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Published in: International Journal of Clinical Pharmacy 1/2019

01-02-2019 | Etanercept | Short Research Report

Clinical experience with the etanercept biosimilar SB4 in psoriatic patients

Authors: L. Pescitelli, L. Lazzeri, A. Di Cesare, L. Tripo, F. Ricceri, F. Prignano

Published in: International Journal of Clinical Pharmacy | Issue 1/2019

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Abstract

Background After the expiry of the patent of reference etanercept, several biosimilars have been developed, including SB4. Objective To study safety and efficacy of SB4 in psoriatic patients previously treated with etanercept and in the etanercept naive ones. Method Patients affected by moderate to severe psoriasis and/or psoriatic arthritis attending the Psoriasis Center of Florence University, treated with SB4 were enrolled in the study. Patients were divided in two cohorts. Cohort 1 included 32 patients who were switched from previous etanercept, cohort 2 included 12 patients who were naive to etanercept. Results Evaluation of the efficacy of SB4 in cohort 1 patients revealed rates of clinical remission (defined as both PASI and/or DAS28 increase < 10%) of 92% and 64% for psoriasis and psoriatic arthritis respectively. In cohort 2 at week 24 PASI 75 was observed in 75% of patients. Conclusion In our experience switching from originator to SB4 in psoriatic patients seems not to influence efficacy, especially cutaneous manifestations, over a median observational period of 24 weeks.
Literature
1.
go back to reference Scott LJ. Etanercept: a review of its use in autoimmune inflammatory diseases. Drugs. 2014;74(12):1379–410.CrossRefPubMed Scott LJ. Etanercept: a review of its use in autoimmune inflammatory diseases. Drugs. 2014;74(12):1379–410.CrossRefPubMed
2.
go back to reference Prinz JC, Puig L, Girolomoni G. Treatment of psoriasis with etanercept: the typical patient profile. J Eur Acad Dermatol Venereol. 2016;30(7):1092–9.CrossRefPubMed Prinz JC, Puig L, Girolomoni G. Treatment of psoriasis with etanercept: the typical patient profile. J Eur Acad Dermatol Venereol. 2016;30(7):1092–9.CrossRefPubMed
3.
go back to reference Weise M, Bielsky M-C, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars-why terminology matters. Nat Biotechnol. 2011;29(8):690–3.CrossRefPubMed Weise M, Bielsky M-C, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars-why terminology matters. Nat Biotechnol. 2011;29(8):690–3.CrossRefPubMed
4.
go back to reference Cho IH, Lee N, Song D, Jung SY, Bou-Assaf G, Sosic Z, et al. Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept. mAbs. 2016;8(6):1136–55.CrossRefPubMedPubMedCentral Cho IH, Lee N, Song D, Jung SY, Bou-Assaf G, Sosic Z, et al. Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept. mAbs. 2016;8(6):1136–55.CrossRefPubMedPubMedCentral
5.
go back to reference Burness CB, Duggan ST. Etanercept (SB4): a Review in Autoimmune Inflammatory Diseases. BioDrugs Clin Immunother Biopharm Gene Ther. 2016;30(4):371–8. Burness CB, Duggan ST. Etanercept (SB4): a Review in Autoimmune Inflammatory Diseases. BioDrugs Clin Immunother Biopharm Gene Ther. 2016;30(4):371–8.
6.
go back to reference Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76(1):51–7.CrossRefPubMed Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76(1):51–7.CrossRefPubMed
7.
go back to reference Moots R, Azevedo V, Coindreau JL, Dörner T, Mahgoub E, Mysler E, et al. Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the clinician. Curr Rheumatol Rep. 2017;19(6):37.CrossRefPubMedPubMedCentral Moots R, Azevedo V, Coindreau JL, Dörner T, Mahgoub E, Mysler E, et al. Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the clinician. Curr Rheumatol Rep. 2017;19(6):37.CrossRefPubMedPubMedCentral
8.
go back to reference Egeberg A, Ottosen MB, Gniadecki R, Broesby-Olsen S, Dam TN, Bryld LE, et al. Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2):509–19.CrossRefPubMed Egeberg A, Ottosen MB, Gniadecki R, Broesby-Olsen S, Dam TN, Bryld LE, et al. Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2):509–19.CrossRefPubMed
10.
go back to reference Gerdes S, Thaçi D, Griffiths CEM, Arenberger P, Poetzl J, Wuerth G, Afonso M, Woehling H. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study. J Eur Acad Dermatol Venereol. 2018;32(3):420–7.CrossRefPubMed Gerdes S, Thaçi D, Griffiths CEM, Arenberger P, Poetzl J, Wuerth G, Afonso M, Woehling H. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study. J Eur Acad Dermatol Venereol. 2018;32(3):420–7.CrossRefPubMed
Metadata
Title
Clinical experience with the etanercept biosimilar SB4 in psoriatic patients
Authors
L. Pescitelli
L. Lazzeri
A. Di Cesare
L. Tripo
F. Ricceri
F. Prignano
Publication date
01-02-2019
Publisher
Springer International Publishing
Published in
International Journal of Clinical Pharmacy / Issue 1/2019
Print ISSN: 2210-7703
Electronic ISSN: 2210-7711
DOI
https://doi.org/10.1007/s11096-018-0769-7

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