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.
MethodsA 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.
ResultsLevels 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.
ConclusionsPatients 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.
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.
MétodosSe 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.
ResultadosLos 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.
ConclusionesLos 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.
Psoriatic arthritis is an inflammatory joint disease that occurs in the context of a patient with cutaneous psoriasis or a first-degree family history of the condition.1,2 It has a prevalence of 6–25 cases per 10,000 people and affects 20%–30% of patients with this skin involvement.3,4 Psoriatic arthritis can present as a form of peripheral involvement in the form of asymmetric oligoarthritis or symmetric polyarthritis and/or in the form of axial involvement correlating with inflammatory lumbosacral pain and back stiffness, which can lead to functional impairment and reduced quality of life.5,6
The interleukin IL-23/IL-17A axis is known to be involved in a variety of biological functions such as inflammation, joint damage and injury, and is also present in the pathogenic mechanism of psoriatic arthritis and spondylitis.7 Recent studies have shown that inhibition of the IL-17A receptor with secukinumab, an anti-human IL-17A monoclonal antibody, improves the signs and symptoms of the disease.7–9However, the multifactorial nature of the disease make it difficult to use measures that reflect changes in the course of treatment and its impact on the patient's quality of life.
In recent years, several questionnaires10–12 have been developed to assess the efficacy and effectiveness of health interventions on the premise that the patient's point of view should be included in assessing the relative merits of treatments in clinical trials.13 From this perspective, in our study we analysed the effect of secukinumab on patient-reported variables, namely fatigue, sleep and quality of life in patients with psoriatic arthritis and/or spondyloarthritis.
Material and methodsA multicentre, observational, longitudinal, and prospective 6-month study was conducted in which 39 patients from the Valencia area were selected and consecutive sampling was conducted of all those starting treatment with secukinumab with any rheumatological indication.
The main variables were changes in patient-reported measures, evaluating overall health both at the initial visit and at 6 months using a visual analogue scale (VAS). Fatigue measures were also collected from each patient using the FACIT-fatigue scale. The Insomnia Severity Index was used for sleep assessment and the EuroQol-3L-5D and PsAQoL questionnaires for patient quality of life. The delivery method of secukinumab (as monotherapy or with DMARDs), the administration of previous biologics and the patient's corticosteroid or NSAID medication during the study were used as confounding criteria. In addition, depending on the type of disease (peripheral psoriatic or spondyloarthritis), the DAS28 with velocity or BASDAI, respectively, were recorded.
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The FACIT Scale is a 13-item questionnaire. Each response is assessed on a 5-point Likert-type scale, with 0 being no problem and 4 being the maximum amount, and includes items such as fatigue, weakness, apathy, lack of energy and the impact these feelings have on the patient. The overall range of the scale is from 0 to 52, with lower values denoting higher levels of fatigue.4,11,14
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The Insomnia Severity Index (ISI) is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are severity of sleep onset and problems with early morning awakening problems, sleep dissatisfaction, sleep difficulties, noticeability of sleep problems by others. Each item is rated on a 5-point Likert scale, with 0 being no problem and 4 very severe problem. Thus, a scale is generated where 0–7 is interpreted as absence of insomnia; 8–14 sub-threshold insomnia; 15–21 moderate insomnia; 22–28 severe insomnia.15
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The EuroQol-5D-3L (EQ-5D) is a generic instrument for measuring quality of life by which patients themselves evaluate their state of health by dimensions on mobility, self-care, activities of daily living, pain and discomfort, anxiety, and depression. Each of these is scored as 3 levels of severity and an overall VAS assessment. A third element of the EQ-5D is the social value index, which consists of 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression), each of which is scored from one to three, with 1 being no problems and 3 being extreme problems. The second part of the EQ-5D is a VAS in which the patient assesses his or her general health state on a scale from 0 to 100, where 0 is the best possible health state and 100 the worst, the least significant difference being 10.16
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The PsAQoL questionnaire is a specific instrument for assessing quality of life. It consists of 20 yes/no questions derived directly from qualitative patient interviews and is successfully used in diseases such as rheumatoid arthritis, spondylitis, and lupus erythematosus. The total score is calculated as the number of affirmative questions and can range from 0 to 20, with higher values indicating poor quality of life.17
Statistical analysis of the samples was performed using measures of central tendency, changes were analysed after 6 months using the Student's t-test for paired data in the case of the FACIT, VAS, PsAQoL and ISI and the chi-squared test for the dimensions of the EQ-5D questionnaire. Changes in patient-reported measures were analysed in multiple linear regression models with 95% confidence intervals. The effect size of each measure was calculated using Cohen's d (mean difference/aggregate variance). Results were analysed by disease group and overall using Stata v12 (College Station, Tx, USA).
ResultsThe 39 patients under study were classified into two groups according to whether they had psoriatic arthritis or spondyloarthritis, with a mean age of 50.2 ± 13.4 and 41.2 ± 10.9 years, respectively. Of these, 54% had a predominantly axial picture and the remaining 46% had peripheral arthritis. Regarding the drugs used as therapy, treatment either in combination with a disease modifying drug or with corticosteroids was more frequent in the patients with peripheral than in those with axial predominance (Table 1). In addition, approximately half the patients in each group had been treated with a previous biological agent.