Patient-reported outcomes in patients with advanced ankylosing spondylitis treated by etanercept biosimilar: a retrospective study based on propensity score matching

  Objective  To analyze clinical effect of etanercept on patient-reported outcomes (PROs) in patients with advanced ankylosing spondylitis(AS).

  Methods  Clinical data of 145 patients with advanced AS were retrospective analyzed, and the patients were divided into etanercept biosimilar group (Bg group, n=43) and abiotic agent group (nBg group, n=102). After a ratio of 1 to 1 propensity score matching (PSM), 37 patients were enrolled in the Bg group and nBg group, respectively, and their PROs at 4 and 12 weeks were analyzed. Ankylosing spondylitis quality of life (ASQoL), Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Euro-QoL-Visual Analogue Scale (EQ-VAS) of Euro-QoL-5-dimension health status questionnaire (EQ-5D), and Work Productivity and Activity Impairment-General Health questionnaire (WPAI-GH), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index(BASFI) were used to evaluate the score of each item.

  Results  At 4 and 12 weeks, the improvement of BASDAI score in the Bg group was better than that in the nBg group (P < 0.05 or P < 0.01). At 12 weeks, Bg group had more significant improvement in the Bg group in ASQoL score (P < 0.05). At 4 and 12 weeks, the improvement degree of HAQ-DI, FACIT-F and over all work impairment score of WPAI-GH in the Bg group was better than that in the nBg group (P < 0.05). At the 12th week of treatment, the proportions of patients with improvement ≥MCID of HAQ-DI and ASQoL scores in the Bg group were 91.89% and 97.30%, respectively, which were higher than 59.46% and 67.57% in the nBg group (P < 0.05). At the 4th and 12th week of treatment, the proportions of patients with improvement score ≥MCID of FACIT-F score in the Bg group were 75.68% and 91.89%, which were higher than 43.24% and 51.35% in the nBg group (P < 0.001). In patients with high disease activity (BASDAI scored ≥4) at baseline, the proportion of patients with low disease activity (BASDAI scored < 4) in the Bg group was significantly higher than that in the nBg group at week 12 (P=0.002).

  Conclusion  Etanercept biosimilar improves health-related quality of life, disease activity and work efficiency in patients with advanced AS. Therefore, patients with advanced AS can still benefit from treatment of etanercept biosimilar.