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  ["project_title"]=>
  string(114) "Clinical implications of C-Reactive Protein non-producer status in inflammatory bowel disease: a post hoc analysis"
  ["project_narrative_summary"]=>
  string(679) "Inflammatory bowel disease (IBD), encompassing Crohn’s disease and ulcerative colitis, is frequently monitored using C-reactive protein (CRP) levels, which typically rise with active inflammation. However, 15–25% of individuals with CD are “CRP non-producers” due to genetic variation, showing normal CRP despite objective disease activity. This study will conduct a post-hoc analysis of major clinical trial datasets to determine whether CRP production phenotype influences response to biologic therapy. Findings may enhance understanding of treatment outcomes and inform more precise monitoring strategies for patients whose CRP is an unreliable marker of inflammation."
  ["project_learn_source"]=>
  string(9) "colleague"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(6) "Farhad"
    ["last_name"]=>
    string(7) "Peerani"
    ["degree"]=>
    string(2) "MD"
    ["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"]=>
      string(7) "Crystal"
      ["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"
      ["p_pers_scop_id"]=>
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      ["requires_data_access"]=>
      string(3) "yes"
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    [1]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(6) "Taylor"
      ["p_pers_l_name"]=>
      string(8) "Cromarty"
      ["p_pers_degree"]=>
      string(2) "MS"
      ["p_pers_pr_affil"]=>
      string(21) "University of Alberta"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
    [2]=>
    array(6) {
      ["p_pers_f_name"]=>
      string(5) "Karen"
      ["p_pers_l_name"]=>
      string(7) "Goodman"
      ["p_pers_degree"]=>
      string(3) "PhD"
      ["p_pers_pr_affil"]=>
      string(21) "University of Alberta"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
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  ["project_ext_grants"]=>
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    ["value"]=>
    string(2) "no"
    ["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(1656) "Background

C-reactive protein (CRP) is a key biomarker for monitoring IBD, with elevated CRP correlating with disease activity. However, 15–25% of CD patients are CRP non-producers due to genetic variants, with normal CRP during flares despite inflammation. This limits monitoring accuracy and creates uncertainty about treatment outcomes.

Objective

To evaluate whether CRP production phenotype influences biologic treatment response in CD and ulcerative colitis (UC).

Design, Participants

We will perform a post-hoc analysis. Eligible adults (≥18 years) with moderate-to-severe CD or UC were enrolled in pivotal trials (ACCENT 1, UNITI-1/2, IM-UNITI, GALAXI, ACT 1/2, PURSUIT, UNIFI) with confirmed inflammation, baseline CRP, and documented outcomes.

Outcomes

Participants were assessed for clinical response, remission, and endoscopic healing at week 8 or 30. UNITI-1/2, ACT 1/2, and UNIFI were assessed at week 8; ACCENT 1, ACT 1/2, and PURSUIT were assessed at week 30. Trials will be grouped by their original trial endpoints. Secondary outcomes include fecal calprotectin, quality of life (IBDQ, SF-36), histo-endoscopic healing, and drug levels (if reported).

Statistics

Participants are classified as CRP producers or non-producers. Fisher’s exact test is used to compare the proportion achieving clinical response, remission, or mucosal healing between groups. Secondary outcomes listed above will be compared using t-tests. Univariate analysis will be conducted between baseline variables, and multivariate logistic regression will be used to adjust for potential confounders."
  ["project_brief_bg"]=>
  string(1134) "C-reactive protein (CRP) is a well-established acute-phase reactant and biomarker of systemic inflammation, commonly used in the evaluation and monitoring of inflammatory bowel disease (IBD) (1,2). In patients with Crohn’s disease, elevated CRP levels often correlate with disease activity and therapeutic response, particularly in the context of biologic treatments such as infliximab (3), and lack of CRP response in Crohn’s disease had been associated with lower rates of use of biologic therapy (4). Prior studies have shown that 15-25% of patients with Crohn’s disease do not produce CRP during IBD flares (5,6) due to single nucleotide polymorphisms in CRP-producing genes (6). These individuals, referred to as “CRP non-producers,” present a challenge in clinical assessment and treatment monitoring. Given this biological variation, it remains unclear whether CRP non-producers exhibit comparable therapeutic responses to biologics as patients who do produce CRP during flares. Understanding this difference would have significant implications for disease monitoring strategies and personalized treatment approaches."
  ["project_specific_aims"]=>
  string(570) "The purpose of the study is to use published data from previously-completed clinical trials to determine if there is a difference in CRP-producers and CRP non-producers in terms of their rates of (1) clinical response and remission (2) mucosal healing. This will be achieved by comparing the outcomes of the CRP producer and non-producer groups. The null hypothesis is that there is no difference in biologic response between CRP producers and non-producers since it is associated with a single nucleotide polymorphism and may not affect the actual inflammatory cascade."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
  ["project_purposes"]=>
  array(3) {
    [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(28) "research_on_comparison_group"
      ["label"]=>
      string(28) "Research on comparison group"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(50) "research_on_clinical_prediction_or_risk_prediction"
      ["label"]=>
      string(50) "Research on clinical prediction or risk prediction"
    }
  }
  ["project_research_methods"]=>
  string(714) "This study will utilize data from the Yale University Open Data Access (YODA) Project. Participant-level data will be required for the following trials ACCENT 1 (NCT00207662), UNITI-1 (NCT01369329), UNITI-2 (NCT01369342) for Crohn’s Disease, along with ACT 1 (NCT00036439), ACT 2 (NCT00096655), PURSUIT (NCT00488631), and UNIFI-I (NCT02407236). All studies are placebo-controlled randomized trials that examines the effect of biologics during its induction phase. Randomized participants with baseline C-reactive protein concentration and Crohn’s Disease or ulcerative colitis confirmed by radiography or endoscopy are included in the study. Participants without a baseline CRP will be excluded from the study."
  ["project_main_outcome_measure"]=>
  string(917) "In all trials, participants underwent an assessment for clinical response or remission at either week 8 or week 30. Endoscopic examination to determine mucosal healing is also obtained at that time. The main outcome measured includes clinical response, clinical remission, and mucosal healing at either week 8 or week 30. Specifically, the UNITI-1, UNITI-2, ACT 1, ACT 2, and UNIFI-I trials all have assessment of clinical and endoscopic remission at week 8. ACCENT 1, ACT 1, ACT 2, and PURSUIT  trials all have assessment of clinical and endoscopic remission at week 30. We will be grouping the trials for analysis by when they achieve their primary endpoint at either week 8 or week 30. 



Secondary outcomes we will assess includes fecal calprotectin, quality of life assessment scales (IBDQ) and SF-36 (if provided), histo-endoscopic mucosal healing (if provided),  drug levels (if provided).

"
  ["project_main_predictor_indep"]=>
  string(273) "Participants will be classified as CRP producers (elevated CRP during active disease) or non-producers (normal CRP despite activity). The primary and secondary outcomes will be evaluated against whether a participant is a CRP producer vs a CRP non-producer at week 8 or 30."
  ["project_other_variables_interest"]=>
  string(306) "Secondary outcomes, including rates of clinical response, clinical remission, and quality of life assessments (defined by IBDQ scores) will also be examined. Baseline characteristics including: Age, Sex, Ethnicity, Race, Region of Enrolment will be used to ensure that they are similar between the groups. "
  ["project_stat_analysis_plan"]=>
  string(1787) "Participants will be classified as CRP producers (elevated CRP during active disease) or non-producers (normal CRP despite activity). Baseline data, including patient demographics and disease characteristics, will be summarized using descriptive statistics and compared using t-test or chi square test to determine similarity between the groups. Continuous variables will be reported as means or medians with corresponding standard deviations or interquartile ranges, respectively. 



Fisher’s exact test will be used to compare the proportion of patients who achieve clinical response, clinical remission, or mucosal healing between the two groups. Secondary outcomes, including fecal calprotectin, quality of life assessment scales (IBDQ) and SF-36 (if provided), histo-endoscopic mucosal healing (if provided),  drug levels (if provided), will be compared using t-test to between the two groups. Data from the YODA project will be accessed remotely in a secure environment by designated study investigators. 



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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      string(1) "r"
      ["label"]=>
      string(1) "R"
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    array(2) {
      ["value"]=>
      string(5) "stata"
      ["label"]=>
      string(5) "STATA"
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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

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  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."
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Henriksen M, Jahnsen J, Lygren I, Stray N, Sauar J, Vatn MH, et al. C-reactive protein: a predictive factor and marker of inflammation in inflammatory bowel disease. Results from a prospective population-based study. Gut. 2008 Nov 1;57(11):1518–23.
Vermeire S, Van Assche G, Rutgeerts P. The role of C-reactive protein as an inflammatory marker in gastrointestinal diseases. Nat Clin Pract Gastroenterol Hepatol. 2005 Dec;2(12):580–6.
Jürgens M, Mahachie John JM, Cleynen I, Schnitzler F, Fidder H, van Moerkercke W, et al. Levels of C-reactive Protein Are Associated With Response to Infliximab Therapy in Patients With Crohn’s Disease. Clin Gastroenterol Hepatol. 2011 May 1;9(5):421-427.e1.
Nero JD, Benguzzi M, Pena-Sanchez J, Fowler S. A121 LACK OF CRP RESPONSE IN CROHN’S DISEASE ASSOCIATED WITH LOWER RATES OF BIOLOGIC THERAPY: RESULTS OF A SINGLE CENTER CASE-CONTROL STUDY. J Can Assoc Gastroenterol. 2019 Mar;2(Suppl 2):242–3.
Powles STR, Varey A, Orchard T, Tyrrell-Price J. PTH-095 Are IBD Patients Either CRP Producers or Non-Producers? a Longitudinal Study. Gut. 2013 June 1;62(Suppl 1):A249–50.
Jones J, Loftus EV, Panaccione R, Chen L, Peterson S, Mcconnell J, et al. Relationships Between Disease Activity and Serum and Fecal Biomarkers in Patients With Crohn’s Disease. Clin Gastroenterol Hepatol. 2008 Nov 1;6(11):1218–24.
Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease | New England Journal of Medicine [Internet]. [cited 2025 July 4]. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa1602773
Hanauer SB, Sandborn WJ, Feagan BG, Gasink C, Jacobstein D, Zou B, et al. IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn’s Disease. J Crohns Colitis. 2020 Jan 1;14(1):23–32.
Danese S, Panaccione R, Feagan BG, Afzali A, Rubin DT, Sands BE, et al. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn’s disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial. Lancet Gastroenterol Hepatol. 2024 Feb 1;9(2):133–46.
Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, et al. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sept;42(5):504–14.
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 Sept 26;381(13):1201–14.

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