Switching from Adalimumab Originator to Biosimilar: Clinical Experience in Patients with Hidradenitis Suppurativa.

Trinidad Montero-Vilchez,Andrea Rodriguez-Tejero,Carlos Cuenca-Barrales,Salvador Arias-Santiago,Alejandro Molina-Leyva,Antonio Martinez-Lopez

doi:10.3390/jcm11041007

Abstract

Adalimumab is currently the only biological medicine approved by the FDA for the treatment of hidradenitis suppurativa (HS). The breakout of biosimilar drugs made them more accessible due to their impact on pharmacoeconomics. However, packaging, formulation, or excipients are unique characteristics of each drug. In that way, switching from adalimumab originator to biosimilar and between biosimilars could have implications in the clinical practice. The objective of this study is to describe our clinical experience in switching from adalimumab originator to biosimilar and switching back again. A single-center retrospective cohort study was conducted that included seventeen patients with HS treated with adalimumab originator in the maintenance phase, and that achieved Hidradenitis Suppurativa Clinical Response (HiSCR), who were switched to adalimumab biosimilar for no medical reasons. The reason for the change was to improve pharmacoeconomic efficiency, following our hospital policies on biologics. Median duration with adalimumab originator treatment before switching was 48 weeks. After switching, 41.2% of patients maintained HiSCR response without additional issues, while 58.8% (10/17) reported problems after the change. Switching from adalimumab originator to biosimilar in well-controlled patients could imply problems in efficacy and adherence. Switching back to adalimumab originator appears to solve most of the problems, but some patients can lose confidence in the drug and discontinue it. It would be worthwhile to evaluate the benefit–risk ratio individually when switching an HS patient to adalimumab biosimilar.

Highlights

Introduction published maps and institutional affilHidradenitis suppurativa (HS) is a recurrent, chronic, debilitating, inflammatory skin disease of the hair follicle that typically presents after puberty with deep-seated, painful, inflamed lesions in the apocrine gland-bearing areas of the body, most commonly the inguinal, axillae, and anogenital regions [1]
Biologics have revolutionized the treatment of these diseases, but they are expensive drugs reserved for severe refractory patients [4]
It included all adult patients diagnosed with hidradenitis suppurativa (HS), on treatment with adalimumab originator, who were switched for non-medical reasons to adalimumab biosimilar in our HS clinic

Summary

Introduction

Hidradenitis suppurativa (HS) is a recurrent, chronic, debilitating, inflammatory skin disease of the hair follicle that typically presents after puberty with deep-seated, painful, inflamed lesions in the apocrine gland-bearing areas of the body, most commonly the inguinal, axillae, and anogenital regions [1]. Adalimumab, a monoclonal antibody against tumor necrosis factor-α, is the only biologic agent currently available for treating moderate to severe HS approved by the FDA [2]. Adalimumab is employed in other autoimmune diseases, such as psoriasis, rheumatoid arthritis, or inflammatory bowel disease [3]. Biologics have revolutionized the treatment of these diseases, but they are expensive drugs reserved for severe refractory patients [4]. The breakout of biosimilar drugs, as they reach patent expiry, made biological drugs more available due to their impact on pharmacoeconomics, decreasing their impact on health care budgets [5,6].

Objectives

Methods

Results

Discussion

Conclusion