# Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel Diseases

> **NIH NIH K23** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2021 · $189,449

## Abstract

PROJECT SUMMARY/ABSTRACT
The prevalence of inflammatory bowel diseases (IBD) in older adults (≥65y) is rising, and there is limited
evidence-based guidance on treating these older adults. In older patients with multi-morbidity, treatment
decisions should factor in not only risk of disease complications, but also treatment complications and non-IBD,
extra-intestinal complications. Hence, to inform optimal treatment approach, a comprehensive assessment of
comparative effects of different therapies on all of these outcomes is warranted. Existing single-center
observational studies are limited by small sample size, and missing data due to fragmented health care,
whereas administrative claims-based studies are limited by lack of detailed clinical data; these limitations can
be overcome by linking the two data sources. In this patient-oriented mentored career development award
proposal, Dr. Siddharth Singh proposes to: (Aim #1.1) characterize disease burden and treatment patterns,
(Aim #1.2) assess and predict risks of death, disease, treatment and extra-intestinal complications using
machine-learning algorithms and (Aim #2.1) compare overall effectiveness and (Aim #2.2) safety of different
treatment strategies in older patients with IBD. This will be studied using a highly innovative informatics-based
approach in a multi-site, electronic medical record (EMR)-based cohort of older patients with IBD, linked to
their corresponding Medicare claims. The EMR-based cohort will facilitate phenotyping and disease severity
assessment, and linkage to Medicare claims will augment exposure and outcome ascertainment, overcoming
challenges of fragmentation of healthcare and short follow-up. The central hypothesis is that, that older adults
have systematically different risk profiles than younger adults, and using biologic monotherapy is a safer and
more effective approach to treating IBD, as compared to using long-term corticosteroids alone, non-biologic
immunomodulator monotherapy, and combination therapy of biologics and immunomodulators. The access to
the advanced infrastructure of pSCANNER (Patient-centered Scalable National Network for Effectiveness
Research), one of 13 PCORI-funded Clinical Data Research Networks, and entire Medicare database, in a
highly supportive and conducive environment at UCSD, with cross-disciplinary mentorship by a collaborative
and experienced team of mentors and advisors from diverse backgrounds (clinical informatics, comparative
effectiveness research, IBD therapeutics) is a key strength of this application. Besides directly informing clinical
practice on treatment approaches in older patients with IBD, this proposal will enhance the career of the
candidate by providing unique skills in applied clinical informatics, privacy-preserving record linkage
techniques, predictive analytics, and comparative effectiveness research, and create a multi-institutional, EMR-
based cohort of well-characterized IBD patients, linked with Medicare cla...

## Key facts

- **NIH application ID:** 10144995
- **Project number:** 5K23DK117058-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Siddharth Singh
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $189,449
- **Award type:** 5
- **Project period:** 2018-07-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10144995

## Citation

> US National Institutes of Health, RePORTER application 10144995, Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel Diseases (5K23DK117058-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10144995. Licensed CC0.

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