What side effects are associated with this type of intervention?

Hydroxychloroquine, a common treatment for systemic lupus erythematosus (SLE), is effective in reducing disease activity but carries a risk of retinal toxicity, especially with prolonged use. Other side effects include gastrointestinal disturbances, skin eruptions, and potential hematologic and neurologic effects. Regular monitoring, particularly of ocular health, is recommended to mitigate these risks.

What prior FDA approvals exist?

Hydroxychloroquine (HCQ) is an FDA-approved medication commonly used to manage systemic lupus erythematosus (SLE) due to its effectiveness in reducing disease activity and preventing flares. Despite its benefits, long-term use of HCQ carries a risk of retinal toxicity, prompting studies on the safety of discontinuing the drug in stable patients. Other FDA-approved treatments for lupus include corticosteroids, immunosuppressive agents like methotrexate, and biologics such as belimumab. These treatments aim to control inflammation and modulate the immune system, similar to the immunomodulating properties of hydroxychloroquine.

What other types of research exist?

Promising alternatives to hydroxychloroquine for stable SLE patients considering discontinuation include methotrexate, which has shown efficacy in other autoimmune conditions and can be used in combination with HCQ. Additionally, biologic agents such as belimumab, which targets B-lymphocyte stimulator (BLyS), and rituximab, which targets CD20 on B cells, are potential options. These alternatives can help manage disease activity while minimizing the risk of flares. It is essential to consult with a healthcare provider to tailor the treatment plan to individual patient needs.

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Anti-malarial drug

Stopping Hydroxychloroquine for Lupus (SHIELD Trial)

Phase 3

Recruiting

Led By Peter Izmirly

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

Pivotal Trial

Summary

This trial is testing if older lupus patients can safely stop taking Hydroxychloroquine, a drug that reduces lupus symptoms but can harm the eyes over time. The study focuses on patients aged 60 and above who have stable disease. Researchers will monitor these patients for an extended period to see if their condition remains stable without the drug.

Who is the study for?

This trial is for stable/quiescent elderly patients (60+ years) with systemic lupus erythematosus who've been on Hydroxychloroquine (≥200mg daily) for at least 7 years. They must have no recent severe flares, be able to take oral meds, and show no retinal damage. Those on high-dose steroids or immunosuppressants are excluded.

What is being tested?

The study tests the safety of stopping Hydroxychloroquine in older adults with inactive lupus by comparing it against a placebo. Participants will be randomly assigned to either continue HCQ or switch to a placebo and monitored bi-monthly for a year to track disease activity.

What are the potential side effects?

While not explicitly stated, potential side effects may include increased risk of lupus flare-ups after stopping Hydroxychloroquine. Regular medication can cause eye issues over time but this trial focuses on safely discontinuing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI)

Secondary study objectives

Change in 29-Question Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score

Change in 36-Item Short Form Survey Instrument (SF-36) Score

Number of Participants who Develop Moderate Flare based on rSFI

+2 more

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250

13%

Upper respiratory tract infection

Neutropenia

Sinusitis

Alanine aminotransferase increased

Urinary tract infection

Injection site erythema

Accidental overdose

Bronchitis

Injection site pruritus

Thrombocytopenia

Nasopharyngitis

Contusion

Arthralgia

Wolff-Parkinson-White syndrome

Coronary artery occlusion

Anaemia

Leukopenia

Lumbar spinal stenosis

Transient ischaemic attack

Vertebrobasilar insufficiency

Chronic obstructive pulmonary disease

Small intestinal obstruction

Nephrolithiasis

Cataract

Thrombophlebitis superficial

Vomiting

Endometrial hyperplasia

Traumatic arthritis

Hypertension

Pneumonia

Pancreatic carcinoma metastatic

Osteoarthritis

Rheumatoid lung

Pharyngitis

Femoral neck fracture

100%

80%

60%

40%

20%

Study treatment Arm

Sarilumab 150 mg by PFS (Extension Phase)

Sarilumab 150 mg by AID (AID Assessment Phase)

Sarilumab 150 mg by PFS (AID Assessment Phase)

Sarilumab 200 mg by PFS (AID Assessment Phase)

Sarilumab 200 mg by AID (AID Assessment Phase)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Hydroxychloroquine (HCQ)Experimental Treatment1 Intervention

Patients will receive a 90-day supply of HCQ at their screening visit, at 2 months, 4 months, 6 months, 8 months, and 10 months. All patients will return their current supply along with a completed dosing diary at each visit and receive a new supply in exchange. The HCQ dose administered will match each patient's dosage of HCQ at enrollment.

Group II: HCQ-Matching PlaceboPlacebo Group1 Intervention

Patients will receive a 90-day supply of HCQ-matching placebo at their screening visit, at 2 months, 4 months, 6 months, 8 months, and 10 months. All patients will return their current supply along with a completed dosing diary at each visit and receive a new supply in exchange. The HCQ-matching placebo dose administered will match each patient's dosage of HCQ at enrollment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydroxychloroquine

2017

Completed Phase 4

~3990

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hydroxychloroquine, a cornerstone treatment for systemic lupus erythematosus (SLE), works by modulating the immune system. It inhibits toll-like receptors (TLRs) on plasmacytoid dendritic cells, reducing the activation of these cells and subsequent production of interferon, a key driver of inflammation in Lupus. This mechanism helps decrease disease activity and prevent flares. Other common treatments include corticosteroids, which reduce inflammation by suppressing the immune response, and immunosuppressants like methotrexate, which inhibit the proliferation of immune cells. Understanding these mechanisms is crucial for Lupus patients as it highlights the importance of these medications in controlling the disease and preventing organ damage. In the context of hydroxychloroquine withdrawal, knowing its role in immune modulation helps patients and doctors weigh the risks of discontinuation against potential benefits, such as reducing the risk of retinal toxicity.