How Does Ultrasound Global OMERACT-EULAR Synovitis Score (GLOESS) for Rheumatoid Arthritis (RA) Activity Assessment Perform in Real-Life?

OBJECTIVE: This study aimed to assess the effectiveness of the Global OMERACT-EULAR Synovitis Score (GLOESS) of bilateral second to fifth metacarpophalangeal joints (MCP 2-5) in evaluating rheumatoid arthritis (RA) activity in a real-life setting. METHODS: This cross-sectional study included consecutive RA patients without hyperalgesia. Clinical data were extracted from electronic medical records. Evaluations were conducted on bilateral MCP 2-5 by two independent experts in musculoskeletal ultrasound (MSUS). Correlation between clinical and ultrasonographic parameters was analyzed, aiming to define a cutoff value for detecting disease activity. RESULTS: Sixty-nine patients were included. The mean DAS28-ESR was 4.3 (±1.4), and the median GLOESS was 7 (13). The correlation between GLOESS and DAS28 was moderate (r = .62; P < .05). A total GLOESS score of ≤3 and all joints with both GS and PD ≤1 showed good sensitivity and specificity for detecting disease activity (remission/low vs moderate/high, P = 0). CONCLUSION: In a real-life scenario, GLOESS for MCP 2-5 emerges as a valuable measure of RA activity. The optimal cutoff distinguishing remission/low from moderate/high disease activity was determined to be GLOESS ≤3, with all MCP joints exhibiting both GS and PD scores of ≤1.

Trivalent chromium versus baricitinib for rheumatoid arthritis treatment: first phase 2/3 randomized controlled trial, is trivalent chromium the upcoming immune-modulator?

BACKGROUND: Rheumatoid arthritis (RA) is a debilitating disease mainly treated by DMARDs. Baricitinib is one of the emerging DMARDs with strong anti-rheumatic effects but has serious side effects. Trivalent chromium (Cr III) is a natural element with anti-inflammatory properties. Trivalent chromium (Cr III) is introduced for the first time to study its effect and safety in treatment of RA patients and compared to those of baricitinib. METHODS: This is a phase 2/3 randomized controlled trial where RA patients were divided in a ratio of 2:1 according to the newly introduced medication either Cr (III) (group A) or baricitinib (group B). Patients attended three visits on day 0, after 3 weeks and 12 weeks, disease activity was scored. Hands ultrasound was done and reassessed. Side effects were monitored throughout the study. RESULTS: DAS28-CRP improved by 26.9% and 11.8% on third visit for Cr III and baricitinib, respectively (p = 0.001). DAS28-ESR improved by 25.6% and 7.74% on third visit for Cr III and baricitinib, respectively (p = < 0.001). ACR 50 was 18.8% for Cr III and 5.7% for baricitinib on second visit. ACR 70 was 25% for Cr III and 0% for baricitinib on third visit (P = < 0.001). Ultrasound GLOESS, SH, PDUS, joints effusions improved by 38.9%, 38.4%, 56.7% and 74.8% for Cr III, while by 10.5%, 3.75%, 59.6% and worsening of joints effusions happened with baricitinib on third visit. p = 0.022 and 0.002 between groups for GLOESS and SH improvement, respectively. CONCLUSIONS: Cr III has shown very promising fast clinical and sonographic results in treating RA patients which were surprisingly superior to baricitinib in most aspects. Furthermore, Cr III is potentially safe with evidently fewer side effects than baricitinib and other DMARDs, however, long-term safety is still not established. (IRB No.: 00012098- FWA No.: 00018699, Serial number: 040457) ClinicalTrials.gov ID: NCT05545020.

Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE.

OBJECTIVES: To investigate the dynamics of response of synovitis to IL-17A inhibition with secukinumab in patients with active PsA using Power Doppler ultrasound. METHODS: The randomized, placebo-controlled, Phase III ULTIMATE study enrolled PsA patients with active ultrasound synovitis and clinical synovitis and enthesitis having an inadequate response to conventional DMARDs and naïve to biologic DMARDs. Patients were randomly assigned to receive either weekly subcutaneous secukinumab (300 or 150 mg according to the severity of psoriasis) or placebo followed by 4-weekly dosing thereafter. The primary outcome was the mean change in the ultrasound Global EULAR and OMERACT Synovitis Score (GLOESS) from baseline to week 12. Key secondary endpoints included ACR 20 and 50 responses. RESULTS: Of the 166 patients enrolled, 97% completed 12 weeks of treatment (secukinumab, 99%; placebo, 95%). The primary end point was met, and the adjusted mean change in GLOESS was higher with secukinumab than placebo [-9 (0.9) vs -6 (0.9), difference (95% CI): -3 (-6, -1); one-sided P=0.004] at week 12. The difference in GLOESS between secukinumab and placebo was significant as early as one week after initiation of treatment. All key secondary endpoints were met. No new or unexpected safety findings were reported. CONCLUSION: This unique ultrasound study shows that apart from improving the signs and symptoms of PsA, IL-17A inhibition with secukinumab leads to a rapid and significant reduction of synovitis in PsA patients. TRIAL REGISTRATION: ClinicalTrials.gov; NCT02662985.

Comparison of composite indices with global synovitis score on ultrasound for detecting remission.

We aimed to compare composite indices with Ultrasound Global Synovitis Score (GLOESS) for remission in rheumatoid arthritis (RA). RA patients in remission according to the clinician were investigated with Disease Activity Score28 (DAS28), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and RAPID-3 (Routine Assessment of Patient Index Data 3). Ultrasonography was performed using the GLOESS scores. Patients in CDAI-remission had lower GLOESS (median (IQR), 5(3-9.75) vs 7(4-11.75), p = 0.048) with a similar trend in SDAI (5(3-9.25) vs 7(4-11.25), p = 0.064). This was not observed with DAS28-CRP and RAPID3. Our results show that CDAI is superior to other indices to assess remission in RA.

Reliability of ultrasound grading traditional score and new global OMERACT-EULAR score system (GLOESS): results from an inter- and intra-reading exercise by rheumatologists.

This study aims to test the reliability of ultrasound to graduate synovitis in static and video images, evaluating separately grayscale and power Doppler (PD), and combined. Thirteen trained rheumatologist ultrasonographers participated in two separate rounds reading 42 images, 15 static and 27 videos, of the 7-joint count [wrist, 2nd and 3rd metacarpophalangeal (MCP), 2nd and 3rd interphalangeal (IPP), 2nd and 5th metatarsophalangeal (MTP) joints]. The images were from six patients with rheumatoid arthritis, performed by one ultrasonographer. Synovitis definition was according to OMERACT. Scoring system in grayscale, PD separately, and combined (GLOESS-Global OMERACT-EULAR Score System) were reviewed before exercise. Reliability intra- and inter-reading was calculated with Cohen's kappa weighted, according to Landis and Koch. Kappa values for inter-reading were good to excellent. The minor kappa was for GLOESS in static images, and the highest was for the same scoring in videos (k 0.59 and 0.85, respectively). Excellent values were obtained for static PD in 5th MTP joint and for PD video in 2nd MTP joint. Results for GLOESS in general were good to moderate. Poor agreement was observed in 3rd MCP and 3rd IPP in all kinds of images. Intra-reading agreement were greater in grayscale and GLOESS in static images than in videos (k 0.86 vs. 0.77 and k 0.86 vs. 0.71, respectively), but PD was greater in videos than in static images (k 1.0 vs. 0.79). The reliability of the synovitis scoring through static images and videos is in general good to moderate when using grayscale and PD separately or combined.