TNF-α inhibitors biosimilars as first line systemic treatment for moderate-to-severe chronic plaque psoriasis

Gisondi, Paolo; Geat, Davide; Conti, Andrea; Dapavo, Paolo; Piaserico, Stefano; Simone, Clara De; Bianchi, Luca; Costanzo, Antonio; Malagoli, Piergiorgio; Malara, Giovanna; Micali, Giuseppe; Naldi, Luigi; Offidani, Annamaria; Patrizi, Annalisa; Prignano, Francesca; Parodi, Aurora; Rongioletti, Franco; Calzavara‐Pinton, Piergiacomo; Girolomoni, Giampiero

doi:10.1080/1744666x.2020.1771182

Cited by 24 publications

(11 citation statements)

References 51 publications

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“…Furthermore, adalimumab originator was considered for the model because it was the one tested in the EXCEED study. However, adalimumab biosimilars are available and have shown a comparable efficacy to the originator, while their cost is significantly lower than that of the originator [ 38 , 39 , 40 ]. Another limitation of the study is that we included in this analysis only drug acquisition costs without considering the costs of the visits and laboratory screening/monitoring.…”

Section: Discussionmentioning

confidence: 99%

Cost per Responder Analysis of Secukinumab versus Adalimumab in the Treatment of Psoriatic Disease

et al. 2022

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Background: The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab in psoriatic arthritis, but it did not include a pharmacoeconomic analysis. The objective of this study was to compare the cost per responder of secukinumab versus adalimumab in patients with psoriatic disease. Methods: The cost per responder was calculated by multiplying the cost of treatment by the number needed to treat for each therapy. The 52-week primary endpoint was the American College of Rheumatology response rate (ACR) 20; secondary endpoints were ACR 50, Psoriasis Area and Severity Index (PASI) 90, and minimal disease activity (MDA). Results: The cost per responder for ACR 20 was €19,846 versus €19,766 for secukinumab and adalimumab, respectively, whereas the costs per responder for ACR 50 and PASI 90 were €27,820 versus €27,384 and €22,102 versus €32,375 for secukinumab and adalimumab, respectively. The cost per MDA responder was €34,072 and €38,906 for secukinumab versus adalimumab. Conclusions: The costs per responder associated with the psoriatic arthritis end points were similar for adalimumab and secukinumab; conversely, the costs for psoriasis and composite end points were lower for secukinumab.

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Section: Discussionmentioning

confidence: 99%

Cost per Responder Analysis of Secukinumab versus Adalimumab in the Treatment of Psoriatic Disease

et al. 2022

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“…Moreover, whether early intervention with biologics, including adalimumab, could impact on the psoriasis course in terms of prevention of PsA and/or cumulative life course impairment (CLCI) is currently under investigation [ 25 – 29 ]. Two recent studies by Acosta Felquer et al.…”

Section: Discussionmentioning

confidence: 99%

Real-Life Effectiveness of Adalimumab Biosimilars in Patients with Chronic Plaque Psoriasis

Bellinato

Gisondi

Mason

et al. 2022

Dermatol Ther (Heidelb)

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Introduction The real-life effectiveness of adalimumab biosimilars in patients with psoriasis has rarely been investigated. Objective To investigate drug survival of adalimumab biosimilars in patients with chronic plaque psoriasis and factors associated with its discontinuation. Methods We carried out a retrospective observational study including all consecutive patients with chronic plaque psoriasis who initiated adalimumab biosimilar MSB11022 (Idacio), ABP501 (Amgevita), or SB5 (Imraldi) between 1 January 2018 and 1 January 2021. The 1-year drug survival of adalimumab biosimilar and independent factors associated with its discontinuation were investigated. Cox regression models were fit to estimate adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) for the risk of adalimumab discontinuation. A propensity score matching (PSM) model was adopted as sensitivity analysis. Results The study involved a total of 410 patients with follow-up of 549.84 person-years, 271 (66.1%) men, a mean (SD) age of 51.8 (14.5) years, and a baseline PASI of 14.54 (5.02). Among adalimumab biosimilars, 250 (61%) patients received MSB11022, 98 (24%) received ABP501, and 62 (15%) received SB5. Drug survival of adalimumab biosimilars at 1 year was 81.5% in the overall study population. Obesity was associated with increased risk of adalimumab discontinuation (HR = 2.01; 95% CI 1.33–3.03), whereas psoriatic arthritis (aHR = 0.32; 95% CI 0.16–0.64) and receiving adalimumab as first systemic treatment (aHR = 0.44; 95% CI 0.27–0.70) were associated with lower risk. Conclusion The real-life effectiveness of adalimumab biosimilars in patients with psoriasis is consistent with that previously reported for the originator. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-022-00732-y.

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“… 37 In the recent years, different anti-TNF-α biosimilars allowed the dermatologist to prescribe effective biologics at a very competitive cost. 38 , 39 Biosimilars are medications very similar to the originator approved biologic without clinically significative safety, purity, and potency differences and different only in terms of the manufacturing process, excipient and delivery device used. The biosimilars are tested versus originators through double-blind crossover design trials assessing pharmacokinetics, immunogenicity and drug safety.…”

Section: Discussionmentioning

confidence: 99%

Latest Advances for the Treatment of Chronic Plaque Psoriasis with Biologics and Oral Small Molecules

Bellinato

Gisondi

Girolomoni

2021

BTT

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Psoriasis is a common immune-mediated chronic skin disease. Disease severity is influenced by several factors including the extent and localization of skin lesions, severity of pruritus and comorbidities, such as psoriatic arthritis. Moderate to severe psoriasis is defined when cutaneous involvement is diffuse, covering more than 10% of the body surface areas and/or involving the sensitive areas such as face, genitalia, folds or nails or has high impact on patients’ quality of life, and it occurs in approximately 15% of cases. In recent years, a growing understanding of psoriasis pathophysiology allowed the development of an increasing number of effective and safe treatments, including biologicals that are indicated for moderate to severe psoriasis. Different classes of biologicals have been already approved, including TNF-α (etanercept, infliximab, adalimumab and certolizumab pegol), IL-12/23 (ustekinumab), IL-17 (secukinumab, ixekizumab, brodalumab) and IL-23 (guselkumab, risankizumab, tildrakizumab) inhibitors. The objective of this narrative review is to revise efficacy and safety data of the latest biologicals, small oral molecules and biosimilar drugs for the treatment of chronic plaque psoriasis at Phase III of clinical development. The latest IL-17 and IL-23 inhibitors include bimekizumab, netakimab and mirikizumab as well as oral small molecules, such as deucravacitinib, a tyrosine kinase 2 selective inhibitor, and piclidenoson, an agonist of the Gi protein-associated A3 adenosine receptor. Additional molecules are in an early phase of development. Highly promising biologicals and small oral molecules are the leading edge of the systemic treatment of psoriasis.

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TNF-α inhibitors biosimilars as first line systemic treatment for moderate-to-severe chronic plaque psoriasis

Cited by 24 publications

References 51 publications

Cost per Responder Analysis of Secukinumab versus Adalimumab in the Treatment of Psoriatic Disease

Cost per Responder Analysis of Secukinumab versus Adalimumab in the Treatment of Psoriatic Disease

Real-Life Effectiveness of Adalimumab Biosimilars in Patients with Chronic Plaque Psoriasis

Latest Advances for the Treatment of Chronic Plaque Psoriasis with Biologics and Oral Small Molecules

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