Outcomes
treatment-emergent adverse events, RA, fatigue, pain
REMISSION
The primary outcomes were the proportion of patients and time to achieving sustained LDA (CDAI ≤ 10), for 2 consecutive assessments conducted approximately 3 months apart over a 1-year observation period.Secondary outcomes included (i) the proportion of patients and the time to achieve CDAI LDA (≤ 10) and remission (≤ 2.8), SDAI remission (≤ 3.3), DAS28-CRP LDA (< 3.2) and remission (< 2.6), RAPID 3 LDA (≤ 6) and remission (≤ 3), HAQ-DI MCID (Δ ≥ 0.22) at months 3, 6, 9, 12; (ii) the change in CDAI, SDAI, DAS28-CRP, HAQ-DI, RAPID3, TJC28, SJC28, pain, and fatigue from baseline to months 3, 6, 9, 12; (iii) number of changes in RA treatment; and (iv) the incidence of treatment-emergent adverse events (TEAEs), including serious (SAEs) and non-serious AEs.