Biosimilar versus originator etanercept: a real-life clinical study.


Journal

Italian journal of dermatology and venereology
ISSN: 2784-8450
Titre abrégé: Ital J Dermatol Venerol
Pays: Italy
ID NLM: 101778002

Informations de publication

Date de publication:
Aug 2022
Historique:
pubmed: 12 3 2022
medline: 4 8 2022
entrez: 11 3 2022
Statut: ppublish

Résumé

Over the last few years, novel therapeutic approaches based on the use of monoclonal antibodies against cytokines, or their cognate receptors, involved in psoriasis progression have shown remarkable results, being capable to reduce disease progression and increase patient's quality of life. Among these is etanercept (Enbrel For this purpose, we analyzed a case study consisting of 65 patients affected by plaque psoriasis, with or without psoriatic arthritis at our dermatological outpatient center of Sant'Andrea Hospital in Rome, all of them under treatment with either ETN or the biosimilar SB4 drug for at least 3 months. The indicators used to evaluate the effectiveness of the therapies were the Psoriasis Area and Severity Index, the Visual Analogue Scale (VAS) for itch, the VAS for pain, and the Dermatology Life Quality Index. The results showed no significant differences among the two drugs in all the analyzed parameters confirming the equivalence between the ETN and its biosimilar SB4. Overall, we can confirm the overlapping clinical efficacy between ETN and its biosimilar SB4 drug and that even in an uncontrolled environment such as real-life, the biosimilar drugs are an excellent opportunity to reduce health costs allowing to expand the audience of patients who can benefit from these innovative treatments.

Sections du résumé

BACKGROUND BACKGROUND
Over the last few years, novel therapeutic approaches based on the use of monoclonal antibodies against cytokines, or their cognate receptors, involved in psoriasis progression have shown remarkable results, being capable to reduce disease progression and increase patient's quality of life. Among these is etanercept (Enbrel
METHODS METHODS
For this purpose, we analyzed a case study consisting of 65 patients affected by plaque psoriasis, with or without psoriatic arthritis at our dermatological outpatient center of Sant'Andrea Hospital in Rome, all of them under treatment with either ETN or the biosimilar SB4 drug for at least 3 months. The indicators used to evaluate the effectiveness of the therapies were the Psoriasis Area and Severity Index, the Visual Analogue Scale (VAS) for itch, the VAS for pain, and the Dermatology Life Quality Index.
RESULTS RESULTS
The results showed no significant differences among the two drugs in all the analyzed parameters confirming the equivalence between the ETN and its biosimilar SB4.
CONCLUSIONS CONCLUSIONS
Overall, we can confirm the overlapping clinical efficacy between ETN and its biosimilar SB4 drug and that even in an uncontrolled environment such as real-life, the biosimilar drugs are an excellent opportunity to reduce health costs allowing to expand the audience of patients who can benefit from these innovative treatments.

Identifiants

pubmed: 35274881
pii: S2784-8671.22.07224-3
doi: 10.23736/S2784-8671.22.07224-3
doi:

Substances chimiques

Biosimilar Pharmaceuticals 0
Etanercept OP401G7OJC

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

318-324

Auteurs

Domenico Giordano (D)

Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University, Rome, Italy.

Alessandro Capalbo (A)

Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University, Rome, Italy.

Nazareno Gagliostro (N)

Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University, Rome, Italy.

Giusy Fedele (G)

National Institute of Oceanography and Experimental Geophysics, Sgonico, Trieste, Italy.

Charalampos G Balampanos (CG)

Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University, Rome, Italy.

Flavia Persechino (F)

Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy.

Vilma Bushati (V)

Nostra Signora del Buon Consiglio Catholic University, Tirana, Albania.

Salvatore Ulisse (S)

Department of Surgical Sciences, Sapienza University, Rome, Italy.

Severino Persechino (S)

Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University, Rome, Italy - severino.persechino@uniroma1.it.

Giovanni Pellacani (G)

Section of Dermatology, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy.

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Classifications MeSH