Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches

Blauvelt, Andrew; Lacour, Jean‐Philippe; Fowler, Joseph F.; Weinberg, Jeffrey M; Gospodinov, Dimitar; Schuck, Ellen; Jauch-Lembach, Julia; Balfour, Alison; Leonardi, Craig L.

doi:10.1111/bjd.16890

Cited by 120 publications

(135 citation statements)

References 23 publications

(69 reference statements)

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“…Patients who switched from reference adalimumab to MSB11022 at week 16 showed similarity in all efficacy, safety and immunogenicity end points assessed compared with patients who continued on MSB11022 or reference product throughout the trial. This is consistent with several previous studies that have shown no impact of switching, including multiple switches, from a TNF inhibitor reference product to a biosimilar and vice versa in inflammatory disease …”

Section: Discussionsupporting

confidence: 93%

“…This is consistent with several previous studies that have shown no impact of switching, including multiple switches, from a TNF inhibitor reference product to a biosimilar and vice versa in inflammatory disease. [44][45][46][47] The present study and analysis of switching data have some limitations. Most importantly, as its primary objective was to assess biosimilarity, the study was not powered for statistical comparisons of equivalence after switching.…”

Section: Discussionmentioning

confidence: 87%

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AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

Hercogová

Papp

Chyrok³

et al. 2019

Br J Dermatol

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Summary Background MSB11022 is a proposed adalimumab biosimilar. Objectives To compare the efficacy, safety and immunogenicity of MSB11022 with reference adalimumab. Methods AURIEL‐PsO was a double‐blind randomized controlled equivalence trial, in which patients with moderate‐to‐severe chronic plaque‐type psoriasis were randomized 1 : 1 to MSB11022 or reference adalimumab. The primary end point was ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 16, with a prespecified equivalence interval of ± 18%. Patients with a ≥50% improvement in PASI at week 16 were eligible to enter a double‐blind extension period: patients receiving MSB11022 continued treatment, and patients receiving reference adalimumab were rerandomized 1 : 1 either to continue reference adalimumab or to switch to MSB11022. Other efficacy end points and safety, immunogenicity and pharmacokinetic parameters were evaluated at scheduled visits up to weeks 52 (efficacy and immunogenicity), 54 and 66 (safety). Results In total, 443 patients were randomized. The difference in PASI 75 response rates at week 16 between the treatment arms was −1·9%, and the 95% confidence interval (−7·8% to 4·1%) was within the prespecified equivalence interval. No notable difference in the incidence of treatment‐emergent adverse events was observed between treatment arms up to the end of the trial, and no new safety signals were observed. Following treatment switch at week 16, no clinically meaningful differences in safety or immunogenicity were seen between treatment arms through to the end of the observation period. Conclusions Therapeutic equivalence between MSB11022 and reference adalimumab was demonstrated. AURIEL‐PsO provides evidence to support the similarity of both products with regard to efficacy, safety and immunogenicity. What's already known about this topic? Adalimumab is a fully human antitumour necrosis factor‐α monoclonal antibody, indicated for the treatment of multiple inflammatory disorders, including psoriasis, psoriatic arthritis, rheumatoid arthritis, inflammatory bowel diseases and ankylosing spondylitis. MSB11022 is a proposed adalimumab biosimilar that has shown structural and functional similarity to the reference product in an extensive analytical comparability exercise. MSB11022 has demonstrated bioequivalence and comparable safety and immunogenicity profiles in a phase I study in healthy volunteers. What does this study add? This phase III study confirmed equivalent efficacy for MSB11022 and reference adalimumab in patients without any immunomodulation comedication in moderate‐to‐severe chronic plaque‐type psoriasis at week 16. The efficacy, safety and immunogenicity of MSB11022 and reference adalimumab were similar over the respective observation periods (week 52 for efficacy and immunogenicity, week 66 for safety). A switch from reference adalimumab to MSB11022 at week 16 did not impact efficacy, safety or immunogenicity.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 87%

AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

Hercogová

Papp

Chyrok³

et al. 2019

Br J Dermatol

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“…Data regarding single switches are accumulating, but, to our knowledge, no published studies have investigated cross-switching (between two biosimilars) or multiple/ repeated switches in RA or IBD [159,163,164] with regard to efficacy, safety, or cost considerations. However, evidence regarding multiple switching is emerging in psoriasis, with no impact on efficacy, safety, or immunogenicity detected after up to four switches between reference adalimumab and GP2017 [165] or up to three switches between reference etanercept and GP2015 [166]. Nevertheless, future studies should cautiously assess multiple and cross-switches in patients with other IMIDs; the pharmacoeconomic implications remain to be determined.…”

Section: Pharmacoeconomists' Perspective: Cost Of and Access To Biolomentioning

confidence: 99%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

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Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

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“…[12,13]. Beginnend mit der randomisierten und kontrollierten NOR-SWITCH-Studie [6] konnte für CED in mehreren Studien [14,15] [21].…”

Section: Biosimilars In Gastroenterology a Position Statement Of Theunclassified

Biosimilars in der Gastroenterologie

Dejaco

Novacek

Haas³

et al. 2020

J. Gastroenterol. Hepatol. Erkr.

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Zusammenfassung Biologika nehmen eine herausragende Rolle in der Therapie chronisch-entzündlicher Darmerkrankungen (CED) ein. Diese aus lebenden Zellen biotechnologisch hergestellten Antikörper (Ak) ermöglichen zunehmend selektive antientzündliche Behandlungsansätze, wobei deren Produktion und Zulassung einem komplexen und kostenintensiven Entwicklungsprozess unterliegen. Mit Patentablauf einzelner Biologika kommen seit einigen Jahren nun zunehmend Biosimilars, ebenso biotechnologisch produzierte Nachfolgepräparate, auf den Markt und führen zu einer zunehmenden Präparatevielfalt bei sinkenden Kosten für das Gesundheitssystems. Das vorliegende Positionspapier der Arbeitsgruppe (AG) CED der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie (ÖGGH) versucht mit dieser Entwicklung aufkommende Fragen betreffend Wirksamkeit, Sicherheit, Präparatewechsel (Switch) und Verschreibungsgebarung zu beantworten, um eine höchstmögliche Patientensicherheit auch zukünftig zu gewährleisten.

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Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches

Abstract: Following the demonstration of GP2017 biosimilarity to ref-ADMB, switching up to four times between GP2017 and ref-ADMB had no detectable impact on efficacy, safety or immunogenicity.

Cited by 120 publications

References 23 publications

AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Biosimilars in der Gastroenterologie

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