Infliximab biosimilar CT-P13 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry

Gisondi, Paolo; Bianchi, Luca; Conti, Andrea; Dapavo, Paolo; Malagoli, Piergiorgio; Piaserico, Stefano; Savoia, Francesca; Prignano, Francesca; Girolomoni, Giampiero

doi:10.1111/bjd.15659

Cited by 20 publications

(16 citation statements)

References 6 publications

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“…There was no significant difference in the number of adverse events between switch patients and etanercept-naive patients. Similar observations from the PsoBiosimilars Registry have been reported for the infliximab biosimilar CT-P13 (47).…”

Section: National Registry Datasupporting

confidence: 82%

“…Longer-term safety and efficacy monitoring of large populations is necessary and ongoing (44,45). Limited realworld data are also available for the infliximab biosimilar CT-P13 in patients with psoriasis (2,46,47). Adalimumab biosimilars have only very recently entered the European market (20), so there is no substantial real-world data with any of these drugs.…”

Section: Biosimilars In Daily Practicereal-world Evidencementioning

confidence: 99%

“…The PsoBiosimilars Registry is an Italian registry of anti-TNF biosimilars in psoriasis and PsA (45,47). As of July 2018, 39 centers had registered a total of 197 patients treated with SB4 (158 patients switched from reference etanercept and 39 etanercept-naive patients).…”

Section: National Registry Datamentioning

confidence: 99%

“…Although there may be concerns that the majority of pivotal trials with anti-TNF biosimilars have not been conducted in patients with psoriasis (1,9), the European biosimilar development and approval process, based on the totality of the evidence and appropriate scientific justification (6), means that if an anti-TNF biosimilar drug is shown to be effective in rheumatoid arthritis it is also likely to be effective in psoriasis. National registry data for the etanercept biosimilar SB4 and the infliximab biosimilar CT-P13 support this assertion (44,45,47). Although there are currently no real-world data for adalimumab biosimilars in patients with psoriasis, robust, randomized, double-blind, switching evidence for these drugs comes from phase III studies of ABP 501 and GP2017 in patients with psoriasis (54,56), and BI 695501 and SB5 in patients with rheumatoid arthritis (49,53).…”

Section: Clinical Trial Switching Datamentioning

confidence: 99%

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Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

Barker

Girolomoni

Egeberg

et al. 2019

Journal of Dermatological Treatment

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Tumor necrosis factor (TNF) inhibitors account for a large proportion of drugs used to treat psoriasis and are indicated first-line options in certain settings. Several biosimilar drugs based on the anti-TNF agents adalimumab, infliximab, and etanercept are now available for use in patients with psoriasis. The favorable cost differential of biosimilars is expected to improve access to biologic therapy for biologic-naive psoriasis patients, who are often undertreated. Also, substantial cost savings can be made if patients are switched to biosimilars. To date, most clinical testing of anti-TNF biosimilars approved for use in psoriasis has been performed in patients with rheumatoid arthritis, and the results extrapolated to psoriasis. Although this may initially raise concerns for clinicians looking to start their psoriasis patients on biologic treatment with a biosimilar or switch from an original biologic to a biosimilar, the process of extrapolation is tightly regulated and scientifically justified. Furthermore, available real-world evidence of the safety and efficacy of anti-TNF agents in patients with psoriasis complements clinical trial data in patients with rheumatoid arthritis. When equipped with the appropriate knowledge, clinicians should have confidence to use biosimilars for the treatment of psoriasis.

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Section: National Registry Datasupporting

confidence: 82%

Section: Biosimilars In Daily Practicereal-world Evidencementioning

confidence: 99%

Section: National Registry Datamentioning

confidence: 99%

Section: Clinical Trial Switching Datamentioning

confidence: 99%

See 2 more Smart Citations

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

Barker

Girolomoni

Egeberg

et al. 2019

Journal of Dermatological Treatment

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“…In our case, we observed a clinical improvement in a patient treated with gastric bandage, with maintenance of efficacy of infliximab after switch from originator to biosimilar, as reported by registries data (Gisondi et al, ). A multidisciplinary approach is recommended in obese patients; further studies are required about the bariatric surgery in psoriatic patients, in particular about gastric bandage.…”

Section: Discussionsupporting

confidence: 83%

Psoriasis improvement after gastric bandage in a patient partial responder to infliximab

Odorici

Conti

2017

Dermatologic Therapy

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Patients overweight or obese have more severe psoriasis than normal weight patients. Sometimes the excessive weight is related to a lack of efficacy of systemic treatment. We report a case of a psoriatic patient that experienced a dramatic improvement of psoriasis after weight loss surgery by gastric bandage. The great weight loss was accompanied by an effectiveness gain of response to infliximab. The mechanism responsible for this association is not certain, but it is probably multifactorial, involving genetic, environmental and immune-mediated factors. It has been suggested that adipose tissue can dramatically alter the volume of drug distribution and limit drug efficacy. Moreover, a reduction of weight could favour the response to therapy and remission of the disease, inducing an improvement in patient's quality of life. Gastric bandage has a scarce rate of complications, a fast recovery and scarce life-threatening complications. It should be considered in obese patient that not shown effectiveness to therapy.

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Increasing Access to Effective Systemic Treatments in Patients with Moderate-to-Severe Psoriasis: Narrative Review

Girolomoni,

Savage,

Gisondi

et al. 2023

Dermatol Ther (Heidelb)

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Psoriasis is a chronic, immune-mediated inflammatory disease with a worldwide prevalence ranging between 0.51 and 11.43%. It results in a large clinical and social burden, with patients frequently suffering from reduced quality of life, psychologic distress and debilitating comorbidities. Biologic agents are used to establish and maintain disease control in patients with moderate-to-severe psoriasis and are essential to improving quality of life. However, a substantial proportion of patients have limited access to therapy due to economics, health policies and clinical considerations, which creates clinical unmet needs that disadvantage both patients and healthcare professionals. Biosimilars are a cost-effective alternative to off-patent biologic therapies, and there is mounting evidence to suggest they offer a valuable pharmacoeconomic strategy to lower healthcare costs in patients with psoriasis. Furthermore, the introduction of biosimilars can increase the number of patients able to receive biologics, allowing these patients to be treated earlier in the disease course, potentially modifying the course of their disease and reducing the risk of comorbidities. In time, the emergence of additional data, particularly those related to long-term safety, efficacy in extrapolated indications and the effects of switching, should reassure physicians and help overcome the final hurdles for a wider implementation of biosimilars. This review aims to provide an overview of current treatment approaches for patients with moderate-to-severe psoriasis in the biosimilars era and explores both the current challenges and potential opportunities to improve access to high-quality, effective treatments.

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Infliximab biosimilar CT-P13 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry

Cited by 20 publications

References 6 publications

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

Psoriasis improvement after gastric bandage in a patient partial responder to infliximab

Increasing Access to Effective Systemic Treatments in Patients with Moderate-to-Severe Psoriasis: Narrative Review

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