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Original Article
Available online 8 April 2021
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
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Juan José Lerma Garridoa,
Corresponding author
jjlerma@comv.es

Corresponding author.
, Antonio Gracia Pérezb, Antonio Pérez Torresc, Amalia Rueda Cida, Clara Molina Almelaa, María Dolores Pastor Cubilloa, Cristina Campos Fernándeza, Isabel Balaguer Trulla, Loreto Carmonad, Javier Calvo Cataláa
a Hospital General Universitario de Valencia, Valencia, Spain
b Hospital de Sagunto, Sagunto, Valencia, Spain
c Hospital de Lliria, Llíria, Valencia, Spain
d Instituto de Salud Musculoesquelética, Madrid, Spain
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Tables (4)
Table 1. Baseline description of the 39 patients in the study.
Table 2. Changes in each of the patient centred variables after 6 months of therapy with secukinumab.
Table 3. Changes in the EuroQuoL-5D after six months’ treatment with secukinumab.
Table 4. Changes in levels of insomnia after 6 months’ treatment.
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Abstract
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 6 months 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 6 months 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.

Keywords:
Secukinumab
Patient-reported outcomes
Quality of life
Fatigue
Sleep
Clinical practice
Resumen
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 6 meses 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 6 meses 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 6 meses 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.

Palabras clave:
Secukinumab
Resultados reportados por el paciente
Calidad de vida
Fatiga
Sueño
Práctica clínica

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