The safety and efficacy of systemic isotretinoin for the treatment of moderate to severe acne was supported by study data published in Dermatologic Therapy. In an observational cohort study of patients who failed to respond to other systemic acne treatments, oral isotretinoin was associated with significant improvements in acne severity and dermatology-related quality of life.
Patients with moderate to severe acne who had not experienced acne improvements from other systemic treatments were recruited from a dermatology clinic in Italy. All patients were given at least 1 and up to 3 cycles of systemic oral isotretinoin. Women enrolled in the study received oral contraception according to current systemic isotretinoin treatment guidelines. At baseline, patients underwent acne severity assessment using the Global Acne Grading System (GAGS). Quality of life was measured with the Acne of Quality of Life (AQoL). Acne severity and quality of life were re-assessed at the end of the first treatment cycle. The primary outcomes were clinical improvement on the GAGS and advanced quality of life. Adverse events were monitored throughout the trial.
A total of 100 patients were enrolled, of whom 59 were men. Moderate acne was observed in 64 patients; severe acne was observed in 36. Mean age at initiation of oral isotretinoin was 22.2 years (range, 16-40); mean isotretinoin cycle duration was 7.68 months. On average, women had an older mean age at isotretinoin initiation compared with men (26.5 vs 19.4 years). Daily mean dose of isotretinoin was 0.41 mg/kg (range, 0.2-06 mg/kg/day).
Mean GAGS score decreased from 27 (range, 9-38) at baseline to 3 (0-16) after completion of first cycle. Mean AQoL increased from 60 (range, 14-95) to 90 (40-110). Magnitude of GAGS and AQoL improvement was greater in patients with moderate compared with severe acne, although both groups experienced improvements. Higher isotretinoin cumulative doses were associated with greater GAGS and AQoL improvements. Specifically, GAGS score increased by 65%, 85%, 92%, and 93% in the low (<80 mg/kg), low-medium (80-100 mg/kg), medium-high (100-120 mg/kg), and high (>120 mg/kg) dosing groups, respectively. Similarly, improvement from baseline in AQoL was 21% in the low dose group, 30% in the low-medium group, 33% in the medium-high group, and 35% in the high dose group. It was noted that 9% of patients experienced acne recurrence within 1 year of treatment cycle completion. This percentage was higher in women compared with men (12% vs 6%) and among low-dose compared with high-dose groups.
Overall, 80% of patient experienced at least 1 adverse event. The most common events were skin xerosis and cheilitis (87%), epistaxis, headache, myalgia, and blurring of vision. All adverse events resolved over time. Xerosis and cheilitis were managed by topical emollients. No psychiatric adverse events were observed. No patients displayed symptoms of inflammatory bowel disease.
Results from this observational study support the efficacy of systemic isotretinoin for reducing moderate to severe acne. Patients taking oral isotretinoin also experienced significant improvements in quality of life. No new safety signals were observed. “[I]n the era of antibiotic resistance risk awareness, or in patients with known allergy reactions, as well as in those with high risk for scar formation, an early systemic isotretinoin treatment of moderate acne could be taken into consideration as a valid therapeutic approach,” investigators wrote.
Tolino E, Skroza N, Proietti I, et al. Efficacy and safety of systemic isotretinoin treatment for moderate to severe acne (insights from the real-life clinical setting) [published online October 9, 2020]. Dermatol Ther. doi: 10.1111/dth.14392