<scp>SB5</scp>
            adalimumab biosimilar in the treatment of psoriasis and psoriatic arthritis

Cesare, Antonella Di; Tronconi, Greta; Fastame, Thais M.; Rosi, Elia; Pescitelli, Leonardo; Ricceri, Federica; Prignano, Francesca

doi:10.1111/dth.13435

Cited by 13 publications

(14 citation statements)

References 7 publications

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“…PsA patients showed a significant increase in patientreported outcomes (PtGA, VAS pain and HAQ), in the DAPSA and also presented with a slight non-statistically significant increase in NSAIDs or CCS intake at 3 months. As seen for RA patients, these changes in the concomitant medications allowed the control of disease activity, with 6 months [19]. Moreover, we also presented data of clinician-reported outcomes, peripheral and overall disease activities, proving further data on real-life switching from ADA to SB5 in PsA.…”

Section: Discussionsupporting

confidence: 59%

“…A small cohort of real-life PsA patients was recently published, showing signs of axial disease flare in 3/12 patients after switching from ADA to SB5, leading to change in concomitant medication in 2 cases and back-switch to ADA originator in the third [19]. With the exclusion of this report, no other data on ADA/SB5 switching are available for non-RA patients affected by other inflammatory RMDs.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

et al. 2020

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Objective SB5 showed comparable efficacy and safety profile in respect to adalimumab originator (ADA) in randomized clinical trials of rheumatoid arthritis (RA) and psoriasis. We aimed to describe the efficacy and safety of SB5 after switching from ADA in RA, axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and juvenile idiopathic arthritis (JIA) patients. Method Adult RA, PsA, axSpA, JIA patients treated with ADA for at least 6 months, switched to SB5 in stable clinical conditions, were eligible. Data on safety, activity indexes and patient-reported outcomes were collected at baseline, 3 and 6 months after switching. Results Eighty-two patients (19 RA, 28 PsA, 32 axSpA and 3 JIA; 45 females, mean age 54 ± 14 years, disease duration 13 ± 7 years, ADA duration 6 ± 3 years) were enrolled. RA patients showed stable conditions, while PsA patients showed an increase in both HAQ, DAS28(CRP) and DAPSA and axSpA patients an increase in VAS pain, VAS patient disease activity and ASDAS, both at 3 months. There were changes in the concomitant medications profile, with regression of activity indexes increases at 6 months. Adverse events were reported by 33.7% patients at 3 months and 16.6% patients at 6 months, mostly disease flares and infectious events. Two patients stopped SB5. Conclusions Despite temporary changes in the concomitant medication profile for mild disease flares, our real-life data replicate the safety profile of switching from ADA to SB5 in RA, with additional data for its applicability in PsA and axSpA patients, further supporting switching to biosimilars in treating inflammatory rheumatic conditions. Key Points• Switching from adalimumab originator to SB5 is feasible in real life rheumatic inflammatory joint diseases.• Mild disease flares can present after switching from originator adalimumab to SB5, in particular in axial spondyloarthritis and psoriatic arthritis.• Changes in concomitant medications profile allows the control of minor disease flares presenting after switching from adalimumab originator to SB5.

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Section: Discussionsupporting

confidence: 59%

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

et al. 2020

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“…The greater potency of these new drugs as compared to the traditional systemic agents for example, methotrexate, acitretin and cyclosporine, etc. highlights the significance of IL‐23 in the amplification of the immune response and has supported the role of Th17 cell type as the most dominant T cell subset in psoriasis 17‐21 …”

Section: Introductionmentioning

confidence: 89%

“…highlights the significance of IL-23 in the amplification of the immune response and has supported the role of Th17 cell type as the most dominant T cell subset in psoriasis. [17][18][19][20][21] Naive T-cells upon activation transform into Th1, Th2, Th17, and T regulatory cells. Each of these subsets in turn produces certain cytokines and lymphokines like Interferon-gamma (IFN-γ), TNF-α, and TNF-β.…”

mentioning

confidence: 99%

Interleukin 23p19 inhibitors in chronic plaque psoriasis with focus on mirikizumab: A narrative review

Salimi

Yamauchi

Thakur

et al. 2020

Dermatologic Therapy

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Psoriasis, a T‐cell mediated chronic dermatosis, has a complex etiopathogenesis. There has been extensive research into the aberrant immune response, which leads to the formation of clinical lesions, and the need for developing better and safer drugs has been unrelenting. The past two decades of research has opened up new areas of the immune pathway that can be targeted in order to control the disease. Therefore, we have seen the emergence of biologics which either target T‐cell receptors or inhibit Tumor Necrosis Factor‐alpha (TNF‐α) or inhibit interleukins (IL) like IL‐12, IL‐17, IL‐17 receptor, and more recently IL‐23. Drugs specifically targeting the p19 subunit of IL‐23 have shown promising results in the management of chronic plaque psoriasis. This has given way to the development of a new class of biologics, that is, the IL‐23p19 inhibitors that have a better safety profile as compared to its predecessors. In this review, we shall scrutinize the role of IL‐23 and Th17 cell signaling in the evolution of the psoriatic lesions and summarize the clinical experience with IL‐23p19 inhibitors especially mirikizumab in the treatment of chronic plaque psoriasis.

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“…Safety data from real-world practice are available only for SB5. Di Cesare et al 46 reported a small cohort study of real-life PsO/PsA patients switching from reference adalimumab to SB5. Of 20 switched patients, two experienced loss of efficacy on cutaneous symptoms, with one case leading to SB5 discontinuation and switching to an IL-12/23 antagonist and the other case developing pustular psoriasis.…”

Section: Interchangeability With Reference Adalimumabmentioning

confidence: 99%

An Update Review of Biosimilars of Adalimumab in Psoriasis – Bioequivalence and Interchangeability

Xin¹,

Chen²,

Bi³

2021

DDDT

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Biologic drugs have revolutionized the treatment of psoriasis and other rheumatological diseases. In recent years, many biosimilar agents that are highly similar in structure and function to their originator products have been developed, including the tumor necrosis factor-alpha antagonist adalimumab. The considerably lower cost of these products has greatly cut the economic burden of the patients and increased the accessibility of biologic therapies worldwide. The US Food and Drug Administration and/or the European Medicines Agency have approved eight biosimilars of adalimumab (ABP 501/BI 695501/SB5/GP2017/ FKB327/MSB11022/PF-06410293/CT-P17) for the treatment of psoriasis, and others are under review. Given that these agents showed pharmacokinetic, efficacy, safety, and immunogenicity profiles comparable to those of the originator, adalimumab biosimilars were licensed for all indications approved for reference adalimumab based on extrapolation; however, some of the equivalence studies were only conducted in one or two disease populations. This review discusses the bioequivalence of adalimumab biosimilars as demonstrated by various clinical trials, the extrapolation of indications, guidance and policies of the EU and US on interchangeability (nonmedical switching/automatic substitution) between biosimilars and originators, and the real-life practices of switching from reference adalimumab to the respective biosimilars. Further data from real-world studies and post-marketing analyses are needed better to address the efficacy and safety of the transition strategy.

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SB5 adalimumab biosimilar in the treatment of psoriasis and psoriatic arthritis

Cited by 13 publications

References 7 publications

Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

Interleukin 23p19 inhibitors in chronic plaque psoriasis with focus on mirikizumab: A narrative review

An Update Review of Biosimilars of Adalimumab in Psoriasis – Bioequivalence and Interchangeability

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