Real-World Study Finds Dupilumab Safe, Effective for Moderate-to-Severe Atopic Dermatitis

A real-world analysis of Korean patients with moderate-to-severe atopic dermatitis (AD) showed that treatment with dupilumab provided significant improvement in skin clearance that was maintained after one year. Findings were published in Allergy, Asthma & Immunology Research.

As the first biologic drug approved for use in the treatment of moderate-to-severe AD in adult patients, dupilumab serves as a human monoclonal antibody against the interleukin (IL)-4 receptor α-subunit (IL-4Rα) that inhibits IL-4 and IL-13 signaling.

With prior research having shown the effectiveness and safety of the drug in randomized controlled trials involving children and adults with moderate-to-severe AD, researchers sought to explore whether these observed benefits translated to the real-world setting.

“As the use of dupilumab is growing exponentially worldwide, the importance of reporting/ sharing the accumulating experience with dupilumab in clinical practice cannot be stressed enough,” the study authors explained. “Minute differences in terms of nationality, race, or insurance plan can potentially result in meaningful differences in the use of and response to dupilumab.”

They conducted a retrospective real-world analysis of the electronic medical records of adult patients with moderate-to-severe AD who were administered dupilumab at Seoul National University Hospital or Seoul National University Bundang Hospital in South Korea between August 2018 to October 2019 (N = 40; mean age, 30.9 years; 72.5% male).

Participants provided baseline and follow-up disease severity data, including Eczema Area and Severity Index (EASI) scores and photographic records, as well as the Investigator's Global Assessment (IGA) score to evaluate face and hand skin clearance.

“All the patients were administered the standard protocol of 600 mg of dupilumab at week 0 and 300 mg every 2 weeks thereafter,” researchers said. “In addition, any and all adverse events during dupilumab treatment, including conjunctivitis, paradoxical head and neck erythema, and alopecia, were collected from the medical records.”

At baseline, the mean EASI score was 28.2, 64.9% (24 of 37) of the patients had moderate-to-severe facial eczema with IGA scores of 3 or 4, and 28.6% (10 of 35) of the patients had moderate-to-severe hand eczema with IGA scores of 3 or 4.

By week 8, mean EASI scores dropped significantly to 7.2, with following scores at weeks 16, 24, 40, and 52 shown as 3.4, 5.2, 4.7, and 3.2, respectively. Data from the last follow-up also indicated that 95.8% and 90% of the moderate-to-severe facial and hand lesions, respectively, improved to IGA scores of 0 or 1.

“Notably, the therapeutic effect was maintained despite the considerable number of patients requiring an increase in treatment intervals due to the financial burden in a real clinical setting.”

Furthermore, 2 patients were able to discontinue dupilumab treatment after achieving complete clearance of AD symptoms (EASI and IGA scores of 0) for more than 3 months, with no flare-up events reported in these patients. Treated with topical corticosteroids alone after discontinuation, one of the patients has been completely disease-free for 43 weeks and the other has been maintaining an IGA score of 1 for 66 weeks.

Regarding safety, 7 of the 40 patients (17.5%) reported 9 adverse events in total. Conjunctivitis was the most frequent adverse event (15%) and it generally responded well to conventional treatment. Incidence of paradoxical head and neck erythema/dermatitis (2.5%) was found to be rare in the study group.

Researchers concluded that future prospective studies are warranted to elucidate the different treatment responses and adverse events in a broader population.

Reference

Lee H, Kim BR, Kim KH, Lee DH, Na JI. One-year effectiveness and safety of dupilumab treatment for moderate-to-severe atopic dermatitis in Korean patients: A real-world retrospective analysis. Allergy Asthma Immunol Res. Published online October 27, 2021. doi:10.4168/aair.2022.14.1.117