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Italian Journal of Dermatology and Venereology 2022 August;157(4):318-24

DOI: 10.23736/S2784-8671.22.07224-3


language: English

Biosimilar versus originator etanercept: a real-life clinical study

Domenico GIORDANO 1, Alessandro CAPALBO 1, Nazareno GAGLIOSTRO 1, Giusy FEDELE 2, Charalampos G. BALAMPANOS 1, Flavia PERSECHINO 3, Vilma BUSHATI 4, Salvatore ULISSE 5, Severino PERSECHINO 1 , Giovanni PELLACANI 6

1 Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University, Rome, Italy; 2 National Institute of Oceanography and Experimental Geophysics, Sgonico, Trieste, Italy; 3 Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy; 4 Nostra Signora del Buon Consiglio Catholic University, Tirana, Albania; 5 Department of Surgical Sciences, Sapienza University, Rome, Italy; 6 Section of Dermatology, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy

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®, Pfizer, Sandwich, UK) and its biosimilar compound SB4 (Benepali®, Samsung Bioepis, Delft, The Netherlands), both approved for the treatment of moderate to severe psoriasis. Aim of the present study was to evaluate in a less controlled environment, such as real-life, the actual bioequivalence between the etanercept (ETN) and the SB4 in term of safety, efficacy and patient’s quality of life.
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. 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: 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.

KEY WORDS: Psoriasis; Etanercept; Biosimilar pharmaceuticals; Visual Analogue Scale

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