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Long-Term Efficacy and Safety of Dupilumab for Atopic Dermatitis

<ѻý class="mpt-content-deck">– Many maintained disease control out to 5 years; adverse events caused significant drop-outs

In a study in , dupilumab maintained clinical effectiveness out to 5 years for many patients with atopic dermatitis (AD). Two-thirds of participants tapered to a regular dosing interval of every 3-4 weeks. About 24% of patients discontinued dupilumab during the trial period, primarily due to adverse events (AE) or general ineffectiveness.

In total, 1,286 patients with AD were treated with dupilumab as part of the trial; participants included 130 children, 1,025 adults, and 131 older adults. Median follow-up time was about 88 weeks.

Most patients maintained control of their AD and related symptoms during the trial period; Eczema Area and Severity Index (EASI) scores averaged 7 or lower and Numerical Rating Scale (NRS) for pruritus scores were 4 or lower. Mean EASI and NRS for pruritus scores were 2.7 (95% CI 1.2-4.2) and 3.5 (95% CI 2.7-4.3), respectively, after 5 years of treatment.

Additionally, about 70% of participants prolonged a dosing interval of mostly 300 mg every 3-4 weeks.

The prospective multicenter cohort study was conducted using data from four academic and 10 nonacademic hospitals in The Netherlands. The following paper excerpts have been edited for length and clarity.

What was the context or background for this investigation?

Since it initially reached the market in 2017, dupilumab has received extended indications for adolescents (>12 years) with moderate-to-severe AD; children (≥6 months) with severe AD; and patients with severe allergic asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.

Further, recently published studies on tapering of dupilumab in patients with AD have shown that prolonging dosing intervals was successful and safe. One trial reported follow-up results of up to 4 years, while most daily practice studies only described results out to 2 years of treatment.

The aim of the current study was to assess the clinical effectiveness of dupilumab in a large cohort of patients with AD with follow-up of up to 5 years of treatment in daily practice. The secondary aim was to evaluate the frequency and reasons for dupilumab treatment discontinuation.

What were the central findings?

In this daily practice study, dupilumab showed clinical effectiveness, with clinical response maintained for most patients through the entire observation period. A fairly similar response emerged among children, adults, and older adults.

However, while dupilumab treatment was effective in most patients, 306 patients (23.8%) discontinued treatment after a median of 54 weeks. Adverse events among 98 (7.6%) patients and ineffectiveness among 85 (6.6%) patients were the most frequently cited reasons.

This rate of discontinuation is slightly higher than what was previously reported in daily practice studies that reported up to 2 years of follow-up.

Which adverse events were the most common cause of discontinuation?

Of those who discontinued dupilumab because of AEs, dupilumab-associated ocular surface disease was the most frequently cited reason for dropout, followed by muscle/joint pain and lymphoid reactions. A total of 218 patients stopped treatment to pursue other new advanced systemic drugs that had become available for the treatment of AD.

What are the paper's key takeaways for dermatologists?

Researchers, citing experiences in clinical practice, observed that successful dose reduction relies on patient motivation and physician-associated factors, such as adequately informing patients about the possibility of marginal flaring or emphasizing the importance of temporarily increasing topical corticosteroid use.

Furthermore, researchers noted that pediatric population tended to have slightly higher EASI scores compared with older patients in the study. However, these differences were rather small.

Primary Source

JAMA Dermatology

Source Reference:

AAD Publications Corner

AAD Publications Corner