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Isotretinoin found safe, effective at higher dosage for severe acne

High-dose isotretinoin therapy was effective and safe compared with current standard dosing for patients with nodulocystic acne, according to study results.

Using a retrospective chart review, researchers studied 80 patients (mean age 22.9 years; 68.8% female) with nodulocystic acne who used oral isotretinoin at a dose of 1.3 mg/kg/day or greater from 2006 to 2009. Documented events, acne clearance, presence of relapse were measured. Fifty-nine participants (73.8%) completed a follow-up telephone survey that measured quality of life (QOL).

On an average of 178 days, patients received a mean daily dose of isotretinoin of 1.6 mg/kg/day resulting in a cumulative dose of 290 mg/kg. No patients discontinued treatment due to side effects or laboratory abnormalities, and no psychiatric symptoms were reported. Upon treatment completion, all patients were disease-free. Ten patients (12.5%) relapsed, requiring an additional course of isotretinoin. Following therapy, patients’ QOL domains significantly improved (self-perception, P=.0124; role-social, P=.0066; symptoms, P=.0265), according to analysis.

“The [American Academy of Dermatology, 2007] guidelines recommending relatively low cumulative dosing of isotretinoin for acne [0.5 mg/kg to 1.0 mg/kg for 20 weeks] has led to reduced efficacy and higher recurrence rates,” researcher Steven R. Cohen, MD, MPH, professor and chief of dermatology at Albert Einstein College of Medicine, Montefiore Medical Center in New York, told Healio.com. “Patients completing a high-dose treatment regimen achieved total remission of the disease, a favorable side-effect profile, a low relapse rate, and significantly improved quality of life.

“Clinicians will find our favorable side-effect profile most surprising,” Cohen said. “Despite our higher dose, we had a lower frequency of headaches and musculoskeletal effects, and the percentage of triglyceride and total cholesterol elevations was lower than in other reports.”