Clinical trials show that patients with atopic dermatitis experienced improved symptoms with dupilumab starting at 8 weeks, with maximum effect around 12 weeks.
Dupilumab was found to be the most widely used medication among new users of systemic treatments for atopic dermatitis (AD), outpacing all conventional systemic drug use, according to a study published in Pharmacoepidemiology & Drug Safety.
From 2017 through the end of the study in 2021, dupilumab use grew from 71.6% to 83.7%. Further, 92% of patients initiating dupilumab treatment in 2020-2021 were not previously administered systemic treatments.
“Our study found that a majority of patients who initiated dupilumab, were still receiving dupilumab at 90 days and beyond,” wrote study author Maria Schneeweiss, MD, Division of Pharmacoepidemiology, Department of Medicine and Department of Dermatology, Brigham and Women’s Hospital and Harvard Medical School. “This is in line with clinical trials that showed that patients experienced improvement in symptoms with dupilumab, starting at 8 weeks, with maximum effect around 12 weeks.”
Dupilumab is a human monoclonal antibody of the immunoglobulin G4 subclass that acts as an interleukin (IL)-4 receptor alpha antagonist. Dupilumab inhibits IL-4 and IL-13 signaling by specifically binding to the IL-4 receptor alpha subunit, which is shared by the IL-4 and IL-13 receptor complexes.
Dupilumab inhibits IL-4 signaling through the type 1 receptor and both IL-4 and IL-13 signaling through the type 2 receptor. Through blocking the IL-4R alpha subunit, dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, such as the release of proinflammatory cytokines, chemokines, and immunoglobulin E.
Dupilumab is the first systemic drug approved for the treatment of AD. In clinical trials, use of dupilumab showed significant improvements, however, real world data are limited in examining how dupilumab is used in the context of off-label systemic medications, according to the study authors.
Therefore, they sought to outline patterns of prescribing, switching, and discontinuing systemic AD drugs prior to and following dupilumab’s approval. The study authors also sought to understand factors associated with dupilumab prescribing.
They evaluated commercial United States insurance claims data to identify patients with AD aged 18 years and over who filled at least 1 prescription for a topical corticosteroid, calcineurin inhibitor, or PDE-4 inhibitor from 365 days prior to starting a systemic treatment for AD. Patients were randomized to a systemic therapy cohort and a dupilumab cohort.
The authors used logistic regression to evaluate the factors associated with dupilumab prescription in patients starting a systemic therapy for AD between March 2017 and February 2018 when dupilumab was approved and between March 2019 and February 2020, which was 2 years following its approval.
The study showed that the population of patients with AD who began systemic therapy increased from 219 in the 2015-2016 cohort to 1358 in the dupilumab post-approval period in 2019-2020.
In 536 patients who began systemic therapy for AD in 2017-2018, methotrexate use declined to 9.7%, which made dupilumab the most prescribed initial therapy (62.1%), with an additional 10% beginning therapy in combination with a systemic glucocorticoid.
The study found that the proportion of patients who filled a prescription for dupilumab alone was 66.2%, 60.8%, and 54.4% at 90, 180, and 365 days after cohort entry, respectively. The proportion of patients who discontinued all systemic treatment at 1 year was 35%.
Two years post approval, dupilumab remained the most prescribed treatment, with 78% of patients using dupilumab monotherapy and 5.8% using it in combination with systemic glucocorticoids. Data show that the proportion of patients who discontinued treatment at 1 year was 36%.
Dupilumab use as the initial systemic therapy for AD grew from 62% to 78% between approval in 2017-2018 to the 2 years following its approval in 2019-2020. Patients under 60 years of age were found more likely to be prescribed dupilumab, as were patients previously administered topical steroid-sparing AD agents.
Anand P, Schneeweiss S, Mostaghimi A, Schneeweiss MC. Use patterns of systemic immunomodulators in the United States before and after dupilumab approval in adults with atopic dermatitis. Pharmacoepidemiol Drug Saf. 2022 Dec 17. doi: 10.1002/pds.5586. Epub ahead of print. PMID: 36527432.