Dupilumab Found Effective, Safe as Long-Term Treatment in Adults With Atopic Dermatitis

Atopic dermatitis (AD) could be safely and effectively treated in adults who need long-term treatment, according to 2 posters presented during Fall Clinical Dermatology 2023. The posters reported on the results of an open-label extension trial that took place over 5 years.

AD is often treated with topical therapies but aren’t always sufficiently controlled when at the moderate-to-severe level. Systemic immunosuppressants present safety concerns for long-term treatment. Therefore, these 2 posters aimed to assess the long-term efficacy and safety of dupilumab in patients who had moderate-to-severe AD.

The first poster¹ used data from the LIBERTY AD OLE phase 3 trial that lasted for 5 years and distributed dupilumab 300 mg weekly to adults who had previously participated in clinical trials for dupilumab. Every 2 weeks 226 patients transition to 300 mg to keep with approved dosage. Topical corticosteroids and topical calcineurin inhibitors were among the concomitant treatments that were allowed in the trial. The LIBERTY AD CHRONOS safety results for adults with moderate-to-severe AD at 52 weeks who were receiving dupilumab 300 mg were provided as a comparison due to a lack of a control arm. The analysis covered all patients who were treated up to 5 years.

Close up dermatitis on skin, ill allergic rash eczema skin of patient, atopic dermatitis symptom skin detail texture, Fungus of skin, The concept dermatology, treatment fungal | Image credit: Irina - stock.adobe.com

A total of 2677 patients were included int his study, of which 60.2% were male and 72.3% were White; the patients had a mean (SD) age of 39.2 (13.4) years and had a mean AD duration of 29.9 (14.8) years. The mean baseline Eczema Area and Severity Index (EASI) score was 32.8 (13.2) and the mean Peak Pruritus Numerical Rating Scale (PP-NRS) score was 7.1 (1.9) during the parent study. The OLE baseline mean EASI was 16.4 (14.6) and the PP-NRS score was 5.0 (2.5). A total of 12.5% of all patients completed up to week 260 of the trial and 48.4% were deemed as having completed the study.

There were 76.2% of patients who achieved EASI-90 scores at the end of the study, up from approximately 40% at baseline. Patients reporting EASI-75 also improved from approximately 65% at baseline to 88.9% at the end of the study. A total of 66.5% of patients achieved a 4-point reduction in PP-NRS score by the end of the study, which is an improvement from approximately 45% at baseline.

The researchers concluded that the long-term study proved that dupilumab had continued efficacy through 5 years with sustained improvement of signs and symptoms of AD. The safety profile was also deemed to be acceptable and consistent.

The second poster_² aimed to report on the long-term safety of dupilumab in the same study. All data and eligibility criteria explained above applied to this study, with data presented including the safety analysis for the overall study population of OLE.

As mentioned previously, the total number of patients was 2677, with 60.2% male and 72.3% White patients included. The mean age was 39.2 (13.4) years and the mean EASI, Investigator’s Global Assessment (IGA), and PP-NRS scores were 16.4 (14.6), 2.7 (1.0), and 5.0 (2.5) respectively. A total of 1297 patients (48.4%) completed the study.

A total of 85.0% reported at least 1 treatment emergent adverse event (TEAE), with 10.0% reporting a severe TEAE, 10.6% reporting a severe adverse event, and 1.2% reporting a severe adverse event that was related to treatment; 3.8% discontinued treatment due to TEAEs. The most common TEAEs included nasopharyngitis (28.9%), conjunctivitis (20.0%), atopic dermatitis (16.7%), upper respiratory tract infection (13.6%), headache (8.1%), oral herpes (7.5%), and injection site reaction (5.2%).

The researchers found that there were 894 conjunctivitis events in total, with 87.7% of them being resolved or recovered from. A total of 1.1% reported recovering with sequelae, 1.9% reported actively recovering, and 9.2% reported not recovering. There were 536 patients who reported at least 1 event of conjunctivitis, of which 46.3% were mild, 48.7% were moderate, and 5.0% were severe. A total of 48.1% of cases were found to be related to the study drug and 2.6% discontinued the drug due to their conjunctivitis diagnosis.

The researchers concluded that the safety profile was acceptable and consistent with previous data. The incidence rates of TEAEs that were exposure-adjusted did not increase over time and were lower overall compared with the 3-year and 4-year analyses of the OLE trial as well as the 52-week placebo-controlled trial. A total of 95% of patients who received a TEAE reported it as mild or moderate and more than 85% of events were reported as recovered or resolved.

References

1. Beck LA, Bissonnette R, Deleuran M, et al. Long-term efficacy of dupilumab in adults with moderate-to-severe atopic dermatitis: results from a 5-year open-label extension trial. Presented at: Fall Clinical Dermatology 2023; October 19-October 22, 2023; Las Vegas.
2. Beck LA, Bissonnette R, Deleuran M, et al. Safety of long-term dupilumab treatment in adults with moderate-to-severe atopic dermatitis: results from a 5-year open-label extension trial. Presented at: Fall Clinical Dermatology 2023; October 19-October 22, 2023; Las Vegas.