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Background: Remission in rheumatoid arthritis (RA) is a state with an absence of disease activity. Remission at 6 months has been shown to predict future good outcomes such as arresting radiographic progression and better functional status at 12 and 24 months. ACR EULAR has endorsed Boolean2.0 in the revised remission criteria in 2022. Comparison of performance of various commonly used remission criteria (Disease Activity Score 28 (DAS28 ESR), Disease Activity Score 28 CRP (DAS28 CRP), Simple Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Boolean, Boolean2.0 and BooleanX in patients with RA from India and its association to Patient Related Outcomes (PROs) is not studied. In this study, we compare the various remission criteria in patients with RA from India and explore its association with PROs. Objectives: To compare the performance of various remission criteria in patients with RA, validate the newly endorsed Boolean-based remission criteria, and explore its relationship with PROs in RA. Methods: In this prospective hospital-based study, we enrolled patients with RA attending our Rheumatology Clinic at Jodhpur, India after Ethics Committee approval. Patients were assessed clinically after informed written consent and different ACR EULAR disease activity scores (DAS28, SDAI, CDAI, Boolean, Boolean2.0, and BooleanX) and various PROs Visual Analogue Scale (VAS) for pain, PROMIS® fatigue score, Indian Health Assessment Questionnaire (IHAQ) disability index, Patient Health Questionnaire (PHQ-9) depression score, Pittsburgh Sleep Quality Index (PSQI) and Rheumatoid Arthritis Impact of Disease (RAID) scores were obtained at enrollment and 6 months. Agreement between Boolean-based and index-based criteria were analyzed using kappa analysis at enrollment and 6 months. Bivariate correlation analysis and binary logistic regression analysis were done to correlate between various remission criteria and PROs at enrollment and 6 months. Results: Out of 155 participants, 83.87% were females with a median age of 46.7±12.1 years. Out of these, 32 patients (20.64%) belonged to early RA while 123 (79.35%) patients had established RA. At enrolment, 11.61% (n = 18) were on biologicals, 29.1% (n = 45) on methotrexate, and 59.35% (n = 92) on combination Disease-modifying Antirheumatic Drugs (DMARDs). The proportion of patients in remission at 6 months using DAS28-ESR was 81.30%, DAS28-CRP was 76.10%, SDAI was 67.10%, CDAI was 69.60%, Boolean was 40.20% and Boolean2.0 was 65.10% (Figure 1). In our study, all remission criteria showed agreement between each other. Boolean2.0 showed more remission rates compared to Boolean1.0 and a substantial level of agreement between SDAI and CDAI at 6 months (Table 1). Our study showed a significant reduction in DAS28-ESR, DAS28-CRP, SDAI, and CDAI at 6 months and similarly a significant reduction in VAS, PROMIS® fatigue score, IHAQ, PSQI, PHQ-9, and RAID at 6 months following starting treatment. However, none of the PROs revealed any correlation with remission criteria at enrollment and 6 months following initiation of treatment. Conclusion: This study provides evidence of external validation of the newly proposed modification of the Boolean ACR/EULAR remission criteria. Our results replicate the findings that a Boolean definition using 2 cm as the threshold for patient global assessment of disease activity (Boolean2.0) yields better agreement than Boolean1.0. With the validation of Boolean2.0 in our settings, our data support the revised ACR/EULAR remission criteria as a target in clinical practice in India. None of the remission criteria can replace PROs and thus, PROs should be measured separately in assessing treatment targets. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests: None declared.
Banjari et al. (Sat,) studied this question.
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