Estudio prospectivo multicéntrico de experiencia en práctica clínica real en el control de medidas de desenlace reportadas por el paciente (PRO) diagnosticado de artritis psoriásica y/o espondiloartritis y que inicia tratamiento con secukinumab / Prospective multicentre study of experience in real-world clinical practice in monitoring reported outcome measures (PROMs) of patient with a diagnosis of psoriatic and/or spondyloarthritis and initiating treatment with secukinumab

Objetivo: Analizar el efecto del secukinumab sobre las variables propias reportadas por el paciente diagnosticado de artritis psoriásica y/o espondilitis anquilosante en relación con su estado de salud, dolor, fatiga, sueño y calidad de vida. Métodos: Se realizó un estudio observacional, longitudinal, prospectivo y multicéntrico a 6meses con 39 pacientes que iniciaron tratamiento con secukinumab para la terapia de artritis psoriásica y/o espondilitis. Las variables principales fueron los cambios en las medidas reportadas por el paciente, evaluándolas por medio de los cuestionarios FACIT-fatiga, Índice de Gravedad del Insomnio, EuroQol-3L-5D y PsAQoL. Adicionalmente, y dependiendo del tipo de enfermedad (psoriásica periférica o espondiloartritis), se recogió el DAS28 con velocidad o el BASDAI, respectivamente. Resultados: Los niveles de fatiga, insomnio moderado y grave presentan una reducción significativa tras el tratamiento de 6meses con secukinumab. Al mismo tiempo, la calidad de vida reportada por el paciente aumenta notablemente (p=0,006). Los datos referentes al dolor y a la incomodidad también presentan una notable mejoría tras el tratamiento. Conclusiones: Los pacientes de artritis psoriásica y/o espondilitis anquilosante que inician tratamiento con secukinumab presentan mejoría a los 6meses en todos los tamaños del efecto del tratamiento, particularmente en el sueño, la fatiga y la calidad de vida. Además, las medidas de desenlace reportadas por los pacientes son un valor clínico adicional y permiten realizar una valoración más exacta y aproximada de su estado real de salud y bienestar.(AU)

Objective: To analyse the effect of secukinumab on self-reported variables of patients diagnosed with psoriatic arthritis and/or ankylosing spondylitis in relation to their health status, pain, fatigue, sleep and quality of life. Methods: A six-month, observational, longitudinal, prospective, multicentre study was conducted with 39 patients who initiated treatment with secukinumab as therapy for psoriatic arthritis and/or spondylitis. The main variables were changes in patient-reported measures and they were evaluated by means of the questionnaires: FACIT-fatigue, Insomnia Severity Index, EuroQol-3L-5D and PsAQoL. In addition, depending on the type of disease (peripheral psoriasis or spondyloarthritis) the DAS28 with ESR or the BASDAI were calculated, respectively. Results: Levels of fatigue, moderate and severe insomnia significantly reduced after 6months of treatment with secukinumab. At the same time, patient-reported quality of life increased significantly (P=.006). Data on pain and discomfort also show significant improvement after the treatment. Conclusions: Patients with psoriatic arthritis and/or ankylosing spondylitis who start treatment with secukinumab show improvement at 6months in all effect sizes of the treatment, particularly in sleep, fatigue and quality of life. Furthermore, patient-reported outcome measures are of additional clinical value and allow more accurate and closer assessment of their real status of health and well-being.(AU)

Prospective multicentre study of experience in real-world clinical practice in monitoring reported outcome measures (PROMs) of patient with a diagnosis of psoriatic and/or spondyloarthritis and initiating treatment with secukinumab. / Estudio prospectivo multicéntrico de experiencia en práctica clínica real en el control de medidas de desenlace reportadas por el paciente (PRO) diagnosticado de artritis psoriásica y/o espondiloartritis y que inicia tratamiento con secukinumab.

OBJECTIVE: To analyse the effect of secukinumab on self-reported variables of patients diagnosed with psoriatic arthritis and/or ankylosing spondylitis in relation to their health status, pain, fatigue, sleep and quality of life. METHODS: A six-month, observational, longitudinal, prospective, multicentre study was conducted with 39 patients who initiated treatment with secukinumab as therapy for psoriatic arthritis and/or spondylitis. The main variables were changes in patient-reported measures and they were evaluated by means of the questionnaires: FACIT-fatigue, Insomnia Severity Index, EuroQol-3L-5D and PsAQoL. In addition, depending on the type of disease (peripheral psoriasis or spondyloarthritis) the DAS28 with ESR or the BASDAI were calculated, respectively. RESULTS: Levels of fatigue, moderate and severe insomnia significantly reduced after 6months of treatment with secukinumab. At the same time, patient-reported quality of life increased significantly (P=.006). Data on pain and discomfort also show significant improvement after the treatment. CONCLUSIONS: Patients with psoriatic arthritis and/or ankylosing spondylitis who start treatment with secukinumab show improvement at 6months in all effect sizes of the treatment, particularly in sleep, fatigue and quality of life. Furthermore, patient-reported outcome measures are of additional clinical value and allow more accurate and closer assessment of their real status of health and well-being.