Laura is the editorial director of The American Journal of Managed Care® (AJMC®) and all its brands, including The American Journal of Accountable Care®, Evidence-Based Oncology™, and The Center for Biosimilars®. She has been working on AJMC® since 2014 and has been with AJMC®'s parent company, MJH Life Sciences, since 2011. She has an MA in business and economic reporting from New York University.
Dupilumab, with or without topical corticosteroids, significantly reduced pain and discomfort in patients with moderate to severe atopic dermatitis.
Pain is a common symptom associated with atopic dermatitis (AD) and potentially contributes to disease burden. New research published in Dermatitis showed that dupilumab, with or without topical corticosteroids (TCS), significantly reduced pain and discomfort in patients with moderate to severe AD.
“Pain is among the top 3 most frequent symptoms associated with AD, which also include itching and sleep difficulties,” the authors explained. “Pain is one of the most frequent words, identified through text mining analysis, that patients use to describe the impact of AD on their life, and pain is a close second to itch among the AD symptoms that matter to patients when determining the effectiveness of treatment response.”
The study included data from post hoc analyses of a phase 2b clinical trial and 4 phase 3 trials. These trials were all randomized, double-blind, placebo-controlled trials evaluating the safety and efficacy of dupilumab in moderate to severe AD.
The researchers measured pain in AD by using the pain/discomfort item of the 3-level version of the 5-dimension EuroQoL (EQ-5D-3L). This instrument consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 levels of response for the pain/discomfort dimension: “no pain or discomfort,” "moderate pain or discomfort,” and “extreme pain or discomfort.”
Across the trials, the proportions of patients who reported moderate to extreme pain/discomfort at baseline were similar and ranged from 72.9% to 83.1%. Less than one-fourth of patients reported no pain/discomfort at baseline.
More than half of the patients (51.4%-70.1%) treated with dupilumab 300 mg every 2 weeks (q2w) with or without TCS reported no pain/discomfort after 16 weeks of treatment. For patients treated with the 300-mg weekly dose, 48.3% to 62.7% reported no pain/discomfort. In comparison, only 19.7% to 37.0% treated with placebo with or without TCS reported no pain/discomfort.
The researchers also looked at the correlation of pain/discomfort with other AD assessments and noted that correlations were weak at baseline for AD signs, as measured by Eczema Area and Severity Index and Scoring Atopic Dermatitis (SCORAD) individual signs. However, the correlations were of moderate strength between the total SCORAD score and AD symptoms such as peak pruritus numerical rating scale and the Patient-Oriented Eczema Measure.
“The lack of strong baseline correlations between pain/discomfort and other measures of AD signs and symptoms suggests that pain may be a distinct symptom in patients with AD and should be assessed independently, both as a measure of disease burden and as an outcome of treatment benefit,” the authors wrote.
Although the assessment of patient- and clinician-reported measures allowed for the exploration of the relationship between pain and other domains was considered a strength, the broad assessment of pain/discomfort, instead of a more specific assessment of skin pain, was a limitation, they noted.
“Although further research is needed to enhance our understanding of pain in AD with regard to its prevalence and pathways of initiation and propagation, the overall implications of the accumulating data reflect the need for regular assessment of pain and its effects on AD, both in clinical trials and with regard to patient management strategies in clinical practice,” the authors concluded.
Silverberg JI, Simpson EL, Guttman-Yassky E, et al. Dupilumab significantly modulates pain and discomfort in patients with atopic dermatitis: a post hoc analysis of 5 randomized clinical trials. Dermatitis. Published online November 5, 2020. doi:10.1097/DER.0000000000000698