Dupilumab Considered Safe, Effective for AD in Real-Life Settings

Dupilumab is an effective and safe treatment option for patients with atopic dermatitis (AD) in real-life settings, including those with malignancy and other medical comorbidities, according to a study published in Journal of the American Academy of Dermatology International.

The researchers explained that, in 2017, dupilumab became the first treatment approved in Canada for moderate to severe AD, as multiple clinical trials demonstrated its effectiveness and safety. However, they noted that these clinical trials may not provide a complete representation of the patient population, or reflect the drug’s actual clinical efficacy and safety in real-life patients, due to the strict inclusion and exclusion criteria.

Because of this, the researchers aimed to “bridge the gap” between clinical trial outcomes and real-world experience by conducting a retrospective analysis of patient records, including those with other significant comorbidities, to describe the effectiveness of dupilumab in practice.

“…the findings of this study could help health care providers make better informed decisions and tailor treatment approaches to better suit the rare needs and characteristics of patients they encounter in their daily practice,” the authors wrote.

Only 6% of the study population reported having an injection site reaction after being treated with dupilumab | Image Credit: Irina Schmidt - stock.adobe.com

To do so, they searched the patient records of dermatology clinics at Hamilton Health Sciences Centre and/or McMaster University from December 1, 2017, to July 31, 2023. Eligible patients included adults with a clinical diagnosis of moderate to severe AD who had Physical Global Assessment (PGA) scores of 3 or 4 and received dupilumab for 52 weeks. The researchers collected various data from the records, including patient demographics, age of AD onset, AD duration, and related comorbidities.

The researchers also collected data on treatments used before dupilumab, like methotrexate (MTX), narrowband UV-B (NB-UV-B), and cyclosporine. Additionally, they gathered PGA scores for each patient, and Eczema Area and Severity Index (EASI) scores when available, before and at week 52 of dupilumab treatment. Lastly, the researchers collected data on dupilumab adverse effects, including injection site reactions (ISRs), arthropathy, ocular surface disease, and facial and neck redness.

The study population consisted of 155 eligible adult patients. The population was made up of 69 (45%) male patients and 86 (55%) female patients. Also, the mean (SD) age of the patients was 40 (17.85) years (range, 18-86 years), and the average AD duration was 15.28 years.

Additionally, 123 (79%) patients received either NB-UV-B and/or at least 1 systemic agent (MTX and cyclosporine) before beginning dupilumab. The researchers noted that 94 (61%) patients used MTX before starting dupilumab, making it the most used predupilumab agent; cyclosporine and NB-UV-B were used by 34% and 25% of patients, respectively, before dupilumab.

Of the population, 99 patients achieved PGA scores of 0 or 1 at week 52 of dupilumab use. EASI scores were available for 88 patients, 62 (70%) of whom achieved EASI-75 at week 52; the average EASI scores before and after dupilumab use were 22 and 4.3, respectively. Also, adverse events, more specifically ISRs, ocular surface disease, facial and neck redness, and arthropathy, occurred in 6%, 10%, 8%, and 6% of patients, respectively.

Lastly, the study population included 3 pregnant patients with AD who continued using dupilumab throughout their pregnancy. The researchers noted that all 3 patients maintained PGA scores of 0 or 1, and there was no reported impact on pregnancy, delivery, or the newborn. Similarly, the study population contained 12 patients with prior or active malignancy being treated with dupilumab, none of whom reported a negative impact on malignancy.

The researchers acknowledged their study’s limitations, such as its retrospective design and relatively small population size. Another limitation was the lack of quality control surrounding data collection in real-world settings. They explained that further studies with longer follow-ups, larger cohorts, and more diverse patient populations are needed to better understand the real-life practice of dupilumab use in patients with AD. Despite this, the researchers expressed confidence in their findings, noting that further studies will strengthen them.

“As more studies continue to monitor the efficacy of dupilumab in patients with AD and additional comorbidities, clinicians can make more informed and evidence-based decisions to tailor treatment and improve treatment outcomes,” the authors concluded.

Reference

Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11. doi:10.1016/j.jdin.2024.01.002