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INTRODUCTION: To assess the clinical and cost-effectiveness of therapeutic drug monitoring (TDM) based on serum adalimumab levels compared to standard of care in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. METHODS: This was a non-inferiority, multicentric, non-randomized, pragmatic trial including adult patients diagnosed with moderate-to-severe, clinically stable rheumatic diseases treated with adalimumab. Consecutive patients were assigned 1:2 to the control (CG) or the intervention group (IG), based on the site of inclusion, and followed up for 18 months. Adalimumab serum levels were measured at each study visit and released to the IG only to modify dosing strategy. Data on disease activity, healthcare resource utilization and health-related quality of life (HRQoL) measured through the EQ-5D-5L were collected. Number of persistent and overall flares, time to first flare, days experiencing high disease activity, total direct costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated. RESULTS: Of the 169 recruited patients, 150 were included in the analysis (52 and 98 patients in the CG and IG, respectively). The primary endpoint was not met as persistent flares were not significantly lower in the IG, although mean (SD) number of flares was numerically lower in the IG (0.67 [0.70] versus 0.90 [0.82], P = 0.073), respectively. Based on EQ-5D-5L utilities, HRQoL was significantly higher in the IG at 3 (P = 0.001) and 6 months (P = 0.035), which overall translated into 0.075 QALYs gained per patient for the IG at month 18. Overall, direct costs were significantly lower for the IG patients (15,311.59 [4,870.04] versus 17,378.46 [6,556.51], P = 0.030), resulting in the intervention being dominant, leading to increased QALY at a lower overall cost CONCLUSION: Adalimumab dose tapering based on TDM for rheumatic patients led to an increased quality of life and QALY gain and entailed lower costs, being a more cost-effective alternative than clinically guided management.
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BACKGROUND: The aim of the current study was to validate the self-report section of the American Shoulder and Elbow Surgeons questionnaire (ASES-p) into Spanish. METHODS: Shoulder pathology patients were recruited and followed up to 6 months post treatment. The ASES-p, Constant, SF-36 and Barthel scales were filled-in pre and post treatment. Reliability was tested with Cronbach's alpha, convergent validity with Spearman's correlations coefficients. Confirmatory factor analysis (CFA) and the Rasch model were implemented for assessing structural validity and unidimensionality of the scale. Models with and without the pain item were considered. Responsiveness to change was explored via standardised effect sizes. RESULTS: Results were acceptable for both tested models. Cronbach's alpha was 0.91, total scale correlations with Constant and physical SF-36 dimensions were >0.50. Factor loadings for CFA were >0.40. The Rasch model confirmed unidimensionality of the scale, even though item 10 "do usual sport" was suggested as non-informative. Finally, patients with improved post treatment shoulder function and those receiving surgery had higher standardised effect sizes. CONCLUSIONS: The adapted Spanish ASES-p version is a valid and reliable tool for shoulder evaluation and its unidimensionality is supported by the data.
