact on Patients:



This study has significant potential benefits for patients with UC. By providing information on the time to symptom relief for different therapies, patients can have more realistic expectations about their treatment outcomes. This can lead to improved treatment adherence and overall patient satisfaction. Additionally, these findings can help physicians tailor treatment plans more effectively, ensuring that patients receive the most appropriate therapy. Ultimately, the study aims to improve the quality of life for UC patients by enabling quicker and more targeted symptom management.

"
  ["project_specific_aims"]=>
  string(805) "This study aims to compare the time to onset of symptom improvement, as determined by PRO-2 response (defined as decrease ≥ 50% in RB subscore (RBS) and SF subscore), among patients with UC who are clinical responders at week 8, defined as ≥ 3 point and ≥ 30% reduction from baseline total Mayo score and a decrease ≥ 1 point in the RBS or absolute RBS ≤ 1.Additional subgroup analyses will be performed based on comorbid psoriasis or psoriatic arthritis (PsO/PsA) to determine whether their presence influences treatment outcomes.

We hypothesize that there are statistically significant differences in PRO-2 response between therapies among clinical responders at week 8. Furthermore, we hypothesize that the presence of comorbid PsO/PsA does not significantly impact treatment efficacy."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(14) "indiv_trial_an"
    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
  array(2) {
    [0]=>
    array(2) {
      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(5) "other"
      ["label"]=>
      string(5) "Other"
    }
  }
  ["project_research_methods"]=>
  string(1192) "This is a post-hoc analysis of clinical trials of patients with moderate-severely active UC (ACT 1, ACT 2, ULTRA 1, ULTRA 2, GEMINI 1, PURSUIT, VARSITY, OCTAVE, LUCENT 1, LUCENT 2 and UNIFI). ACT 1 (NCT00036439) and ACT 2 (NCT00096655) demonstrated infliximab was efficacious to treat moderate to severe UC compared to placebo. Adalimumab and vedolizumab have shown to be effective biologic therapies and have been evaluated for its efficacy and safety in placebo-controlled trials, including ULTRA 1 (NCT00385736) and ULTRA 2 (NCT00408629), and GEMINI 1 (NCT00783718) (2, 3, 4, 5). The VARSITY trial (NCT02497469) was a head-to-head trial that demonstrated vedolizumab was more effective compared to adalimumab, in achieving clinical remission (6). Golimumab has also demonstrated efficacy and safety in the placebo-controlled study PURSUIT (NCT00488631) (7). Ustekinumab was shown to be effective for moderate-severe UC in the UNIFI placebo-controlled trials (NCT02407236) (8). More recently, mirikizumab was approved on the strength of data from the placebo-controlled LUCENT-1 (NCT03518086) and LUCENT-2 (NCT03524092) clinical trials (9). See Supplementary Materials for more information."
  ["project_main_outcome_measure"]=>
  string(789) "The primary outcome of this study is time to achieve PRO2 response, defined as decrease ≥ 50% in RB subscore (RBS) and SF subscore. In the trials, participants were asked to record their symptoms, including presence and severity of rectal bleeding and number of stools on a daily basis. In this study, the PRO2 score will be assessed, which includes the SF subscore and RBS. The SF subscore of the PRO2 score is categorized as 0=normal, 1=1-2 stools more than normal, 2=3-4 stools more than normal and 3=≥5 stools more than normal. The RBS of the PRO2 score is categorized as 0=no blood, 1=streaks of blood seen with stool less than half the time, 2=obvious blood with stool most of the time, and 3=blood alone passed.

See Supplementary Materials for Secondary Outcome Measures."
  ["project_main_predictor_indep"]=>
  string(252) "The main predictor are the types of treatments for UC (infliximab, adalimumab, vedolizumab, golimumab, ustekinumab, mirikizumab and tofacitinib. Additionally, the presence of comorbid psoriasis / psoriatic arthritis will be used for subgroup analyses. "
  ["project_other_variables_interest"]=>
  string(105) "Age (continuous), gender (male/female), prior biologic failure (yes/no), concomitant steroid use (yes/no)"
  ["project_stat_analysis_plan"]=>
  string(1340) "Descriptive statistics will be used to summarize baseline characteristics of the study population. Proportions or percentages will be used to characterize dichotomous variables while continuous variables will be presented as means with standard deviations (SD) or medians with interquartile ranges (IQR). Baseline characteristics will be compared between different treatment groups using appropriate statistical tests (e.g., chi-square test for categorical variables, t-test or Mann-Whitney U test for continuous variables)



For each therapy assessed, the time to achieve PRO2 response (primary outcome) will be presented in mean (SD) and median (IQR) days. Subgroup analyses will be performed based on concomitant steroid use, prior biologic failure and endoscopic disease severity at baseline. Findings will be plotted on graphs to visually compare time to PRO2 response among various therapies. Kaplan-Meier survival curves will be generated to estimate the time to achieve PRO2 response for each therapy. The log-rank test will be used to compare the survival curves between different treatment groups. All analyses will be intention-to-treat (among responders). Stata SE will be used for all statistical analyses. A two-sided p-value of <0.05 will be considered statistically significant for all tests.



"
  ["project_software_used"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(5) "stata"
      ["label"]=>
      string(5) "STATA"
    }
  }
  ["project_timeline"]=>
  string(151) "Start date - September 2024

Completion date - January 2025

Manuscript draft - March 2025

Results reported back to YODA - June 2025"
  ["project_dissemination_plan"]=>
  string(538) "Results of this study will be shared through presentations at IBD conferences and publications in peer-reviewed journals, such as Clinical Gastroenterology and Hepatology and the Journal of American College of Gastroenterology. Further, this information will be of high utility to clinicians attending IBD conferences as they are able to better understand the time it may take their patients to achieve symptomatic relief. This will ultimately inform treatment decision-making and improve the quality of life of patients with UC. 

"
  ["project_bibliography"]=>
  string(2348) "

Jairath V, Khanna R, Zou GY, Stitt L, Mosli M, Vandervoort MK, et al. Development of interim patient-reported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials. Alimentary pharmacology & therapeutics. 2015;42(10):1200-10.
Reinisch W, Sandborn WJ, Hommes DW, D’Haens G, Hanauer S, Schreiber S, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut. 2011;60(6):780-7.
Sandborn WJ, van Assche G, Reinisch W, Colombel JF, D’Haens G, Wolf DC, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142(2):257-65.e1-3.
Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. The New England journal of medicine. 2013;369(8):699-710.
Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. The New England journal of medicine. 2005;353(23):2462-76.
Sands BE, Peyrin-Biroulet L, Loftus EV, Jr., Danese S, Colombel JF, Törüner M, et al. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. The New England journal of medicine. 2019;381(13):1215-26.
Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):96-109.e1.
Sands BE, Sandborn WJ, Panaccione R, O’Brien CD, Zhang H, Johanns J, et al. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. The New England journal of medicine. 2019;381(13):1201-14.
D’Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. New England Journal of Medicine. 2023;388(26):2444-55.
Sandborn WJ, Su C, Sands BE, D’Haens GR, Vermeire S, Schreiber S, et al. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. The New England journal of medicine. 2017;376(18):1723-36.

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