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Investigating clinical heterogeneity in immune checkpoint inhibitor-induced inflammatory arthritis

Award Number: R01AR085636
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/02/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2031

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Investigating clinical heterogeneity in immune checkpoint inhibitor-induced inflammatory arthritis - Project Summary/Abstract The proposal aims to address key knowledge gaps about heterogeneity in trajectories, treatment response, targeted tissues, and immune responses for immune checkpoint inhibitor-induced inflammatory arthritis (ICI- IA). ICIs are an increasingly important immunotherapy treatment for a variety of cancers and can cause immune related adverse events (irAEs) due to excess inflammation in non-tumor tissues. ICI-IA is negatively impactful for patients, causes permanent joint damage, and can persist for months to years after ICI cessation in a subset of patients. Additionally, treatment with immunosuppression presents concerns about a negative impact on tumor response. ICI-IA has key differences from traditional forms of IA like rheumatoid arthritis and spondyloarthritis; patients are unlikely to be seropositive for rheumatoid factor or anti-CCP antibodies, lack a predominance of HLA B27, and can have inflammation not just in synovium and tendons but also in surrounding muscle and fascia. The proposed projects will utilize the first prospective USA multicenter cohort of rheumatic irAEs, the Rheumatology Adverse events Due to Immunotherapy Observational Study (RADIOS) cohort, to study ICI-IA. RADIOS has 12 academic sites around the country. First, we will determine how baseline clinical features, ICI-IA disease activity, and steroid dosing in the first six months affect allocation of steroid sparing immunosuppression. This information will be used to account for heterogeneity in treatment allocation so that efficacy of steroid sparing immunosuppression on ICI-IA disease activity and ICI-IA persistence can both be evaluated. Second, a prospective musculoskeletal ultrasound study will be performed. The ultrasound study will focus both on join and muscle structures. This study will determine patterns of tissue involvement and their prevalence in ICI-IA and allow for the evaluation of how differing tissue involvement at baseline relates to future clinical outcomes. Third, peripheral blood cytokine levels will be evaluated as potential biomarkers for disease severity. Finally, predictive models incorporating both cytokine data and baseline clinical features will be developed for clinical outcomes in ICI-IA. The results of the proposed studies will inform the design of rational clinical trials for the treatment of ICI-IA and the development of tools for assessing risk for severe outcomes, helping to guide therapeutic decisions.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $569,402 )
2026	2026	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	7/6/2026	NEW	$569,402
														Subtotal = $569,402

Grand Total All Awards = $569,402

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Investigating clinical heterogeneity in immune checkpoint inhibitor-induced inflammatory arthritis

Award Number: R01AR085636

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/02/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2031

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