Clinical experience with adalimumab biosimilar imraldi in hidradenitis suppurativa

Ricceri, Federica; Rosi, Elia; Cesare, Antonella Di; Pescitelli, Leonardo; Fastame, Maria Thais; Prignano, Francesca

doi:10.1111/dth.14387

Cited by 17 publications

(15 citation statements)

References 5 publications

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“…Ricceri et al evaluated seven HS patients switching adalimumab originator to biosimilar SB5 adalimumab and found similar effectiveness rates compared to naïve HS patients treated with this biosimilar. Nevertheless, tolerability was not evaluated in this report [23]. Patil also reported effectiveness in two HS patients being treated with biosimilar ZRC-3197 adalimumab.…”

Section: Discussionmentioning

confidence: 88%

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

Montero‐Vílchez

Cuenca‐Barrales

Rodriguez-Tejero

et al. 2022

JCM

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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.

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Section: Discussionmentioning

confidence: 88%

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

Montero‐Vílchez

Cuenca‐Barrales

Rodriguez-Tejero

et al. 2022

JCM

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“…At the same time, 6 patients (35.3%) experienced side effects such as pain at the injection site, dizziness and nausea [ 17 ]. One clinical trial observed similar effectiveness and tolerability between originator adalimumab and biosimilar SB5 in 11 patients [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response—Data from the German HS Registry HSBest

Kirsten

Ohm

Gehrdau

et al. 2022

Life

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Since 2021, adalimumab biosimilar ABP 501 can be used alternatively to adalimumab originator (ADAO) in the treatment of hidradenitis suppurativa (HS). Effectiveness and safety data remain scarce. We investigated the impact of switching from ADAO to ABP 501 on disease severity and the occurrence of adverse events (AEs) in patients with HS. We analyzed clinical data on patients enrolled in the German HSBest registry. Evaluation outcomes were assessed at three time points (baseline of originator (t0), prior to switching to biosimilar (t1) and 12 to 14 weeks after switching (t2)) and included patient-reported AEs and disease severity using the International Hidradenitis Suppurativa Severity Score System (IHS4) score. In total, 94 patients were switched from ADAO to ABP 501. Overall, 33.3% (n = 31/94) of the patients developed AEs and/or loss of response (LoR) within 12 to 14 weeks after switching. Of these, 61.3% (n = 19/31) experienced LoR but no AEs, 22.6% (n = 7/31) LoR combined with AEs and 16.1% (n = 5/31) AEs only. Our study showed that switching HS patients from ADAO to ABP 501 does significantly affect treatment effectiveness. Switching patients who are on remission maintenance therapy should be viewed critically.

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“…Biosimilar ADA (SB5) has also been found to be effective, well tolerated, and interchangeable with originator ADA for HS treatment in a retrospective 36 weeks ‘real life’ observational study. 124…”

Section: Treatmentmentioning

confidence: 99%

“…123 Biosimilar ADA (SB5) has also been found to be effective, well tolerated, and interchangeable with originator ADA for HS treatment in a retrospective 36 weeks 'real life' observational study. 124 Calprotectin, fractalkine, and HCC-4 have been identified as potential predictive biomarkers of ADA response (86% predictive accuracy rate for ADA response). 125 The superior response to TNF-α blockade of subcutaneous nodules versus tunnels suggests that the formation of the latter is mediated by IL-17 rather than by TNF-α signaling.…”

Section: Surgerymentioning

confidence: 99%

New perspectives on the treatment of hidradenitis suppurativa

Amat-Samaranch

Agut-Busquet

Vilarrasa

et al. 2021

Therapeutic Advances in Chronic Disease

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Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by the presence of painful nodules, abscesses, chronically draining fistulas, and scarring in apocrine gland-bearing areas of the body. The exact pathogenesis of HS is not yet well understood, but there is a consensus in considering HS a multifactorial disease with a genetic predisposition, an inflammatory dysregulation, and an influence of environmental modifying factors. Therapeutic approach of HS is challenging due to the wide clinical manifestations of the disease and the complex pathogenesis. This review describes evidence for effectiveness of current and emerging HS therapies. Topical therapy, systemic treatments, biological agents, surgery, and light therapy have been used for HS with variable results. Adalimumab is the only US Food and Drug Administration (FDA) approved biologic agent for moderate-to-severe HS, but new therapeutic options are being studied, targeting different specific cytokines involved in HS pathogenesis. Comparing treatment outcomes between therapies is difficult due to the lack of randomized controlled trials. Treatment strategy should be selected in concordance to disease severity and requires combination of treatments in most cases.

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Clinical experience with adalimumab biosimilar imraldi in hidradenitis suppurativa

Cited by 17 publications

References 5 publications

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

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

Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response—Data from the German HS Registry HSBest

New perspectives on the treatment of hidradenitis suppurativa

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