DOI 10.1016/j.jdin.2025.05.023
Originator versus biosimilar adalimumab in hidradenitis suppurativa: A multicenter real-world analysis of clinical response, maintenance of response, and switching.
Аннотация
BACKGROUND
Adalimumab is a mainstay treatment for hidradenitis suppurativa (HS); however, high-costs limit accessibility. While biosimilars offer an affordable alternative, concerns remain regarding clinical equivalence and the impact of switching.
OBJECTIVE
To evaluate the clinical response of originator versus biosimilar adalimumab in HS and assess outcomes following nonmedical switching.
METHODS
This multicenter, real-world study included treatment naïve HS patients initiated on originator or biosimilar adalimumab between April 2021 and December 2024. Outcomes were compared between patients remaining on originator and those switched to biosimilar after 16 weeks. Clinical responses were assessed using Hidradenitis Suppurativa Clinical Response 50, Hidradenitis Suppurativa Clinical Response 75, and International Hidradenitis Suppurativa Severity Scoring System 55, with time-to-event analyses evaluating loss of clinical response.
RESULTS
Patients on originator adalimumab (n = 186) demonstrated greater proportions of clinical response than biosimilars (n = 127), with time-to-event analysis showing a significant difference between curves (100 vs 52 weeks; hazard ratio = 2.73; P < .0001). Patients switched to biosimilars (n = 71) and experienced higher rates of loss of response than those maintained on originator (n = 71) (50 vs 87 weeks; hazard ratio = 2.42; P = .0003).
LIMITATIONS: Limitations include its retrospective design and variable biosimilar formulations.
CONCLUSION
Significant differences in clinical response, loss of response, and time-to-event analysis between originator and biosimilar adalimumab in HS underscore the need for consistent treatment and robust monitoring to optimize management.
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