A combination therapy comprising tacrolimus ointment and dupilumab appears safe and effective for atopic dermatitis (AD) on the face, according to data from a retrospective study published in The Journal of Dermatology.

The study included a total of 109 Japanese patients with AD who first received dupilumab from 2018 to 2020. Approximately 55% of patients in the single-center study also received tacrolimus ointment. Patients included in the final retrospective analysis were those who used tacrolimus ointment on the head and neck after dupilumab. The study treatment lasted for 16 weeks.

The majority of patients (75%) received 0.1% tacrolimus ointment, and the remaining 6 patients received tacrolimus ointment at a concentration of 0.03%. During the study, only 1 patient had the concentration of their drug changed from 0.03% to 0.1%.


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At the end of 16 weeks, patients had a 50% reduction in their Investigator’s Global Assessment (IGA), a 70% reduction in the overall Eczema Area and Severity Index (EASI), a 74.7% reduction in head/neck EASI, a 73.6% reduction in the Patient-Oriented Eczema Measure (POEM), and a 93.6% reduction in serum thymus- and activation-regulated chemokine (TARC) levels.

There was a significant correlation between the rate of improvement in head/neck EASI and the overall EASI improvement rate (P <.01).

Conjunctivitis, a known risk of dupilumab treatment, was reported in 10% of the 20 patients treated with dupilumab on the head and neck. None of these 20 patients developed herpes simplex; however, approximately 7.5% of 40 patients who received the combination therapy with topical steroids on the head and neck developed this viral infection.

Limitations of this study included its retrospective design as well as the limited duration of follow-up. As such, the researchers were not able to examine the risk of rosacea-like dermatitis, a possible complication of long-term continuous use of topical tacrolimus.

In an explanation of how the therapy might work in facial AD, the investigators noted that given “tacrolimus is reportedly capable of inhibiting the growth of Malassezia,” the topical ointment containing the therapy “may have effectively improved these facial skin rashes by inhibiting Malassezia, for which dupilumab” is ineffective.

Reference

Matsutani M, Imai Y, Inoue Y, et al. Effectiveness and safety of tacrolimus ointment combined with dupilumab for patients with atopic dermatitis in real-world clinical practice. J Dermatol. Published online June 22, 2021. doi:10.1111/1346-8138.16039