Cyclosporine vs Steroids for DRESS Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Trial Summary

What is the purpose of this trial?Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids and cyclosporine. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis. This will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with 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 these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) \< 30 (unless on dialysis in which case the participants will be included).

Eligibility Criteria

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

You have a high RegiSCAR score, which suggests you may have a serious skin reaction called DRESS.

Exclusion Criteria

I have active tuberculosis.

My kidney function is low, but I am on dialysis.

You have a confirmed allergy to steroids or cyclosporine.

+2 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: CorticosteroidsExperimental Treatment1 Intervention

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

Group II: CyclosporineActive Control1 Intervention

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:

🇪🇺 Approved in European Union as Neoral for:

Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
Treatment of severe psoriasis
Treatment of nephrotic syndrome

🇺🇸 Approved in United States as Neoral for:

Prevention of organ rejection in kidney, liver, and heart transplants
Treatment of severe rheumatoid arthritis
Treatment of severe psoriasis

🇨🇦 Approved in Canada as Neoral for:

Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
Treatment of severe psoriasis
Treatment of nephrotic syndrome

🇯🇵 Approved in Japan as Neoral for: