| Autor: |
Herranz Pinto, Pedro Francisco, Alonso Pacheco, Maria Luisa, Feltes Ochoa, Rosa, Mayor Ibarguren, Ander, Servera Negre, Guillermo, Busto Leis, Jose Manuel, Gonzalez Fernández, Maria Angeles, Herrero Ambrosio, Alicia |
| Přispěvatelé: |
UAM. Departamento de Medicina |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
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| Popis: |
Background Guselkumab is a drug used to treat moderate to severe plaque psoriasis. However, real-life clinical data on its of-label use are limited, especially regarding the optimal drug dosage regimen for diferent patient profles. Objective The main objective of this real-world, single-centre, retrospective study was to identify the of-label guselkumab dosing regimen used in clinical practice. The study also aimed to evaluate the drug's efcacy, safety, and survival, as well as the proportion of super-responders (SR) based on a newly proposed defnition. Methods The study included 69 patients who started treatment with guselkumab between March 2019 and July 2021. Patients were followed up until April 2022, during which time their efcacy, safety, persistence, and use of guselkumab were recorded. Patients were aged ≥ 18 years and had moderate to severe plaque psoriasis. Results The mean disease duration was 18.6 years, and 59% of patients had received at least one biologic treatment before guselkumab with a mean of 1.3 biologics per patient. The initial absolute Psoriasis Area and Severity Index (PASI) was 10.1 and decreased to 2.1 between Week 11–20 without signifcant changes in the PASI value throughout the 90 weeks of followup. The cumulative probability of drug survival was 93.5% at Week 52. No diferences were found in terms of efcacy and survival associated with the of-label drug dosage regimens compared to the doses described in the Summary of Product Characteristics (SmPC). The greatest adjustments in the drug administration regimen were achieved in the subgroups of bionaïve and SR patients, with a reduction in the number of administrations by 40% and 47% compared to the regimen described in the SmPC. Super-response to guselkumab was mainly associated with patients naïve to previous biologic treatment. Conclusion The study demonstrated that of-label use of guselkumab was safe and efective in real-life clinical practice. The fndings suggest that adjustments to the drug administration regimen may be necessary to optimise its use in diferent patient profles, especially in SR and bio-naïve patients. Further studies are needed to confrm these fndings |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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