Switching from adalimumab originator to biosimilars in hidradenitis suppurativa: What's beyond cost‐effectiveness?

Abstract

In the last years, adalimumab biosimilars have represented a commonly used alternative to the originator agent in the treatment of moderate to severe hidradenitis suppurativa. As of today, studies investigating the switch from adalimumab originator to biosimilar, following pharmacoeconomic policies, are lacking. Herein we present a real-life setting retrospective study aimed at assessing the safety and efficacy of this switch in 37 patients, evaluated for 12 months in terms of IHS4 (International Hidradenitis Suppurativa Severity Score System) and HiSCR (Hidradenitis Suppurativa Clinical Response). Overall, no significant differences emerge between adalimumab originator and biosimilar in terms of clinical response following non-medical switch.High discontinuation rates (43.2%) raise questions on patients' compliance to the new drug regimen, as severe pain at the injection site represents a substantial cause of biosimilar discontinuation (i.e., 31.5% of the cases). In selected cases, rechallenge with adalimumab originator may represent a valid option, as 66.6% (n = 8) of the patients who switched back to the former agent have benefited in terms of tolerability and efficacy. Carefully integrating pharmacoeconomic policies with a thorough assessment regarding the benefit-risk ratio of a nonmedical switch from originator to biosimilars remains essential to provide each HS patient with the best therapeutic option.

S2k-Leitlinie zur Therapie der Hidradenitis suppurativa/Acne inversa (ICD-10-Code: L73.2)

“…Eine weitere retrospektive Studie mit 37 Patienten untersuchte die Sicherheit und Wirksamkeit der Umstellung unter realen Bedingungen über 12 Monate anhand des IHS4 und des HiSCR 403 . Insgesamt zeigten sich keine signifikanten Unterschiede zwischen dem Originalpräparat von Adalimumab und dem Biosimilar in Bezug auf das klinische Ansprechen.…”

Adalimumab, Ustekinumab, and Secukinumab in the Management of Hidradenitis Suppurativa: A Review of the Real-Life Experience

“…Roccuzzo et al 31 recently presented a retrospective real-world study designed to evaluate the safety and efficacy of switching from adalimumab originator to biosimilars in 37 patients, evaluated for 12 months in terms of IHS4 (International Hidradenitis Suppurativa Severity Score System) and HiSCR. Overall, no significant differences emerged between originator and biosimilar adalimumab in terms of clinical response following nonmedical switch.…”

“…Overall, no significant differences emerged between originator and biosimilar adalimumab in terms of clinical response following nonmedical switch. 31 …”

Current Medical and Surgical Treatment of Hidradenitis Suppurativa—A Comprehensive Review

“…Several studies have demonstrated the bioequivalence and similar safety profiles of the adalimumab biosimilars compared to the originator agent [ 122 , 123 ]. However, a loss of treatment efficacy has been observed after switching from adalimumab originator to biosimilars in clinical studies [ 124 , 125 , 126 ]. Kirsten et al evaluated the clinical responses of 94 patients after switching from adalimumab originator to biosimilar ABP 501, and reported a loss of response or new onset of adverse events in 33.3% [ 127 ].…”