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TOVERA: Ultrasound is a promising biomarker of early treatment response

Presented By
Dr Maria Stoenoiu, Cliniques Universitaires Saint-Luc, Belgium
EULAR 2021
Phase 3, TOVERA
In patients with very early rheumatoid arthritis (RA) on methotrexate plus tocilizumab combination therapy, ultrasound imaging was able to detect treatment response in an earlier stage than clinical examination scores. Therefore, ultrasound is a potential imaging biomarker of treatment response in this specific patient population. These were findings of the open-label TOVERA study.

Ultrasound is an established imaging tool in RA management, though evidence on the applicability of ultrasound in very early RA patients on methotrexate plus tocilizumab combination therapy is limited. In the open-label, single-arm, phase 3 TOVERA study (NCT02837146), 44 very early RA patients naïve to DMARDs (mean age 46.7) completed the 24-week methotrexate (15–20 mg/week) plus tocilizumab (162 mg/week) induction therapy.

Both grayscale (GS) and Global OMERACT-EULAR Synovitis Score (GLOESS) scores detected a significant treatment response 2 weeks after treatment initiation on the 17-joint score (whole joint set; P<0.01), 12-joint score (P<0.05), and 10-joint score (wrists, MCP, ankles, MTP joints; P<0.05). In contrast, the clinical examination scores Disease Activity Score (DAS)-28 and Clinical Disease Activity Index (CDAI) only detected a significant treatment response at 4 weeks (DAS-28) or 8 weeks (CDAI; P<0.001) of therapy. Power-doppler scores recognised a first treatment response at 4 weeks. Patient-reported measures of disease activity –visual analogue scale (VAS) and Health Assessment Questionnaire (HAQ)– detected a first treatment response 8 weeks after the initiation of induction therapy (P<0.001). VAS fatigue scores only noticed treatment response after 12 weeks.

Dr Maria Stoenoiu (Cliniques Universitaires Saint-Luc, Belgium) argued that these results demonstrate that ultrasound is a promising imaging biomarker of early treatment response in very early RA patients. She concluded that this easy-to-use imaging tool could be used in addition to clinical examination instruments and adds value to the management and monitoring of very early RA patients. Certainly, such strategies may be useful for comparing the incremental benefit of DMARDs towards objective remission induction, but it is unclear whether it would alter long-term outcomes in clinical practice.

  1. Stoenoiu MS, et al. Ultrasound as imaging biomarker of early response to tocilizumab and methotrexate in early rheumatoid arthritis – TOVERA, a longitudinal study. POS0259, EULAR 2021 Virtual Congress, 2–5 June.


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