Abstract
There is a significant rate of therapeutic failure in rheumatoid arthritis (RA) patients treated with leflunomide (LEF). This study investigates the utility values of teriflunomide levels (A77 1726) in identifying RA patients who remained with moderate or severe disease activity after the treatment with LEF. In this cross-sectional study, we compared: (a) RA patients who achieved a DAS28-ESR ≤ 3.2, and (b) RA patients who maintained a DAS28-ESR > 3.2 after treatment. ROC curves determined the cut-off of A77 1726 with the better performance to identify patients achieving a DAS28-ESR ≤ 3.2. Of the 115 patients treated with LEF, 69 (60%) remained with moderate/severe disease activity and 46 (40%) achieved low disease activity/remission. Higher A77 1726 levels showed a negative correlation with DAS28-ESR (r = − 0.42, p < 0.001) and other parameters of disease activity. We obtained the following utility values with the cut-off of A77 1726 > 10 µg/mL to identify RA patients who achieved a DAS28-ESR ≤ 3.2: sensitivity of 91.31%; specificity of 73.91%; positive predictive value of 70.00%; and negative predictive value of 92.73%. Serum A77 1726 discriminated between RA patients who remained with moderate/severe disease activity despite the treatment with LEF both as monotherapy and LEF as combo therapy.
Highlights
Rheumatoid arthritis (RA) is an autoimmune systemic disease characterized by chronic synovitis involving synovial joints that lead to joint destruction, functionality loss, and health-related quality-of-life impairment[1,2]
There are a limited number of studies that assess the relationship between A77 1726 concentrations and therapeutic response to LEF administered as monotherapy in rheumatoid arthritis (RA) patients[13,14]; there are no studies that assess the value of teriflunomide levels in identifying those patients who achieved a DAS28-ESR ≤ 3.2 when treated with LEF as combo conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy in RA patients
In the second subgroup analysis, we included RA patients treated with LEF as combo therapy with other DMARDs (n = 61). In this subgroup treated with LEF as combo therapy, RA patients with serum levels of A77 1726 > 10 μg/mL (n = 33) had lower DAS28-ESR compared with those with serum levels of A77 1726 ≤ 10.0 μg/mL (n = 28) (3.6 ± 1.2 and 5.3 ± 1.1, respectively; p < 0.001). These findings indicate that serum levels of A77 1726 constitute a good marker of therapeutic response, independently of whether LEF was prescribed as monotherapy or if it was prescribed in combination with other DMARDs
Summary
Rheumatoid arthritis (RA) is an autoimmune systemic disease characterized by chronic synovitis involving synovial joints that lead to joint destruction, functionality loss, and health-related quality-of-life impairment[1,2]. There are a limited number of studies that assess the relationship between A77 1726 concentrations and therapeutic response to LEF administered as monotherapy in RA patients[13,14]; there are no studies that assess the value of teriflunomide levels in identifying those patients who achieved a DAS28-ESR ≤ 3.2 when treated with LEF as combo csDMARD therapy in RA patients. The present study aimed to investigate the utility values of teriflunomide (A77 1726) levels in identifying rheumatoid arthritis (RA) patients who remained with moderate or severe disease activity after treatment with leflunomide (LEF), either as monotherapy or in combination with other disease-modifying antirheumatic drugs
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