Immune Checkpoint Inhibitor-Induced Inflammatory Arthritis
Conditions
Keywords
Checkpoint Arthritis
Brief summary
Immune checkpoint inhibitors (ICI) can cause immune related adverse events like inflammatory arthritis (ICI-IA). ICI-IA is a new and impactful condition, but there is limited understanding of pathogenesis, natural history, and response to treatments. The study will have two main goals. 1. Evaluate efficacy of steroid sparing immunosuppression and determinants of ICI-IA persistence. 2. Identify biomarkers that predict ICI-IA disease severity and initial treatment-associated response. These questions will be answered using the RADIOS cohort, a prospective cohort of patients with rheumatic immune related adverse events due to ICI therapy.
Detailed description
Immune checkpoint inhibitors (ICI) were first approved in the US in 2011, and ICI-induced inflammatory arthritis (ICI-IA) was first described in the literature in isolated case reports and then in the investigator's case series in 2015-2016. ICI-IA has been recognized as a disease entity for only 10 years, thus there are fundamental features of the disease which are yet to be defined. These include understanding the clinical heterogeneity of ICI-IA, factors influencing treatment selection and response to treatment, and prognostic biomarkers for ICI-IA persistence, all of which will be addressed in the proposed studies. The RADIOS consortium, a multicenter consortium already approved as a research resource at Johns Hopkins, will provide all clinical data for this study. Investigators at outside sites that are part of the RADIOS consortium are collaborating to add their expertise in statistical analysis and to have an adequate number of samples for the biomarker work.
Interventions
None listed
Sponsors
Johns Hopkins University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients enrolled in RADIOS (IRB00263113) with immune checkpoint inhibitor-induced inflammatory arthritis will be included.
Exclusion criteria
* Preexisting systemic autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity as assessed by the Clinical Disease Activity Index (CDAI) | baseline, at 2-4 month follow up visit, at 3 months and 6 months post ICI cessation | Add four numbers to get a total score from 0 to 76. 1)Tender Joint Count (0-28): How many of 28 specific joints hurt when touched. 2)Swollen Joint Count (0-28): How many of 28 specific joints are swollen. 3)Patient Global Assessment (0-10): How the patient feels their overall health is doing. 4)Provider Global Assessment (0-10): How the doctor feels the patient's disease is doing. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura Cappelli, MD
Johns Hopkins Division of Rheumatology
Outcome results
None listed