Anti-IL-17 Antibody Treatment for Psoriasis Not Significantly Effective for Acne

CJM112 therapy did not show significant efficacy in reducing inflammatory facial lesions in patients with moderate to severe acne.

CJM112, a potent anti-IL-17A monoclonal antibody with effectiveness in psoriasis, did not significantly reduce inflammatory lesions in patients with moderate to severe acne, according to data from a randomized, placebo-controlled, double-blind study published in the Journal of Dermatological Treatment.

Investigators randomly assigned patients aged 18 to 45 years with moderate to severe acne who had failed other systemic therapies into 3 treatment groups: CJM112 300 mg, 75 mg, or placebo via subcutaneous injection for 3 doses given 4 weeks apart. Treatment period 2 began at week 12, at which time patients receiving placebo were re-randomly assigned to receive monthly doses of either CJM112 300 mg or 75 mg from weeks 12 to 24 and the patients who received CJM112 300 or 75 mg in Treatment period 1 continued to do so. All patients completed a 13-week safety follow-up after the last dose. The primary endpoint was to determine if CJM112 was significantly better than placebo in reducing total facial inflammatory lesions at week 12, defined as at least a 30% reduction. Investigators used a Bayesian model for repeated measurements to analyze the log-transformed inflammatory lesion count.

There were 52 patients included in the study: 21 randomly assigned to CJM112 300 mg, 13 to CJM112 75 mg, and 18 to placebo. The mean age was 24.3 years and 35% were male. There were 42 patients who continued to Treatment period 2 (17 in CJM112 300 mg, 10 in CJM112 75 mg, and 6 in the placebo group). There were 11 patients who directly entered the follow-up period. Based on results from an interim analysis, the study was terminated early due to futility. At the time of the interim analysis, 14 patients in CJM112 300 mg, 3 patients in CJM112 75 mg, 5 patients in the placebo/CJM112 300 mg group, and 4 patients in the placebo/CJM112 75 mg group completed week 24.

Although there was a reduction in total inflammatory lesion count in all groups at week 12, no significant difference between groups was observed. Dermatology Life Quality Index (DLQI) scores improved in all groups as well with no differences seen between CJM112 and placebo.

Data indicates that anti-IL-17A therapy may be effective in a more inflamed acne phenotype.

Overall, 71.2% of patients experienced at least 1 adverse event in Treatment period 1 and no serious adverse events. The incidence of adverse events was higher in the pooled CJM112 groups compared with placebo, but there was no dose-response association. Infections were the most common adverse events in patients treated with CJM112, with nasopharyngitis, upper respiratory tract infection, and urinary tract infection the most frequently reported.

The study was limited by its small sample size and early termination.

Researchers noted that other study “Data indicates that anti-IL-17A therapy may be effective in a more inflamed acne phenotype.” “Further clinical studies should be undertaken to delineate the underlying role of IL-17A in driving inflammation in acne, leading to the clinical applicability of anti-IL-17 agents in the treatment of this skin disorder,” the study authors wrote.

Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. The study was funded by Novartis Pharma AG, Basel, Switzerland. Please see the original reference for a full list of disclosures.

References:

Thiboutot DM, Craft N, Rissmann R, et al. Anti-IL-17A blockade did not significantly reduce inflammatory lesions in a placebo-controlled pilot study in adult patients with moderate to severe acne. J Dermatolog Treat. Published online October 28, 2022. doi:10.1080/09546634.2022.2138691