# Withdrawal of Hydroxychloroquine in Elderly Lupus Patients: Planning Grant

> **NIH NIH R34** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2020 · $226,208

## Abstract

ABSTRACT: Withdrawal of Hydroxychloroquine (HCQ) in Elderly Lupus Patients
This R34 planning grant application is driven by the need to establish evidence-based protocols for the
management of aging lupus patients, a topic that has received minimal attention to date. Thus, clinical
equipoise is needed to better assess elderly patients with stable SLE to more accurately weigh the balance
between accumulating ocular exposure and the explosion of new tools to assess retinal injury versus the risk of
disease flare in a population that may have more inactive disease than younger patients. Despite a track
record of safety with regard to infection compared to traditional immunosuppressive agents, the risk of HCQ
retinal toxicity escalates with continued use. Evaluation using sensitive approaches suggests nearly a third of
patients accrue retinal damage. The decision to discontinue HCQ is difficult but timely, especially in patients
who have been stable and on the medication for years. As the longevity of lupus patients improves, which may
increase comorbidities that affect HCQ clearance (e.g., renal insufficiency), the ratio of efficacy to toxicity
would be expected to decrease. That disease activity may wane in the aging population drives the ratio down
even further. The purpose of this R34 is to provide support for the planning, design and subsequent
implementation of a randomized, controlled multicenter Phase III double-blind non-inferiority trial to address the
safety of withdrawal of HCQ in SLE patients ≥60 years old. The central hypothesis is that HCQ can be safely
discontinued in stable/quiescent patients assessed by validated disease activity and flare instruments and
serologic, cellular, and cytokine profiling. Per the preliminary study design being planned, the primary outcome
is the number of patients in each group who develop a moderate/severe flare during follow-up. Based on the
projection of a 13% flare rate in patients remaining on HCQ and an acceptable rate up to 23% in those who
withdraw (i.e., non-inferiority margin of 10% absolute difference between groups), target enrollment is 165
patients per arm (total 330) followed bi-monthly for 12 months. Eligible patients will have been taking HCQ for
≥7 years, with compliance assessed by HCQ levels. To provide robust evidence generalizable across diverse
ethnic/racial populations and socioeconomic strata, 7 institutions (NYU, HSS, Columbia, Penn State, UCLA,
OMRF, Einstein) comprise the core clinical investigative team. This study will be leveraged to provide insights
into aging of the immune system and its effects on autoimmunity. Trial infrastructure will be established in
compliance with NIH guidelines, and completion of the following deliverables: study protocol with inclusion of
biomarker studies and comprehensive biostatistical analysis plan; manual of operating procedures; electronic
data capture system; data management plan; acquisition of study drugs; training of support staff; submi...

## Key facts

- **NIH application ID:** 9969345
- **Project number:** 5R34AR075283-02
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** Jill P Buyon
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $226,208
- **Award type:** 5
- **Project period:** 2019-07-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969345

## Citation

> US National Institutes of Health, RePORTER application 9969345, Withdrawal of Hydroxychloroquine in Elderly Lupus Patients: Planning Grant (5R34AR075283-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9969345. Licensed CC0.

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