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  string(144) "Analysis of Treatment Response and Inclusion in Large-Scale Biologic Therapy Trials Across Age Groups in Inflammatory Bowel Disease (TRIAGE-IBD)"
  ["project_narrative_summary"]=>
  string(650) "This research study aims to explore potential age-related disparities in IBD clinical trial recruitment and retention, baseline disease severity among clinical trial participants, treatment responses, and healthcare utilization. By analyzing data from major clinical trials (UNITI, UNITI-2, IM-UNITI) of a widely used biologic therapy, ustekinumab, the study seeks to explain how age may influence various aspects of trial participation and outcomes. The findings are expected to contribute to the broader understanding of demographic influences in clinical trials, guiding future inflammatory bowel disease research design and treatment approaches. "
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    ["first_name"]=>
    string(5) "Ellen"
    ["last_name"]=>
    string(10) "Zimmermann"
    ["degree"]=>
    string(2) "MD"
    ["primary_affiliation"]=>
    string(45) " University of Florida Department of Medicine"
    ["email"]=>
    string(33) "ellen.zimmermann@medicine.ufl.edu"
    ["state_or_province"]=>
    string(2) "FL"
    ["country"]=>
    string(13) "United States"
  }
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      string(6) "Naueen"
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      string(4) "Pham"
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      string(75) " University of Florida Department of Medicine, Division of Gastroenterology"
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      string(7) "Potlach"
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      string(5) "Aalam"
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      ["p_pers_pr_affil"]=>
      string(50) " University of Florida, Department of Epidemiology"
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      string(2) "Li"
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      string(21) "University of Florida"
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      string(3) "Pei"
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      string(3) "PhD"
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  ["project_ext_grants"]=>
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    ["label"]=>
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  }
  ["project_funding_source"]=>
  string(22) "Local foundation grant"
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1616) "Background

Inflammatory Bowel Disease (IBD) affects around 3 million people in the U.S. [1] and typically presents within the first two to three decades of life [2]. Research shows that adolescents and young adults (AYA) with IBD face distinct challenges in managing their disease and use healthcare services differently from pediatric and older adult patients. They also tend to receive more corticosteroids [3]. However, limited data exist on the role of age in clinical trials for IBD.



Aims

This analysis seeks to identify age-related differences in IBD clinical trial participation, baseline disease severity, treatment response, and dropout rates.



Study Design

Patient-level data for ustekinumab in IBD will be extracted from UNITI-1, UNITI-2, and IM-UNITI trials [4]. Participants are adults (≥18 years) with moderate to severe IBD. Age categories include: 18-25, 26-45, 46-65, and over 65.



Primary Outcome

Comparisons of enrollment, retention, and dropout rates across age groups.



Secondary Outcomes

Evaluations of baseline disease severity, treatment response (clinical and endoscopic remission rates), side effects, and serious adverse events, all stratified by age.



Statistical Analysis

The analysis will use descriptive statistics and inferential tests (Chi-square, logistic regression, ANOVA, and Cox models) to assess enrollment, efficacy, side effects, and time-to-event outcomes across age groups. Complete details of the statistical analysis plan is in the supplementary material. "
  ["project_brief_bg"]=>
  string(2467) "Crohn's Disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD), are chronic inflammatory conditions of the gastrointestinal tract. While ulcerative colitis affects the colon and rectum, Crohn's Disease can affect any part of the alimentary canal. Although IBD pathogenesis is multifaceted, these immune-mediated etiologies are primarily treated with anti-inflammatory drugs, including steroids, immunomodulators, biological agents, and small molecule inhibitors.



25-30% of new diagnoses of Crohn's Disease and ulcerative colitis are made before age 20 [5]. The incidence of IBD is increasing in the U.S. [5]. Adolescents require more immunosuppressive therapy and biologics compared to adults and display significantly different disease distribution [6]. Management is more aggressive in pediatric-onset IBD, with earlier use of immunomodulators and biologics due to severe disease phenotypes and rapid progression [7]. Despite this, clinical trials often enroll older adults and assess drug responses for all adults (over age 18 years) together, leaving unclear associations between age of onset, trial participation, and treatment response.



Data for adults over 65 in IBD trials is also limited. A meta-analysis showed that age was a significant exclusion criterion for 58% of IBD trials [8], despite older adults over age 65 being the fastest-growing population in the U.S. [9]. Unique challenges for older adults with IBD include comorbidity, poly-pharmacy, and age-related decline in innate immunity, which contributes to increased infections [10]. Disease presentation in older adults shows more colonic involvement and less likelihood of stricturing and penetrating disease [10]. Current IBD treatment in adults over 65, involving potent immunosuppressive therapies, is often extrapolated from trial data on middle-aged adults [10].



In 2020, an IBD Partners study showed that underrepresented groups in IBD trials include younger patients, those followed in community settings, and those with milder disease [11]. They also concluded that more studies are needed for populations with prior anti-TNF failure [11]. The present study aims to characterize the role of age in trial participation, retention, and treatment efficacy among IBD patients enrolled in RCTs for induction (UNITI-1, UNITI-2) and maintenance (IM-UNITI) therapy with ustekinumab, an interleukin 12/23 inhibitor [4]."
  ["project_specific_aims"]=>
  string(428) "1. Assess diversity in IBD clinical trial participation and dropout rates across age groups.

2. Examine age-related differences in baseline participant disease severity and comorbidity.

3. Compare induction and maintenance treatment responses for achieving clinical and endoscopic remission stratified by age.

4. Evaluate any variations in trial outcomes based on age and other patient demographics.

"
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(14) "indiv_trial_an"
    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
  array(5) {
    [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(76) "confirm_or_validate previously_conducted_research_on_treatment_effectiveness"
      ["label"]=>
      string(76) "Confirm or validate previously conducted research on treatment effectiveness"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(34) "research_on_clinical_trial_methods"
      ["label"]=>
      string(34) "Research on clinical trial methods"
    }
    [3]=>
    array(2) {
      ["value"]=>
      string(28) "research_on_comparison_group"
      ["label"]=>
      string(28) "Research on comparison group"
    }
    [4]=>
    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(600) "Inclusion Criteria: 

Patients with confirmed inflammatory bowel disease diagnosis that are age 18 years of age or older in induction and maintenance trials assessing Ustekinumab efficacy.

Individuals with moderate to severe IBD activity measured through Crohn's Disease Activity Index (CDAI), endoscopic findings, C-reactive protein (CRP), or other inflammatory marker levels.

Exclusion Criteria: 

Patients treated with other biologic therapies within eight weeks of starting induction therapy  

Individuals previously treated with IL-12/IL-23 antagonists .

"
  ["project_main_outcome_measure"]=>
  string(1403) "a. Clinical Trial Participation Rate:

1. Enrollment per age group divided by total screened.



b. Clinical Trial Dropout Rate:

1. Dropouts per age group at weeks 4, 8, 16, etc.

Metrics: Reasons (adverse events, efficacy, consent), time to dropout, trial stage.



Secondary Outcomes:

a. Baseline Disease Severity:

1. Compare CDAI, C-reactive protein, fecal calprotectin by age at week 0.



b. Treatment Efficacy:

Induction:

1. Response (CDAI ↓100 or under 150) at week 6.

2. Remission (CDAI under 150) at week 8, CDAI ↓70 at weeks 3, 6.

3. CDAI, CRP, fecal calprotectin changes at weeks 3, 6, 8; CRP less than 3.0 mg/L, fecal calprotectin ≤250 or ≤100 mg/kg at week 6.



Maintenance:



1. Remission at week 44.

2. Response , remission, remission maintenance, glucocorticoid-free remission, remission with previous anti-TNF failure at week 44.

3. CDAI, CRP, fecal calprotectin changes through week 44.



c. Side Effects, Safety Profile, and Adverse Events:

1. Track side effects, infections, and adverse events across age groups over time.



d. Pharmacokinetics and Immunogenicity:

1. Ustekinumab drug levels at weeks 0, 3, 6, 8, then every 4 weeks.

2. Antidrug antibody levels at weeks 0, 6, 12, 24, 36, 44."
  ["project_main_predictor_indep"]=>
  string(183) "Age will be the main predictor of this analysis.

1. Young Adults aged 18-25 

2. Adults aged 26-45

3. Adults aged 46-65

4. Older Adults aged over 65

"
  ["project_other_variables_interest"]=>
  string(1122) "We will prioritize age-related factors, including disease duration and time to biologic initiation (both continuous). Disease severity will be categorized by CDAI or as mild, moderate, or severe, and disease location and behavior by the Montreal Classification. Treatment history will distinguish between biologic-naïve and biologic-experienced, with details on anti-TNF failure (e.g., drug count, nonresponse types, side effects). Comorbidity may be evaluated using the Charlson Comorbidity Index. Baseline markers such as CRP, ESR, fecal calprotectin, lactoferrin, hemoglobin, and WBC count, along with nutritional status (BMI, albumin), will be assessed. We will also note IBD medication use and dosages, extra-intestinal manifestations, and biologic dosages. The presence of infections will be recorded. Additionally, gender and race/ethnicity may be used during multivariable adjustment for confounders. If available, we’ll assess quality of life, health economics, endoscopy results, insurance status, income, and geographical location. A specific list of variables by trial is provided in supplementary material."
  ["project_stat_analysis_plan"]=>
  string(1284) "The statistical methods for the analysis plan include a combination of descriptive and inferential techniques. Descriptive statistics will be used to summarize enrollment, retention, dropout rates, treatment efficacy, side effects, and pharmacokinetics across age groups. Chi-square or Fisher’s exact tests will compare proportions, such as enrollment rates, clinical response, remission, adverse events, and the development of antidrug antibodies. Logistic regression models will be employed to assess associations between age groups and binary outcomes, adjusting for covariates such as disease severity and treatment history. For continuous outcomes, such as changes in CDAI, CRP, fecal calprotectin, and Ustekinumab levels, repeated measures ANOVA or mixed-effects models will be used to assess changes over time between age groups. Kaplan-Meier survival analysis and Cox proportional hazards models will evaluate time-to-event outcomes, such as dropout rates and time to first adverse event. These methods provide a comprehensive framework for analyzing both primary and secondary aims across different patient populations. 



Further detail of the statistical analysis plan for each primary and secondary outcome measure is attached in the supplementary material."
  ["project_software_used"]=>
  array(1) {
    [0]=>
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      ["value"]=>
      string(7) "rstudio"
      ["label"]=>
      string(7) "RStudio"
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  ["project_timeline"]=>
  string(192) "October 2024 - January 2025: Data analysis

January - June 2025: Drafting and submission of abstracts.

June 2025 – December 2025: Drafting and submission of manuscripts.

"
  ["project_dissemination_plan"]=>
  string(514) "The results of this analysis will be disseminated as abstracts and poster presentations at target national gastroenterology conferences such as Digestive Disease Week. A subsequent manuscript is anticipated and will be aimed for publication in reputable high-impact journals in the field, such as Gastroenterology, JAMA Gastroenterology, Clinical Gastroenterology and Hepatology, and Inflammatory Bowel Disease Journal. The intended audience for the products of this study includes IBD researchers and clinicians. "
  ["project_bibliography"]=>
  string(3781) "
 

Xu F, Dahlhamer JM, Zammitti EP, Wheaton AG, Croft JB. Health-Risk Behaviors and Chronic Conditions Among Adults with Inflammatory Bowel Disease — United States, 2015 and 2016. MMWR Morb Mortal Wkly Rep. 2019;67(6):190-195. doi:10.15585/MMWR.MM6706A4
Cosnes J, Gowerrousseau C, Seksik P, Cortot A. Epidemiology and Natural History of Inflammatory Bowel Diseases. Gastroenterology. 2011;140(6):1785-1794.e4. doi:10.1053/J.GASTRO.2011.01.055
Hussain FS, Setya A, Molina I, et al. Healthcare Utilization Patterns and Excessive Steroid Use in Late Adolescence Age and Young Adults With Crohn’s Disease and Ulcerative Colitis. Gastro Hep Advances. 2023;2(7):928-934. doi:10.1016/J.GASTHA.2023.06.009
Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease. New England Journal of Medicine. 2016;375(20):1946-1960. doi:10.1056/NEJMOA1602773/SUPPL_FILE/NEJMOA1602773_DISCLOSURES.PDF
Escher JC. Inflammatory bowel disease in children and adolescents: Recommendations for diagnosis – The Porto criteria. J Pediatr Gastroenterol Nutr. 2005;41(1):1-7. doi:10.1097/01.MPG.0000163736.30261.82
Goodhand J, Dawson R, Hefferon M, et al. Inflammatory bowel disease in young people: the case for transitional clinics. Inflamm Bowel Dis. 2010;16(6):947-952. doi:10.1002/IBD.21145
Duricova D, Burisch J, Jess T, Gower-Rousseau C, Lakatos PL. Age-related differences in presentation and course of inflammatory bowel disease: An update on the population-based literature. J Crohns Colitis. 2014;8(11):1351-1361. doi:10.1016/J.CROHNS.2014.05.006/2/8-11-1351-F2.JPEG
Vieujean S, Caron B, Jairath V, et al. Is it time to include older adults in inflammatory bowel disease trials? A call for action. Lancet Healthy Longev. 2022;3(5):e356-e366. doi:10.1016/S2666-7568(22)00060-5/ATTACHMENT/620BD3BE-271E-49BD-8402-1E11E89265C9/MMC1.PDF
Ortman JM, Velkoff VA, Hogan H. An Aging Nation: The Older Population in the United States Population Estimates and Projections Current Population Reports. Published online 2014. Accessed February 20, 2024. www.census.gov/population
Nimmons D, Limdi JK. Elderly patients and inflammatory bowel disease. World J Gastrointest Pharmacol Ther. 2016;7(1):51. doi:10.4292/WJGPT.V7.I1.51
Johnson C, Barnes EL, Zhang X, Long MD. Trends and Characteristics of Clinical Trials Participation for Inflammatory Bowel Disease in the United States: A Report From IBD Partners. Crohns Colitis 360. 2020;2(2). doi:10.1093/CROCOL/OTAA023

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