ABSTRACT
To analyze the clinical characteristics of patients with antisynthetase syndrome (ASS) and positive anti-Ro52 antibody. The clinical data of 203 ASS patients admitted to the First Affiliated Hospital of Zhengzhou University from 2017 to 2020 were analyzed retrospectively. Demographics, clinical manifestations, laboratory results, treatment and outcome were collected including data of 18 patients with rapidly progressive interstitial lung disease (RP-ILD). In total, the majority were women (148,72.9%). The average onset age was (51.9±13.3) years. There were 163 (80.3%) patients with positive anti-Ro52 antibody. The positivity in women (77.3% vs. 55.0%, P=0.004) was higher, and the median time from disease onset to diagnosis [4.5 (2.0, 24.0) months vs. 2.0 (1.0, 12.0) months, P=0.024] was longer in patients with positive anti-Ro52 antibody than those negative. Compared with negative patients, patients with positive anti-Ro52 antibody had a higher incidence of interstitial lung disease (ILD) (96.9% vs. 65.0%, P<0.001), arthritis (33.7% vs. 17.5%, P=0.046), and arthralgia (39.3% vs. 20.0%, P=0.022). Higher rate of positve antinuclear antibody (ANA) (85.3% vs. 55.0%, P<0.001), lower rate of positive anti-Jo-1 antibody (32.5% vs. 50.0%, P=0.039), lower albumin level [(34.6±5.2) g/L vs. (37.3±4.7) g/L, P=0.004] and lower lymphocyte counts [(1.4±0.8) ×10 9/L vs. (1.8±0.8) ×10 9/L, P=0.014] were more common in patients with positive anti-Ro52 antibody. The presence of anti-Ro52 antibody is associated with a particular phenotype of ASS, leading to common ILD, involvement of joints, high ANA positivity, low albumin and low lymphocyte counts.
ABSTRACT
Objective To evaluate the efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ IgG: Fc fusion protein for injection (rhTNFR: Fc) treatment in Chinese patients with early rheumatoid arthritis (ERA) and active spondyloarthritis. Methods This was a large-scale, multicenter, open-label, phase Ⅳclinical observational study. The dosage of rhTNFR: Fc was 50 mg per week, combined or not combined with other drugs. The primary endpoint of efficacy included the proportion of patients with low disease activity [simplified disease activity index (SDAI)≤11] at 3 month and 6 month. Secondary endpoint variables included clinical disease activity index (CDAI), disease activity score 28 based on C-reactive protein (DAS28-CRP) and health assessment questionnaire(HAQ). The primary endpoint of SpA was the ankylosing spondylitis disease activity score (ASDAS-CRP) at month 3. The secondary endpoints were the proportion of subjects achieving ASDAS<1.3 and ASDAS<2.1, Bath AS functional index (BASFI) and CRP. All subjects in the study were evaluated for safety. T test, χ2 test and rank sum test were used for satistical analysis. Results One thousand two hundred and seventy subjects with ERA were studied. The difference between the baseline and month 3 after treatment in SDAI, CDAI, DAS28-CRP were 26 ±16, 23 ±15, 1.86 ± 1.01 respectively (P<0.01). The above parameters 6 months after treatment were similar to those at 3 months after treatment, which demonstrated the persistence of drug efficacy. Two thousand three hundred and twenty eight subjects of SpA were studied. The difference between the baseline and 3 months after treatment in ASDAS, BASFI was 2.6 ±1.7, 3.4 ±3.8 respectively (t=73 .54, t=42 .36, P<0.01). The overall incidence of adverse events was 8.03%(289/3 598), including the common adverse events such as injection site reactions, skin rash and elevated liver enzyme levels. Adverse events were improved after proper treatment, without severe infections and tumor. These data confirmed that the overall safety of rhTNFR: Fc was good. Conclusion The study confirms that rhTNFR: Fc is effective for the treatment of ERA and SpA, and it is safe and well-tolerated.