VUMC researchers have reported promising results in using oral antimycobacterial therapy to treat chronic cutaneous sarcoidosis, considered by clinicians a difficult illness to effectively control.
Wonder Drake, M.D., associate professor of Medicine, and colleagues wrote in JAMA Dermatology, that patients in the randomized, placebo-controlled, single-masked trial showed reductions in lesion diameter and a clinically significant improvement in symptoms.
In the study, participants were randomized to receive either a four-drug regimen called CLEAR (concomitant levofloxacin, ethambutol, azithromycin and rifampin) or a comparative placebo regimen for eight weeks with a 180-day follow-up.
“It’s very exciting, but the results are preliminary,” Drake said of the Phase I trial involving 30 patients.
She noted that one problem in using a four-drug combination is the increase in chances for side effects of the various medications, so patients must be carefully monitored while taking the drugs.
Typical treatment for the disease involves the use of various topical medications, usually with only temporary success.
Sarcoidosis is a varied disease that strikes many organ systems in the body, and the positive findings in this skin-based variety, if confirmed, may prove to also be helpful in treating other varieties of sarcoidosis, Drake said.
To that end, Drake and Gordon Bernard, M.D., associate vice chancellor for Clinical and Translational Research, recently received funding for a Phase II multicenter trial to investigate whether a similar antimycobacterial therapy approach might be useful in treating chronic pulmonary sarcoidosis, the lung-based form of the disease. Pulmonary sarcoidosis is generally more serious than the skin-based variety.
The $2.8 million grant from the National Institutes of Health will support the study at VUMC, along with partners at the Cleveland Clinic and the University of Cincinnati.
“We want to do this study in such a rigorous manner that, if it shows promise, the results will be embraced [by clinicians],” Drake said.
The study was supported in part by grants HL103179, HL069765, HL094296, HL112694, and RR024975 from the NIH; the Foundation for Sarcoidosis Research; the Dorothy P. and Richard P. Simmons Endowed Chair for Pulmonary Research; the Mona Eliassen Foundation; and the Pierce Family Foundation.
