Cyclosporine vs Steroids for DRESS Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments—steroids (methylprednisolone and prednisone) and cyclosporine—for drug reaction with eosinophilia and systemic symptoms (DRESS), a condition causing severe skin rashes and other serious issues. The goal is to determine which treatment is more effective and safer for those with DRESS. The study involves adults likely to have DRESS, as determined by a specific score, who do not have active infections like sepsis or hepatitis. Participants will receive either steroids or cyclosporine and may switch treatments if the first one proves ineffective. As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants a chance to contribute to groundbreaking medical knowledge.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on comparing two treatments for DRESS, steroids and cyclosporine, without mentioning changes to other medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both cyclosporine and steroids are safe for treating DRESS syndrome, a severe allergic reaction to medication. Studies have found that cyclosporine works well without causing serious side effects. Specifically, one study reported no negative effects when cyclosporine was used, suggesting it is well-tolerated by patients with DRESS.
Steroids are often the first choice for treating DRESS. Although strong evidence specifically for DRESS is limited, steroids are well-known and widely used for many conditions. They help by reducing inflammation, decreasing swelling and redness in the body.
Both treatments are part of the standard care for DRESS, meaning doctors use them regularly because they are considered safe and effective. This trial aims to determine which one works better, but both have a good safety record based on current information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for DRESS Syndrome because they offer different approaches compared to the usual steroid-based therapies. Cyclosporine, typically used for its immune-suppressing abilities in transplant patients, is being evaluated here for its potential to rapidly control the overactive immune response seen in DRESS. Unlike standard corticosteroid treatments, which can take longer to taper and manage, cyclosporine might provide a quicker resolution of symptoms by targeting T-cell activation more directly. The corticosteroid regimen, on the other hand, is being explored for its precise tapering strategy, potentially reducing the side effects typically associated with prolonged steroid use. These innovative strategies could lead to faster recovery and fewer complications for patients.
What evidence suggests that this trial's treatments could be effective for DRESS?
This trial will treat participants with either cyclosporine or corticosteroids to determine which is more effective for DRESS syndrome. Previous studies have shown that cyclosporine often leads to improvements in fever and rash within about 4 days. Research also indicates that cyclosporine can be beneficial when long-term steroid use isn't possible. Conversely, steroids are a standard treatment for DRESS, helping to control inflammation and symptoms. Both treatments offer potential benefits, but clear comparisons between them remain necessary. This study aims to identify which treatment works better for DRESS.36789
Are You a Good Fit for This Trial?
Adults with a likely diagnosis of DRESS (a severe skin reaction to drugs) as indicated by a RegiSCAR score over 4 can join this trial. It's not for those who have allergies to steroids or cyclosporine, active hepatitis B/C, sepsis, tuberculosis, or severely reduced kidney function unless they're on dialysis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either corticosteroids or cyclosporine based on randomization to compare efficacy in treating DRESS
Follow-up
Participants are monitored for safety and effectiveness after treatment, including resolution of symptoms and any adverse effects
Long-term monitoring
Participants are monitored for long-term outcomes such as autoimmune development and viral reactivation
What Are the Treatments Tested in This Trial?
Interventions
- Cyclosporine
- Methylprednisolone and Prednisone
Trial Overview
The study compares two standard treatments for DRESS: Cyclosporine versus Steroids (Methylprednisolone and Prednisone). This pilot RCT aims to determine which treatment is more effective without additional procedures beyond routine care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
All Patients start with 500 mg IV Methylprednisolone for 3 days 1\. If \>25% improvement (must be \>25% in all involved organs), start the taper regimen 2. If 0-25% improvement (in ≥1 involved internal organ), give 500 mg IV Methylprednisolone for 4 days 1. If no improvement, switch to cyclosporine arm of treatment 2. If 0-25% improvement, give 500 mg IV Methylprednisolone for 3 days i. If labs are down-trending, start the taper regimen ii. If labs are not down-trending, switch to cyclosporine arm of the study c. If \>25% improvement, start the taper regimen Taper Regimen set as: 1. 125 mg IV Methylprednisolone x3 days 2. 1.2 mg/kg PO prednisone x1 week 3. 1 mg/kg PO prednisone x1 week 4. 0.8 mg/kg PO prednisone x1 week 5. 0.6 mg/kg PO prednisone x1 week 6. 0.4 mg/kg PO prednisone x1 week 7. 0.2 mg/kg PO prednisone x1 week 8. 0.1 mg/kg PO prednisone x1 week 9. 0.05 mg/kg PO prednisone x1 week
All Patients start with 5 mg/kg/day (3 mg/kg/day if renal impairment) PO divided bid for 7 days (or IV if patient is NPO) 1. If complete resolution, stop cyclosporine and monitor closely for relapse a. If patient relapses, give 5 (3 if renal impairment) mg/kg/day PO divided bid PO for 7 days i. If down-trending, start oral taper regimen ii. If not down-trending, switch to steroid arm 2. If \>25% improvement and labs are down-trending, start the oral taper regimen. 3. If 0-25% improvement, give 5 (3 if renal impairment) mg/kg/day PO divided bid for 3 days 1. If down-trending, start oral taper regimen 2. If not down-trending, switch to steroid arm 4. If no improvement or up-trending labs at 7 days, switch to steroid arm Oral Taper Regimen set as 3 mg/kg PO divided bid for 14 days, then 2 mg/kg PO divided bid for 20 days. If renal impairment, oral taper regimen set as 2 mg/kg PO divided bid for 14 days, then 1 mg/kg PO divided bid for 20 days
Cyclosporine is already approved in European Union, United States, Canada, Japan for the following indications:
- Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
- Treatment of severe psoriasis
- Treatment of nephrotic syndrome
- Prevention of organ rejection in kidney, liver, and heart transplants
- Treatment of severe rheumatoid arthritis
- Treatment of severe psoriasis
- Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
- Treatment of severe psoriasis
- Treatment of nephrotic syndrome
- Prevention of organ rejection in kidney, liver, and heart transplants
- Treatment of severe rheumatoid arthritis
- Treatment of severe psoriasis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Published Research Related to This Trial
Citations
Cyclosporine in the Treatment of Drug Reaction With ...
Our study supports the use of cyclosporine in the treatment of DRESS syndrome, particularly in patients who are unable to sustain prolonged immunosuppression.
The systemic treatments for drug reaction with eosinophilia ...
On average, fever resolution and rash improvement occurred approximately 4.1 days after starting cyclosporine, demonstrating effective outcomes, although its ...
Evaluation of Cyclosporine for the Treatment of DRESS ...
This retrospective case-control study of 26 adults evaluates the use of cyclosporine A in the treatment of drug reaction with eosinophilia ...
NCT04988256 | Cyclosporine Vs Steroids in DRESS
Data suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of ...
Successful treatment of corticosteroid-dependent drug ...
The patients had marked cutaneous improvement and normalization of liver function and eosinophil count after adding cyclosporine, and the ...
First-line therapy in drug reaction with eosinophilia and ...
A variety of dosing strategies are used, ranging from initial intravenous methylprednisolone pulse treatment (10–30 mg/kg/dose) to oral ...
Drug Reaction with Eosinophilia and Systemic Symptoms ...
Unfortunately, the management of drug rash with eosinophilia and systemic symptoms syndrome is not well supported by strong evidence-based data. Drug rash with ...
DRESS syndrome: A literature review and treatment ...
Several indicators of poor prognosis have been identified and these include an eosinophil count above 6000 × 103/μL, thrombocytopenia, pancytopenia, ...
9.
worldallergyorganizationjournal.org
worldallergyorganizationjournal.org/article/S1939-4551(24)00066-8/pdfThe systemic treatments for drug reaction with eosinophilia ...
presented that a series of pediatric patients with severe DRESS were treated successfully with IVIG in addition to systemic corticosteroids with.
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