POS0453 VALIDATION OF THE SIMPLIFIED DISEASE ACTIVITY INDEX (SDAI) WITH A QUICK QUANTITATIVE C-REACTIVE PROTEIN ASSAY (SDAI-Q) IN PATIENTS WITH RHEUMATOID ARTHRITIS: A NATIONAL, MULTICENTER STUDY
Authors: J. Schally, H. C. Brandt, J. Brandt-Juergens, G. R. Burmester, H. Haibel, H. Käding, K. Karberg, S. Lüders, B. Muche, M. Protopopov, V. Rios Rodriguez, M. Torgutalp, M. Verba, S. Zinke, D. Poddubnyy, F. Proft
Journal: Annals of the Rheumatic Diseases (2021)

Background: Therapeutic decisions in RA patients should be based on regular disease activity assessment using scores like the Simplified Disease Activity Index (SDAI) or the Clinical Disease Activity Index (CDAI) [1]. The CDAI has the benefit of being immediately available, while the SDAI encompasses with the C-reactive protein (CRP) an acute phase reactant and therefore is the recommended score for the use in clinical trials. However, CRP determination takes hours to days, thus hindering the treat-to-target concept using the SDAI. Quick quantitative CRP (qCRP) tests allow CRP measurement within a few minutes. Therefore, qCRP based SDAI (SDAI-Q) could combine the advantages of both scores. Objectives: To validate the SDAI-Q in a prospective, multicenter study of RA patients. Methods: The study was conducted in five centers in Berlin, Germany. Consecutive adult (≥ 18 years) RA patients were included. In addition to a rheumatological assessment, including patient reported outcomes, routine CRP was measured in the local labs. Additionally, a qCRP testing with the „QuikRead go instrument“ (Aidian Oy, Finland) was performed locally (measurement range 0.5 - 200 mg/l). Statistical analysis included descriptive statistics, cross tabulation and weighted Cohen´s kappa comparing disease activity categories, Bland-Altman plots and intraclass correlation coefficient (ICC) for CRP, qCRP, SDAI, SDAI-Q and CDAI. Results: In this study 100 RA patients were included (mean age: 60.9 years, mean disease duration: 11.4 years, 73.0% were female, 63.0% RF positive, 57.0% ACPA positive, 49.0% positive and 29% negative for both parameters). 75.0% were treated with csDMARD, 15% with tsDMARDs, 39.0% with bDMARDs and 40% with glucocorticoids (mean prednisolone equivalent: 5.4 mg prednisolone/d). Mean CRP and qCRP-levels were 6.97 and 7.89 mg/l, respectively (ICC 0.992; 95%CI: 0.987; 0.995). Comparing SDAI-Q and SDAI, all patients (100%) achieved the same disease activity status (Table 1A); weighted Cohen´s kappa was 1.000 (95%CI: 1.000; 1.000). ICC for SDAI-Q- and SDAI-values was 1.000 (95%CI: 1.000; 1.000). The agreement of SDAI-Q and SDAI is shown in a Bland-Altman plot (Figure 1). When comparing the CDAI with the SDAI-Q 93 patients (93%) were assigned to the same disease activity category (Table 1B); weighted Cohen´s kappa was 0.929 (95%CI: 0.878; 0.981). ICC for numerical values of SDAI-Q and CDAI was 0.989 (95%CI: 0.978; 0.994). Conclusion: SDAI-Q showed an absolute agreement with SDAI on the assignment to disease activity categories with the important advantage of time. With SDAI-Q, rheumatologists could base their clinical decision-making immediately on an index-based disease activity measurement by using a composite score considering acute phase reactants. Consequently, SDAI-Q can be integrated in clinical routine and clinical trials and could be implemented into the treat-to-target concept in RA patients. References: [1]Smolen JS, et al. Ann Rheum Dis. 2016 Jan; 75(1):3-15. Table 1. A) Disease activity categories by SDAI-Q vs. SDAI; B) Disease activity categories by SDAI-Q vs. CDAI A SDAI-Q (n = 100 ) Remission (≤ 3.3) Low Disease Activity (&gt; 3.3 and ≤ 11) Moderate Disease Activity (&gt; 11 and ≤ 26) High Disease Activity (&gt; 26) SDAI Remission (≤ 3.3) 28 (28.0% ) Low Disease Activity (&gt; 3.3 and ≤ 11) 31 (31.0% ) Moderate Disease Activity (&gt; 11 and ≤ 26) 35 (35.0% ) High Disease Activity (&gt; 26) 6 (6.0% ) B SDAI-Q (n = 100 ) Remission (≤ 3.3) Low Disease Activity (&gt; 3.3 and ≤ 11) Moderate Disease Activity (&gt; 11 and ≤ 26) High Disease Activity (&gt; 26) CDAI Remission (≤ 2.8) 26 (26.0% ) Low Disease Activity (&gt; 2.8 and ≤ 10) 2 (2.0% ) 28 (28.0% ) 2 (2.0% ) Moderate Disease Activity (&gt; 10 and ≤ 22) 3 (3.0% ) 33 (33.0% ) High Disease Activity (&gt; 22) 6 (6.0% ) Fields highlighted in red indicate that disease activity categories do not match. SDAI = Simplified Disease Activity Index; SDAI-Q = SDAI calculated with a quick quantitative CRP assay; CDAI = Clinical Disease Activity Index. Figure 1. Bland-Altman plot for SDAI and SDAI-Q Acknowledgements The authors would like to deeply thank Braun T, Doerwald C, Deter N, Höppner C, Lackinger J, Lorenz C, Lunkwitz K, Mandt B, Sron S and Zernicke J for their practical support and coordinating the study. Funding statement: The AQUA study was supported by an unrestricted research grant from Novartis. Testing kits were provided free of charge from Aidian Oy, Finland. Disclosure of Interests: None declared