Nonresponse was common among patients with moderate to severe atopic dermatitis (AD) treated with a systemic immunosuppressive (SIS) agent or with dupilumab. Indicators of nonresponse were more frequent and time to nonresponse considerably shorter for those treated with SIS agents. These are some of the findings from an analysis published in Advances in Therapy.
SIS agents (methotrexate, cyclosporine, mycophenolate, azathioprine) are not approved by the FDA for atopic dermatitis although sometimes indicated in severe cases. The possibility of cumulative toxicity of these medications discourages long-term use. For patients who do not respond to topical treatment or phototherapy, SIS agents or the biologic agent dupilumab may be an option. Researchers aimed to assess the real-world effectiveness of SIS and dupilumab for moderate-to-severe AD.
They initiated a retrospective cohort analysis of data from September 2016 (6 months before FDA approval of dupilumab) through December 2019 from the IQVIA Health Plan Claims data set (IQVIA, Danbury, CT) from health plans in the United States. Included were 3249 patients (54.2% female) with AD who were at least 12 years of age. All were enrolled for at least 6 months before and 6 months after the index date (date of the first claim of systemic treatment), and all were treated with either an SIS agent (methotrexate, cyclosporine, mycophenolate, or azathioprine) or dupilumab.
Most common comorbidities included atopic disorders, 35.5% followed by psychological disorders (27.8%). Baseline was the 6 months before the index date. Investigators searched for indicators of nonresponse (AD-related inpatient/emergency room visits, adding on/switching systemic therapy, incident staphylococcal/streptococcal skin infection) and predictors of nonresponse.
Among all patients, more than 45% presented at least 1 indicator of nonresponse. Median time to nonresponse was considerably shorter for SIS therapies (4.0-7.7 months) than for dupilumab (27 months). Of the nonresponse predictors, geographic region, age, and baseline number of annual AD-related medical visits were the main factors.
Researchers acknowledged analysis limitations that include the unreliability of insurance claims-based indicators as proxy variables, unaccounted for treatment switching in multiple cases unrelated to response, unassessed treatment adherence impacting measure of nonresponse, follow-up time too short for long-term assessment, AD frequently incorrectly identified using ICD codes resulting in misclassification, and generalizability extending only to the narrow data base.
Researches said their analysis suggested that, “Nonresponse was common in patients with AD who required systemic treatment, and nonresponse indicators occurred significantly more frequently with SIS treatment than with dupilumab treatment.”
Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This research was supported by Pfizer Inc., New York, NY, USA.
Wu JJ, Lafeuille MH, Emond B, et al. Real-world effectiveness of newly initiated systemic therapy for atopic dermatitis in the United States: a claims database analysis. Adv Ther. Published online July 12, 2022. doi:10.1007/s12325-022-02197-z