Effectiveness of non-medical switch from adalimumab bio-originator to SB5 biosimilar and from ABP501 adalimumab biosimilar to SB5 biosimilar in patients with chronic inflammatory arthropathies: a monocentric observational study

Castellani, Chiara; Mancuso, Silvia; Sciarra, Giorgio; Giardina, Federico; Bevignani, Giulia; Ceccarelli, Fulvia; Spinelli, Francesca Romana; Alessandri, Cristiano; Franco, Manuela Di; Riccieri, Valeria; Priori, Roberta; Conti, Fabrizio

doi:10.55563/clinexprheumatol/bf00j9

Cited by 4 publications

(4 citation statements)

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“…A single-center study compared the effectiveness of switching from adalimumab biosimilar ABP501 to adalimumab biosimilar SB5 in 40 patients with chronic inflammatory arthritis (RA, n = 12 [30%]; PsA, n = 25 [62%]; AxSpA, n = 3 [8%]) [ 17 ]. After 4 months of SB5 treatment, no differences were seen in 28-joint Disease Activity Score C-reactive protein (DAS28-CRP) or Disease Activity in Psoriatic Arthritis (DAPSA) measures for RA and PsA, respectively, or in the percentage of patients in remission or with low disease activity compared with baseline.…”

Section: Resultsmentioning

confidence: 99%

Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching

Cohen,

Bodenmueller

2024

BioDrugs

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As of 31 December, 2023, 31 observational studies have been published, including a total of 6081 patients who underwent a switch from one biosimilar to another biosimilar of the same reference biologic. Most studies evaluated infliximab, while a smaller number evaluated adalimumab, rituximab or etanercept. Indications studied now include sarcoidosis, as well as the indications previously reported of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis/ankylosing spondylitis and inflammatory bowel disease (Crohn’s disease and ulcerative colitis). This updated data set includes eight additional studies and 2386 more patients compared with those included in an earlier systematic review of biosimilar-to-biosimilar switching. In addition, since the earlier systematic review was published in 2022, the European Medicines Agency has stated that reference-to-biosimilar and biosimilar-to-biosimilar switching in the European Union is safe and efficacy remains unchanged after switching. Furthermore, following a review of the available evidence, the US Food and Drug Administration has confirmed that initial safety and immunogenicity concerns related to biosimilar switching are unfounded and that no differences are observed in efficacy, safety or immunogenicity following one or more switches. The availability of this new efficacy and safety data together with the supportive statements from the European Medicines Agency and the Food and Drug Administration re-confirm the conclusion that as a scientific matter, biosimilar-to-biosimilar switching is an effective clinical practice, with no new safety concerns. Any suggestions to the contrary are not supported by the evidence.

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Section: Resultsmentioning

confidence: 99%

Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching

Cohen,

Bodenmueller

2024

BioDrugs

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“…Finally, Roccuzzo G et al [24] reported high discontinuation rates among biosimilar users due to severe pain at the injection site. Only Scrivo et al [25] evaluated the effects of the switch among adalimumab biosimilars. They carried out a prospective cohort study among 150 patients, of whom 110 (40 with PsA) switched from the adalimumab originator to the SB5 biosimilar and 40 (25 with PsA) switched from the ABP501 biosimilar to the SB5 biosimilar.…”

Section: Main Outcomes Main Resultsmentioning

confidence: 99%

“…Fourteen studies [13][14][15][16][17][18][19][20][21][22][23][24][25]49] evaluated the effects in terms of the efficacy and safety derived from the switch among adalimumab products. All studies were carried out in Europe (10/14 in Italy).…”

Section: Adalimumab Switching Studiesmentioning

confidence: 99%

“…No statistically significant differences were found in the incidence of AEs before and after the switch Roccuzzo, [24] Efficacy (IHS4, HiSCR) and safety (AEs) No significant differences were found between adalimumab originators and biosimilars in terms of the clinical response following nonmedical switch. At the 1-year follow up, 16 patients (43.2%) discontinued the treatment (8 due to treatment inefficacy, 5 due to severe injection site pain, and 3 for unspecified reasons) Scrivo R, [25] Efficacy Out of 79 patients undergoing non-medical switching, 53 successfully completed the 12-months of follow-up of the study, while 26 patients interrupted SB4 treatment prematurely (19 cases of loss of efficacy of the drug and 7 cases of AEs, which included psoriasis, hypertension, cancer, and lower respiratory tract infection). Among naïve patients, 33 after 1 year were responders while 12 were non-responders (of these patients, 10 reported a loss of efficacy and 2 experienced AEs)…”

Section: Adamentioning

confidence: 99%

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Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Nicoletti

Pentella

et al. 2023

Biologics

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Background. Although biosimilars have been increasingly used over recent years, some concerns about a potential loss of efficacy and altered safety profile when switching from an originator to a biosimilar still exist. Interchangeability can be a challenge for dermatologists too. An extensive systematic review of published switching studies among originators and biosimilars was carried out in order to provide evidence regarding the effects derived from the switch in terms of efficacy and safety outcomes in real-life contexts. Results. Thirty-seven articles were included in this systematic review (14 studies related to adalimumab, 10 to etanercept, 12 to infliximab, and 1 each to adalimumab, etanercept, and infliximab). Studies were mainly carried out among European countries. Most of them were observational studies or register-based studies. The majority of studies enrolled patients diagnosed with psoriasis or psoriatic arthritis who underwent a single switch from the originator to the biosimilar. Overall, the studies’ results demonstrated that switching between adalimumab, etanercept, and infliximab originators and biosimilars is safe and effective in a real-life setting of patients with dermatological conditions. Only a few studies highlighted an increase in the risk of loss of efficacy as well as an increased rate of AEs, both of which were identified as the main causes of biosimilar discontinuation, probably associated with the well-known phenomenon of the nocebo effect. Conclusion. Switching from a biologic originator to its biosimilar is safe and effective. Only a few studies have evaluated the switch among biosimilars; thus, no firm conclusion can be drawn for this type of switch in terms of the efficacy and safety outcomes. Based on our results, we believe that biosimilars can be considered interchangeable with their reference products and that no additional switch studies are necessary to support switching among originators and biosimilars in clinical practice. However, the continuous monitoring of all biologics (both originators and biosimilars) in routine clinical practice is strongly needed given their peculiar safety profile.

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Knowledge mapping of biological disease-modifying anti-rheumatic drugs for axial spondyloarthritis: a bibliometric study

Chen

Liao

et al. 2023

Clin Rheumatol

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Effectiveness of non-medical switch from adalimumab bio-originator to SB5 biosimilar and from ABP501 adalimumab biosimilar to SB5 biosimilar in patients with chronic inflammatory arthropathies: a monocentric observational study

Cited by 4 publications

References 0 publications

Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching

Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching

Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Knowledge mapping of biological disease-modifying anti-rheumatic drugs for axial spondyloarthritis: a bibliometric study

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