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      string(251) "NCT03464136 - A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease"
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  string(103) "Comparative Safety and Effectiveness of Ustekinumab and Adalimumab in Older Adults with Crohn's Disease"
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  string(636) "Crohn’s disease (CD) is a type of inflammatory bowel disease (IBD) that causes inflammation to the digestive tract. Biologics are a relatively newer group of medications for treating CD. While biologics have improved medical management of CD, little is known about which biologics are safest and most effective in the older adult population, which comprises the fastest growing demographic of people with IBD. This study will leverage data from the first head-to-head randomized control trial of biologic agents for the treatment of CD to evaluate the efficacy and safety of two biologics, ustekinumab vs. adalimumab, in the elderly. "
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    string(45) "NYU Langone Inflammatory Bowel Disease Center"
    ["email"]=>
    string(24) "adam.faye@nyulangone.org"
    ["state_or_province"]=>
    string(8) "New York"
    ["country"]=>
    string(24) "United States of America"
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1406) "-Background: The growing population of older adults with Crohn’s disease (CD) faces challenges in treatment with biologics. Not much is known about the comparative safety and efficacy of various biologic therapies in the older CD population.

-Objective: Compare ustekinumab vs. adalimumab in efficacy and safety in older adults with Crohn’s Disease. 

-Study Design: A post-hoc analysis comparing clinical efficacy and safety measures in older adults receiving ustekinumab versus older adults receiving adalimumab. 

-Participants: Adults ≥50 with moderate-to-severe Crohn’s disease who received either ustekinumab or adalimumab monotherapy 

-Outcomes: The primary outcome will be clinical remission, defined as CDAI <150. The secondary outcomes will compare endoscopic response, time to clinical response, and safety events of interest including infections, serious infections, and serious adverse events (SAE).

-Analysis: comparison of variables will be performed by T-tests, Mann-Whitney tests, Chi-square tests, or Fisher Exact tests, as appropriate. Survival analysis will be performed to assess time to clinical response. Multivariable logistic regression models adjusting for potential confounders will be used to examine the effect of biologic type on clinical efficacy and safety outcomes in the management of Crohn’s Disease in older adults. 

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  ["project_brief_bg"]=>
  string(2813) "The number of people living with inflammatory bowel disease (IBD) over the age of 60 years old is projected to double by 2030 as compared to 2008, making older adults the fastest growing demographic of patients with IBD.1,2 

Treating older adults with IBD presents unique clinical challenges. These patients often face increased disease-related morbidity and mortality. For example, one study showed that older adults with IBD-related hospitalizations had an increased risk of mortality compared to their younger counterparts.3 Older adults with IBD also tend to have more comorbidities and associated polypharmacy, which is associated with adverse effects. For example, among older adults with IBD, polypharmacy has been associated with disease flares, treatment nonadherence, and increased hospitalization rates.4,5 This clinical complexity of treating older adults with IBD is further complicated by our limited understanding of how advanced IBD treatments, such as biologics, perform in this population. 

In the last 20 years, biologics agents have become the mainstay of treatment for moderate-to-severe IBD.6 Yet, there is more reluctance to treat older adults with these advanced therapies. One reason being that biologics have been linked to increased risks of infection and malignancy, which may be heightened in older adults given the aging-related decline in immune function and damage repair mechanisms.7 Additionally, age related comorbidities often preclude older adults from clinical trials. Thus, data on the comparative safety and efficacy profiles of biologic therapies in older adults is limited. There have been some studies comparing anti-tumor necrosis factor (anti-TNF) to vedolizumab, a selective monoclonal antibody that inhibits integrins, in older adults with IBD. Of these studies, Kochar et al found that vedolizumab was safer than anti-TNF while Adar et al found no significant differences in safety or efficacy between the two therapies when used in older adults with IBD.6,8 Ustekinumab, a biologic agent that inhibits inflammatory cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), is even less studied in comparative trials. A prospective, observational study found similar safety of anti-TNF agents when compared with vedolizumab or ustekinumab in older adults with IBD, however the later two agents were grouped together for the analysis.9 A recent study looked at only ustekinumab as it compares in safety and efficacy to anti-tnf agents in older adults with Crohn’s disease, however this was a retrospective study, thus making it more susceptible to bias.7 To our knowledge, no prospective studies comparing ustekinumab and anti-tnf agents in older adults with Crohn’s disease exist. We have set out to address this gap in the literature. 

"
  ["project_specific_aims"]=>
  string(526) "- We aim to compare the safety and efficacy of ustekinumab to adalimumab (anti-TNF agent) in the treatment of older adults (aged ≥50 years) with Crohn's disease using data from a prospective randomized controlled trial. 

- We hypothesize that in adults aged ≥50 years with inflammatory bowel disease, ustekinumab treatment will demonstrate a superior safety profile with comparable efficacy compared to adalimumab, consistent with findings from the parent trial (SEAVUE) in the general IBD adult population.

"
  ["project_study_design"]=>
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  ["project_research_methods"]=>
  string(332) "-Data source: SEAVUE (NCT03464136)

-Inclusion Criteria: Participants from the included trial who met eligibility criteria for the trial and were ≥ 50 years old

-Exclusion Criteria: Anyone <50 years old and/or anyone who was switched to a different therapy at any point throughout the study period.



"
  ["project_main_outcome_measure"]=>
  string(1262) "The primary outcome measure is clinical remission, defined as Crohn's Disease Activity Index (CDAI) score <150 points at week 52. Both absolute differences (raw difference in clinical remission rates) and relative differences (ratio of remission rates) between adalimumab and ustekinumab groups will be assessed.



Secondary remission-related outcomes include:

-Corticosteroid-free remission at Week 52: CDAI <150 and no corticosteroids for ≥30 days prior

-Clinical response at Week 52: CDAI reduction ≥100 points from baseline

-Time to clinical response: Assessed at Weeks 2, 8, 16, 24, 32, 40, 48, and 52

-Patient reported outcome (PRO)-2 symptom remission at Week 52: Abdominal pain mean daily score ≤1 and stool frequency mean daily score ≤3

-Clinical remission at Week 16: CDAI <150

-Endoscopic remission at Week 52: Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤3, or SES-CD=0 for participants who entered with SES-CD=3



Secondary safety-related outcomes will be assessed at Weeks 52 and 76, including:

-Infections

-Serious infections

-Serious adverse events (SAEs) (death, hospitalization, disability, life-threatening event)

"
  ["project_main_predictor_indep"]=>
  string(200) "The main predictor/independent variable is biologic type 

-Group 1 will be defined as the ustekinumab treatment group 

-Group 2 will be defined as the adalimumab treatment group 

"
  ["project_other_variables_interest"]=>
  string(180) "Additional variables of interest will include absolute and relative differences in antibody formation, which will be defined as those with positive anti-drug assays up to Week 52. "
  ["project_stat_analysis_plan"]=>
  string(645) "Continuous variables will be compared using either t-tests of Mann-Whitney tests. Categorical variables will be compared using Chi square tests or Fisher Exact tests. A survival analysis will be performed to compare time to treatment response between the two treatment groups. A sensitivity analysis for those >= 60 years old will be performed for all variables. Depending on the sample size, we will try to perform multivariable logistic regression models adjusting for potential confounders to examine the effect of biologic type on clinical efficacy and safety of biologic therapies in the management of Crohn’s Disease in older adults. "
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  string(254) "-Anticipated Start Date: March 10, 2025

-Analysis Completion Date: April 15, 2025

-Report of Results to YODA: July 1, 2025

-Date of First Manuscript Draft: February 1, 2026

-Date of Manuscript Submission: April 1, 2026

"
  ["project_dissemination_plan"]=>
  string(277) "The intended audience for this work includes general gastroenterologists and IBD sub-specialists. We believe this work would be relevant for potential publication in the American Journal in Gastroenterology, Inflammatory Bowel Disease, or the Journal of Crohn’s and Colitis. "
  ["project_bibliography"]=>
  string(2290) "

Coward S, Clement F, Benchimol EI, et al. Past and Future Burden of Inflammatory Bowel Diseases Based on Modeling of Population-Based Data. Gastroenterology. Apr 2019;156(5):1345-1353 e4. doi:10.1053/j.gastro.2019.01.002
Nguyen GC, Targownik LE, Singh H, et al. The Impact of Inflammatory Bowel Disease in Canada 2018: IBD in Seniors. J Can Assoc Gastroenterol. Feb 2019;2(Suppl 1):S68-S72. doi:10.1093/jcag/gwy051
Ananthakrishnan AN, McGinley EL, Binion DG. Inflammatory bowel disease in the elderly is associated with worse outcomes: a national study of hospitalizations. Inflamm Bowel Dis. Feb 2009;15(2):182-9. doi:10.1002/ibd.20628
Wang J, Nakamura TI, Tuskey AG, Behm BW. Polypharmacy is a risk factor for disease flare in adult patients with ulcerative colitis: a retrospective cohort study. Intest Res. Oct 2019;17(4):496-503. doi:10.5217/ir.2019.00050
Mesonero F, Fernandez C, Sanchez-Rodriguez E, et al. Polypharmacy in Patients With Inflammatory Bowel Disease: Prevalence and Outcomes in a Single-center Series. J Clin Gastroenterol. Mar 1 2022;56(3):e189-e195. doi:10.1097/MCG.0000000000001647
Kochar B, Pate V, Kappelman MD, et al. Vedolizumab Is Associated With a Lower Risk of Serious Infections Than Anti-Tumor Necrosis Factor Agents in Older Adults. Clin Gastroenterol Hepatol. Jun 2022;20(6):1299-1305 e5. doi:10.1016/j.cgh.2021.08.047
Gebeyehu GG, Broglio G, Liu E, et al. Comparative Safety and Effectiveness of Ustekinumab and Anti-TNF in Elderly Crohn’s Disease Patients. Inflamm Bowel Dis. Aug 3 2024;doi:10.1093/ibd/izae174
Adar T, Faleck D, Sasidharan S, et al. Comparative safety and effectiveness of tumor necrosis factor alpha antagonists and vedolizumab in elderly IBD patients: a multicentre study. Aliment Pharmacol Ther. Apr 2019;49(7):873-879. doi:10.1111/apt.15177
Bozon A, Nancey S, Serrero M, et al. Risk of infection in elderly patients with inflammatory bowel disease under biologics: A prospective, multicenter, observational, one-year follow-up comparative study. Clin Res Hepatol Gastroenterol. May 2023;47(5):102107. doi:10.1016/j.clinre.2023.102107

 
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