# Effects of biologic and targeted therapies  for rheumatoid arthritis on cancer outcomes

> **NIH NIH R01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2022 · $246,985

## Abstract

PROJECT SUMMARY
The treatment of rheumatoid arthritis (RA) has changed substantially in the last two decades with the
development of new biologic and targeted therapies which modulate the immune system. It is well accepted that
these agents do not increase risk of developing new cancers, however, their safety in patients with RA who
have concomitant cancer is controversial given their immunomodulatory potential which could increase the risk
of cancer progression or recurrence, and result in the development of other adverse events such as infections.
Decision making in complex situations, as is the case for patients with RA and cancer who need treatment for
their arthritis, can be challenging in the face of uncertainty. The potential effects of biologic and targeted RA
therapies on cancer progression and survival in patients with cancer are largely unknown, precluding
development of risk models and tools that can aid in these complex decisions. We are proposing this study to fill
current gaps in knowledge in several areas. First, we will perform secondary data analyses of the Surveillance,
Epidemiology and End Results (SEER), Texas Cancer Registry (TCR) Medicare linked files, Optum Clinformatics
Data Mart, and The University of Texas MD Anderson Cancer Center electronic health records. We will examine
the association of use of biologic and targeted therapies in patients with RA and concomitant cancer, with survival
across various cancer types. Second, using the same datasets, we will evaluate other safety outcomes including
serious infections, unplanned hospitalizations and new primary malignancies. Third, in order to understand the
informational needs of patients with RA and concomitant cancer, we will conduct cognitive interviews of patients
with both diseases to assess their beliefs with respect to the potential harms and benefits of biologic and targeted
therapies for RA, and their preferences. Lastly, we will conduct interviews with rheumatologists and oncologists
to ascertain their beliefs and decision-making data needs for choosing RA therapies in patients with concomitant
cancer. Our ultimate goal is to use the information gained with this study to develop a risk prediction model and
decision tool that can assist patients with RA and cancer, and their physicians, in making informed choices about
RA treatment. Results of this study will have a great impact as approximately 1.5 million people in the United
States have RA, and one in three men and one in two women will develop cancer over their lifetime, facing
complex therapeutic decisions about their treatments. Investigators in this proposal have an excellent track
record of successful observational studies and our preliminary data demonstrates the feasibility of the proposed
study objectives. The knowledge gained from this clinical observational study will lay the groundwork needed to
design a future clinical study evaluating a treatment decision-making aid.

## Key facts

- **NIH application ID:** 10456286
- **Project number:** 5R01AR078484-02
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** SHARON Hermes GIORDANO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $246,985
- **Award type:** 5
- **Project period:** 2021-07-23 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10456286

## Citation

> US National Institutes of Health, RePORTER application 10456286, Effects of biologic and targeted therapies  for rheumatoid arthritis on cancer outcomes (5R01AR078484-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10456286. Licensed CC0.

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