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A year-long study showed dupilumab alone effectively prevented flares in moderate to severe atopic dermatitis, with consistent safety across various dosing schedules.
A poster presented at the Society of Dermatology Physician Associates (SDPA) Annual Summer Dermatology Conference highlighted the effectiveness of dupilumab (Dupixent; Regeneron Pharmaceuticals and Sanofi) in provided sustained, long-term flare control in adult patients with moderate to severe atopic dermatitis (AD).1
The analysis assessed data from the phase 3 SOLO 1/2 (NCT02277743; NCT02277769)2-3 and SOLO-CONTINUE extension (NCT02395133)4 trials. The investigation focused on the extent to which dupilumab can prevent flare episodes over a full year of continuous treatment.
Unlike previous studies combining dupilumab with topical corticosteroids, the present analysis centered solely on dupilumab administered alone, without adjunct therapies, to determine its standalone efficacy and safety in maintaining disease control.
Participants in the study had already responded favorably to a 16-week initial treatment phase, receiving treatment with dupilumab 300 mg once per week or once per every 2 weeks. Those who demonstrated significant improvement defined by achieving an Investigator's Global Assessment score of 0/1 (indicative of complete or almost complete clearance) or at least a 75% improvement in Eczema Area and Severity Index were eligible for extension into the next phase of the trial.
During this phase, more than 160 adults were randomized into different maintenance dose groups: 300 mg every 2 weeks, 300 mg every 4 weeks, and 300 mg every 8 weeks. The study then tracked the occurrence of flares, defined as worsening requiring treatment escalation, and analyzed the duration until the first flare event.
Approximately 80% of patients (equivalent to 8 of every 10 patients) across all dosing schedules remained well-controlled, with no disease flares observed throughout the duration of the 1-year follow-up.
The duration of time from baseline to first observed flare was significantly delayed in patients treated with dupilumab, regardless of whether they received injections every 2, 4, or 8 weeks.
The safety profile was consistent with known data on dupilumab, with most adverse events being mild to moderate in nature. Serious adverse events were rare, and no treatment-related deaths occurred.
"Dupilumab monotherapy over 1 year prevented flares in 8 out of 10 patients regardless of the maintenance dose regiment," wrote poster authors Simpson et al.
The findings suggest that dupilumab monotherapy is highly effective in maintaining disease control over an extended period, emphasizing its role as a sustainable long-term solution in AD management.
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