"A scalable approach to assess the safety of recently marketed systemic" by Maria C. Schneeweiss, Robert J. Glynn et al.
 

A scalable approach to assess the safety of recently marketed systemic treatments for atopic dermatitis in clinical practice

Maria C. Schneeweiss, Dermato-Pharmacoepidemiology Work Group, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: mschneeweiss@bwh.harvard.edu.
Robert J. Glynn, Dermato-Pharmacoepidemiology Work Group, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States.
Richard Wyss, Dermato-Pharmacoepidemiology Work Group, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
Priyanka Anand, Dermato-Pharmacoepidemiology Work Group, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
Yinzhu Jin, Dermato-Pharmacoepidemiology Work Group, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
Joan Landon, Dermato-Pharmacoepidemiology Work Group, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States.
Arash Mostaghimi, Harvard Medical School, Boston, MA, United States; Department of Dermatology, Brigham and Women's Hospital, Boston, MA, United States.
Joseph F. Merola, Department of Dermatology, University of Texas, SouthWestern Medical Center, Dallas, TX, United States.
Jonathan I. Silverberg, Department of Dermatology, George Washington University, Washington, DC, United States.
David M. Rosmarin, Department of Dermatology, Indiana University, Indianapolis, IN, United States.
Robert Sidbury, Division of Dermatology, Seattle Children's Hospital, University of Washington School of Medicine, WA, United States.
Sebastian Schneeweiss, Dermato-Pharmacoepidemiology Work Group, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.

Document Type

Journal Article

Publication Date

10-1-2024

Journal

The Journal of investigative dermatology

DOI

10.1016/j.jid.2024.08.034

Keywords

Atopic dermatitis; immune-modulating drugs; medication safety; pharmacoepidemiology; real-world evidence

Abstract

Targeted systemic immune-modulating drugs (IMDs) to treat atopic dermatitis (AD) were highly efficacious in randomized trials. Trials with limited number of subjects leave questions about their safety. We describe a data and analytics structure for the production of timely, high-quality evidence on the comparative safety of recently approved IMDs in patients with AD in clinical practice. We established a series of sequential propensity score (PS)-balanced cohorts that grow in size with each annual data refresh. Nine health outcomes of interest plus conjunctivitis as a positive tracer outcome were identified. The initial treatment comparison was dupilumab, an interleukin-4/13 inhibitor, or tralokinumab, an interleukin-13 inhibitor, versus abrocitinib/upadacitinib, both JAK inhibitors. The first analysis cycle (December 2021-February 2023) compared 269 patients initiating JAK inhibitors and 2,650 initiating IL-4/IL-13 inhibitors. Patient characteristics were well balanced after PS-matching. Outpatient infections within 180 days occurred in 18% of JAK-1 inhibitor initiators versus 12% of dupilumab/ tralokinumab initiators (RR=1.50; 0.96 to 2.33) whereas acne risks were 7% vs. 3%, respectively (RR=2.29, 0.96 to 5.46). This sequential monitoring system will produce essential knowledge on the safety of IMDs to treat AD based on its growing study size of patients observed in clinical practice.

Department

Dermatology

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