Hi everyone,
We are gearing up to launch our network study. This project began last year as part of the 2025 Bridging Evidence Gaps OHDSI Initiative. Please read more below if interested.
Bridging Evidence Gaps in Infection Risk for Rheumatic Disease Patients
We are launching an OHDSI network study to address a critical evidence gap in rheumatology: the comparative risk of serious infections associated with commonly used immunosuppressive therapies.
Background
Patients with rheumatic and autoimmune diseases (including SLE, systemic sclerosis, inflammatory myositis, and non-infectious uveitis) experience substantial morbidity and mortality. Infectious complications are a major contributor to adverse outcomes, yet comparative safety data across immunosuppressive therapies remain limited.
Study Overview
- Population: Adults (≥18 years) with prevalent rheumatic disease identified using validated OHDSI phenotype algorithms.
- Comparative Aims:
- Aim 1 (Monotherapy): New users of mycophenolate mofetil (MMF), rituximab (RTX), IVIG, or JAK inhibitors (tofacitinib, baricitinib).
- Aim 2 (Combination therapy): Patients on a conventional immunosuppressant (MMF, MTX, or AZA) who initiate a second agent (e.g., RTX, IVIG, JAKi), compared across alternative add-on strategies.
- Outcomes:
- Varicella zoster virus (shingles)
- Hospitalized infection (composite)
- Progressive multifocal leukoencephalopathy (PML)
- Pneumocystis jirovecii pneumonia (PJP)
- Design & Analysis:
New-user and active-comparator designs with time-to-event analyses using large-scale propensity score–adjusted Cox proportional hazards models (OMOP-CDM). Planned negative controls, subgroup analyses (e.g., vaccination and prophylaxis status), and sensitivity analyses will assess robustness and residual confounding.
Participating Sites (to date)
Johns Hopkins, Janssen (Johnson & Johnson), Columbia University, Stanford University, University of Southern California, Penn State University, and UT Southwestern.
The Ask of the OHDSI Community
- Feedback on the protocol (design assumptions, concept sets, analysis plan)
- Feedback on the Strategus code (alignment with protocol intent, efficiency)
- Interest in joining as a data partner
Links
- Study Protocol:
Rheum_Med_Infxn Protocol_1.13.2026 - GitHub Repository (Code & Documentation):
GitHub - OHDSI-JHU/GDE2025RheumInfection: PLE of infection risk from DMARD treatment for rheumatological conditions
Feedback Sessions - please join if able to provide feedback!
- January 26, 10:00 AM ET:
Teams Mtg Link #1 - January 28, 11:00 AM ET:
Teams Mtg Link #2
For questions or interest in participation, please contact cmecoli1@jhmi.edu.