Dupixent Safe, Effective Up to Four Years in Adults With Moderate-to-Severe Atopic Dermatitis

A new study of Dupixent (dupilumab) has found the safety and efficacy of the therapy lasted for up to four years in adults with moderate-to-severe atopic dermatitis (AD). The results of an interim analysis were published in the American Journal of Clinical Dermatology.

The open-label extension of LIBERTY AD is an ongoing study assessing the long-term safety and efficacy of Dupixent.

“Given that AD is a chronic relapsing disease characterized by flares and often requires continuous long-term treatment for stable disease control, analyses of long-term safety and efficacy data over time are critically important,” the authors explained.

Previous Dupixent trials analyzed the safety and efficacy of the therapy for 52 weeks and three years in adults with moderate-to-severe AD. This data had a cutoff date of March 19, 2021, and the patients studied were enrolled at approximately 550 sites in 28 countries. All of the patients had previously participated in Dupixent AD trials.

A total of 2,677 patients were included in the safety analysis set and at the data cutoff, 2,207 patients had completed up to week 52, 1,065 up to week 100, 557 up to week 148, 352 up to week 204 and 202 up to week 244.

There was a subgroup of 226 patients in this study who transitioned after 156 weeks from Dupixent 300 mg weekly to 300 mg every 2 weeks, and they were then followed for approximately 48 weeks.

The study found 2,273 patients experienced at least one treatment-emergent adverse event (TEAE), and there were a total of 14,569 TEAEs reported during the open-label extension. The researchers also found:

• 10.4% of patients experienced at least one serious TEAE
• 9.8% of patients experienced at least one severe TEAE
• 1.2% of patients experienced serious TEAEs related to the study treatment
• 3.7% of patients discontinued treatment because of TEAEs
• There were three deaths, but they were ruled unrelated to the study treatment

The most common TEAEs with 5% or greater incidence included nasopharyngitis, AD, upper respiratory tract infection, oral herpes, conjunctivitis, injection-site reaction and headache.

During the open-label extension, Eczema Area and Severity Index (EASI) and weekly average Pruritis Numerical Rating Scale (NRS) scores improved rapidly during the first several weeks with incremental improvements during the remainder of the treatment period.

Other efficacy findings included:

1. 64.4% of patients achieving Investigator’s Global Assessment score of 0 or 1 (clear or almost clear) by week 204
2. 80.8% achieved a reduction of 2 points or more in IGA
3. 94.9% achieved 50% or greater improvement in EASI, 90.9% achieved a 75% or greater improvement and 75.8% achieved a 90% or greater improvement
4. 70.8% of patients achieved a 4 point or greater improvement in weekly average Pruritus NRS score at week 204 compared with 66.9% at week 52

In the subgroup of patients who switched dosing, “measures of AD signs and symptoms were stable 48 weeks post-switch among patients who transitioned,” the authors noted. Nearly all (97.8%) of patients who switched had a low burden of itch or mild EASI score when they switched, and this response was maintained.

The authors noted several limitations including the open-label design, the lack of a placebo arm, and a smaller sample size at later time points because the study was terminated by the sponsor when Dupixent was approved in the country of study enrollment.

“The safety and efficacy data presented here support the use of dupilumab as a continuous, long-term treatment for up to 4 years for adults with moderate-to-severe atopic dermatitis,” the authors wrote in conclusion.