Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial.

BACKGROUND: Biosimilars provide an opportunity to address unmet medical need by expanding access to biological treatments. This study aimed to show equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles of a proposed tocilizumab biosimilar BAT1806/BIIB800, to reference tocilizumab, in participants with rheumatoid arthritis with an inadequate response to methotrexate. METHODS: This phase 3, multicentre, randomised, double-blind, active-controlled, equivalence study comprised a 24-week initial treatment period (results reported here) and a 24-week secondary treatment period. Participants were recruited at 54 centres across five countries (China, Ukraine, Poland, Georgia, and Bulgaria). Patients with active rheumatoid arthritis with an inadequate response to methotrexate were randomly assigned (1:1:2) to receive reference tocilizumab up to week 48, or reference tocilizumab up to week 24 followed by BAT1806/BIIB800 up to week 48 (the two reference tocilizumab groups were analysed as a single group in this analysis), or BAT1806/BIIB800 up to week 48 (the BAT1806/BIIB800 group), administered by intravenous infusion once every 4 weeks at a starting dose of 8 mg/kg. The primary endpoint was the proportion of participants who had a 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 (for the European Medicines Agency [EMA]) or week 24 (for the US Food and Drug Administration [FDA] and China National Medical Products Administration [NMPA]) using prespecified equivalence margins (95% CI -14·5 to +14·5 [EMA], 90% CI -12·0 to +15·0 [FDA], and 95% CI -13·6 to +13·6 [NMPA]). The International Council for Harmonisation E9(R1) estimand framework, with strategies for addressing intercurrent events, was implemented for the efficacy evaluations with expected differences as per the predefined equivalence margins. This trial is registered at ClinicalTrials.gov (NCT03830203) and EudraCT (2018-002202-31), and is closed to new participants. FINDINGS: Between Dec 19, 2018, and Jan 5, 2021, we randomly assigned 621 participants: 309 to the reference tocilizumab group and 312 to the BAT1806/BIIB800 group. The mean age was 50·5 years (SD 12·0), 534 (86%) were women, 87 (14%) were men, and 368 (59%) were White. For the primary estimands, estimated ACR20 response rates were 64·8% in the reference tocilizumab group and 69·0% in the BAT1806/BIIB800 group (treatment difference 4·1% [95% CI -3·6 to 11·9]) at week 12, and 67·9% in the reference tocilizumab group and 69·9% in the BAT1806/BIIB800 group (treatment difference 1·9% [90% CI -4·0 to 7·9; 95% CI -5·2 to 9·1]) at week 24. All confidence intervals were contained within the predefined equivalence margins. Comparable pharmacokinetic and immunogenicity profiles were observed for the reference tocilizumab and BAT1806/BIIB800 groups. Adverse events were reported by 201 (65%) participants in the reference tocilizumab group and 206 (66%) in the BAT1806/BIIB800 group; 196 (63%) participants in the reference tocilizumab group and 201 (64%) participants in the BAT1806/BIIB800 group reported a treatment-emergent adverse event. Five participants had a fatal event (reference tocilizumab n=1; BAT1806/BIIB800 n=4). INTERPRETATION: BAT1806/BIIB800 showed equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles as reference tocilizumab. FUNDING: Bio-Thera Solutions and Biogen.

Radial growth responses of three coniferous species to climate change on the southern slope of Funiu Mountains, China.

Funiu Mountains are located in a transition region between warm temperate zone and northern subtropical region, where a variety of plant species are distributed with sensitive response to climate change. Their response characteristics to climate change are still unclear. We developed the basal area increment (BAI) index chronologies of Pinus tabuliformis, P. armandii, and P. massoniana in the Funiu Mountains to examine their growth trend and their sensitivity to climatic change. The results showed that the BAI chronologies gave a clue that the three conife-rous species had similar radial growth rate. The large Gleichlufigkeit (GLK) indices among the three BAI chronologies also indicated that the three species had a similar growth trend. Results of correlation analysis showed that the three species also had similar response to climatic change to a certain extent. Radial growth of all the three species was significantly positively correlated with the total monthly precipitation in December of previous year and June of the current year, but negatively correlated with the precipitation in September and the mean monthly temperature in June of the current year. There were some differences in the responses of the three coniferous to climate change. P. massoniana had a significant negative correlation with the mean temperature in March, and a significant positive correlation with the precipitation in March, while P. armandii and P. massoniana were affected negatively by the maximum temperature in August. Results of the moving correlation analysis showed that the three coniferous species had some similar sensitivity to climate change. Their positive responses to precipitation in previous December consistently increased, as well as the negative correlation with precipitation in current September. As to P. masso-niana, they had a relatively stronger climatic sensitivity and higher stability than the other two species. It would be more suitable for P. massoniana trees on the southern slope of the Funiu Mountains under global warming.

QRISK3-based analysis of cardiovascular risk factors in patients with long-term but well-controlled systemic lupus erythematosus.

Systemic lupus erythematosus (SLE) is a multisystem inflammatory disease of unknown etiology. Corticosteroids and immunosuppressive agents are the principal forms of treatment for this condition. While cardiovascular disease (CVD) is known to be a major cause of death in patients with SLE, there has been no improvement over the last few decades with regard to diagnosis, treatment, or prognosis. The QRISK3 algorithm is a new algorithm that includes SLE-related risk factors; this tool can predict the risk of CVD over a ten-year period. In this study, involving 180 patients, we compared the performance of the Framingham risk score, the recalibrated risk prediction SCORE, and QRISK3 for the assessment of CVD in patients with a long course of disease and low disease activity. Then, we used a more efficient algorithm, QRISK3 to identify the risk factors for CVD. This was a prospective and cross-sectional study involving 116 patients. All patients fulfilled the ACR criteria. The systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) is widely used to assess disease activity in SLE patients; patients with a SLEDAI-2K less than or equal to 4 are considered to be stable. Thus, we defined well-controlled patients as those with a SLEDAI-2K score less than or equal to 4. The dose of glucocorticoid (GC) that patients received was less or equal to 10 mg per day. We recorded and assessed a range of traditional risk factors, current treatments, comorbidities, data at the time of onset, and SLE-related evaluations. The QRISK3 score, and the relative risk (RR) that this score defined, were used to estimate the risk of CVD in patients with SLE. According to these relative risks, the patients were divided into low- (n=28), intermediate- (n=46), and high-relative risk (n=31) groups for subgroup analysis. Of the 116 patients enrolled, 105 were eligible to be assessed for the risk of CVD. By univariate analyses, the RR was significantly related with age at the time of enrolment (p<0.001), age at onset (p<0.001), resting heart rate (RHR) (p<0.001), present dose of GCs (p<0.001), present SLEDAI-2K (p=0.015), aerobic exercise (p<0.001), initial SLEDAI-2K (p<0.001), and initial dose of GCs (p=0.048). In the multiple linear regression model, the RR of CVD was significantly correlated with the initial SLEDAI-2K score (ß=2.112, p<0.001), initial dose of GCs (ß=-0.009, p=0.041), resting heart rate (ß=0.241, p=0.003) and age at onset (ß=-0.208, p=0.004). Pearson's correlation showed that RHR was significantly associated with aerobic exercise (r=-0.322, p=0.001). Subgroup analysis further identified a positive correlation between the history of nephritis, metabolic syndrome (MetS), aerobic exercise, present dose of GCs, and the RR of CVD. Patients with long-term but well-controlled SLE had a high relative risk of CVD and that this was associated with resting heart rate (P=0.003), history of lupus nephritis (P<0.001), initial SLEDAI-2K score (P<0.001), and metabolic syndrome (P=0.017). However, age at onset (P<0.001), use of hydroxychloroquine (P=0.30) and Mycophenolate mofetil (P=0.01), and the initial dose of glucocorticoid (P=0.049), were protective factors. Younger SLE patients had a significantly higher relative risk of CVD than older patients (p<0.001). QRISK3 detected more SLE patients at high risk of CVD when compared to the Framingham and recalibrate SCORE. To reduce the risk of CVD in SLE patients, measures should be taken both during the initial stages of disease and for long-term management.

Intravenous immunoglobulin for interstitial lung diseases of anti-melanoma differentiation-associated gene 5-positive dermatomyositis.

OBJECTIVE: Rapidly progressive interstitial lung disease (RP-ILD) in DM patients positive for anti-melanoma differentiation-associated gene 5 (anti-MDA5) autoantibody (MDA5-DM) often have a poor prognosis, frequently fatal. As there is a scarcity of data regarding the effect of intravenous immunoglobulin (IVIG) on RP-ILD in MDA5-DM patients (MDA5-RPILD), we conducted this study to determine the efficacy of a IVIG add-on initial treatment. METHODS: Patients with newly-onset MDA5-RPILD from September 2018 to June 2020 were retrospectively reviewed for 6 months in the First Affiliated Hospital of Zhengzhou University. They were divided into two groups: IVIG and non-IVIG groups. The major measurement of treatment outcome was the difference in the mortality in 3-month and 6-month between two group patients. Other relevant indicators were also recorded, including the incidence of infection, the dosages of GCs, the remission rate and the variables in laboratory data. RESULTS: The IVIG group (n = 31) showed significantly lower 6-month mortality rate than the non-IVIG group (n = 17) (22.6% vs 52.9%; P =0.033). The IVIG group patients had a higher remission rate at 3 months (71.0% vs 41.2%; P =0.044). Gradual reduction was observed in the first 3 months with regard to the titre of anti-MDA5 autoantibody, the serum level of ferritin and the ground glass opacification GGO scores. CONCLUSION: IVIG adjunct therapy is a very effective first-line treatment for patients with MDA5-RPILD. IVIG may increase the survival and remission rate by lowering ferritin concentration, anti-MDA5 titre and GGO score.

Treatment satisfaction with rheumatoid arthritis in patients with different disease severity and financial burden: A subgroup analysis of a nationwide survey in China.

BACKGROUND: Despite the recent advances in treatments for rheumatoid arthritis (RA), there are still unmet needs in disease outcomes. This study aimed to analyze the satisfaction with drug therapies for RA according to the levels of disease severity (patient-assessed) and proportions of treatment cost to household income. METHODS: This was a subgroup study of a cross-sectional study in patients with RA and their physicians. The patients were subdivided into different subgroups based on their self-assessed severity of RA and on the proportions of treatment cost to household income (<10%, 10-30%, 31-50%, and >50%). The Treatment Satisfaction Questionnaire for Medication version II was used to assess patients' treatment satisfaction. RESULTS: When considering all medications, effectiveness, convenience, and global satisfaction scores were lower in the severe and moderate RA subgroups than those in the mild and extremely mild RA subgroups (all P < 0.001). Effectiveness, side effects, and convenience scores were higher in the <10% subgroup compared to those in the >50% subgroup (all P < 0.05). Global satisfaction score was higher in the <10% subgroup than that in the 31% to 50% subgroup (F = 13.183, P = 0.004). For biological disease-modifying anti-rheumatic drugs, effectiveness and convenience scores were lower in the severe RA subgroup than those in the extremely mild RA subgroup (both P < 0.05). Convenience score was higher in the <10% subgroup compared to that in the 31% to 50% and >50% subgroups (F = 12.646, P = 0.005). Global satisfaction score was higher in the <10% subgroup than that in the 31% to 50% subgroup (F = 8.794, P = 0.032). CONCLUSION: Higher disease severity and higher financial burden were associated with lower patient satisfaction.

Diagnosing relapsing polychondritis remains a common challenge: experience from a Chinese retrospective cohort.

OBJECTIVE: The diagnosis of relapsing polychondritis (RP) is often mistaken or delayed. In this retrospective cohort, we aimed to unveil the causes responsible for such phenomenon, to determine the associated factors, and to compare diagnosis in clinical settings with the current diagnostic criteria. METHOD: Eighty-seven RP patients followed-up by rheumatologists from January 1, 2008, to October 31, 2018, were retrospectively analyzed. RESULTS: A total of 50 male and 37 female patients were included with a mean age of 45.9 ± 14.5 years. Ninety-three percent were initially admitted by non-rheumatologic specialists .Twenty-eight percent were correctly diagnosed, while 72% were misdiagnosed at the first visits, all by non-rheumatologic specialists. Patients admitted by non-rheumatologic specialists had increased odds of misdiagnosis (odds ratio [OR] = 1.3, 95% confidence interval [95% CI] 1.1-1.7, P = 0.000). Fifty-seven (65.5%) patients did not meet with Michet or Damiani criteria, with 16 (18.4%) patients diagnosed as partial RP and 41( 47.1%) patients diagnosed as limited RP. CONCLUSIONS: Incorrect and delayed diagnosis of RP is common in our cohort, and insufficient awareness of the disease in non-rheumatologic specialists at least partially contributes to this. It is imperative to revise the current criteria for early diagnosis.Key Points• Diagnosing relapsing polychondritis (RP) in early stage remains challenging after all these years, especially among non-rheumatologic specialists, indicating the importance of teaching non-rheumatologic specialists to improve their understanding of this rare disease.• Many RP patients did not fully meet with the current criteria, suggesting that revision of the current criteria is imperative for early diagnosis of this rare disease.

Predictive factors and prognosis of macrophage activation syndrome associated with adult-onset Still's disease.

OBJECTIVES: To summarise the clinical data of adult-onset Still's disease (AOSD) patients and analyse their clinical manifestations, predictors for the formation and prognosis of macrophage activation syndrome (MAS). METHODS: A retrospective analysis was performed on the clinical data of 182 AOSD hospitalised patients from the Department of Rheumatology of the First Affiliated Hospital of Zhengzhou University, China from January 2012 to August 2018, including 11 patients with pathogenesis of MAS. RESULTS: Compared with the patients without MAS, the patients with MAS had a higher incidence of splenomegaly and pericarditis at the initial diagnosis of AOSD. The number of platelets (PLT) and the concentration of fibrinogen (FIB), D-Dimer and ferritin were significantly higher in AOSD-MAS patients. Multivariate regression analysis showed that splenomegaly (OR: 5.748, 95% CI: 1.378-23.984, p=0.016), pericarditis (OR: 6.492, 95% CI: 1.43-29.461, p=0.015), and ferritin >2000 µg/L (OR: 4.715, 95% CI: 1.12-19.86, p=0.035) were risk factors for MAS. Survival analysis indicated that the mortality of AOSD-MAS patients was significantly higher than patients without MAS. CONCLUSIONS: Splenomegaly, pericarditis and elevated ferritin concentration are risk factors for MAS formation in AOSD patients. MAS resulted in a significant decrease in the survival rate of the AOSD patients.

Intussusception merged with systemic lupus erythematosus: one case report and retrospective analysis.

Intussusception is characterized by one segment of the gastrointestinal tract telescoping into the lumen of the adjacent segment; it is rarely reported in systemic lupus erythematosus (SLE), and the condition can be threatening. Only four cases of intussusception with SLE have been reported in literature. Here, we describe a new case of a patient with ileocecal intussusception merged with SLE, who was diagnosed using abdominal computed tomography and successfully treated with high-dose intravenous immunoglobulin (IVIG) and pulse methylprednisolone.

The Efficacy of Imrecoxib and Celecoxib in Axial Spondyloarthritis and Their Influence on Serum Dickopff-Related Protein 1 (DKK-1) Levels.

BACKGROUND To observe and demonstrate therapeutic effects and side effects of two selective COX-2 inhibitors, imrecoxib and celecoxib, on patients with axial spondyloarthritis (axSpA) and observe the correlation between imaging scores and serum DKK-1 levels. MATERIAL AND METHODS Sixty patients with axSpA were randomly assigned to receive 200 mg imrecoxib or 200 mg celecoxib twice daily. Fifty-one patients who completed follow-up were included in the study. At baseline, week 4, and week 12, the clinical parameters, inflammatory markers (ESR, CRP), and adverse reactions were recorded. Serum DKK-1 levels were investigated by enzyme-linked immunosorbent assay. Radiographic scores were calculated by sacroiliac joint SPARCC (Spondyloarthritis Research Consortium of Canada) score method at baseline serum DKK-1 levels and week 12. RESULTS Patients in the imrecoxib group (n=25) and patients in the celecoxib group (n=26) were improved at week 4. At week 12, all clinical parameters and inflammatory markers were improved in the two groups and the differences was not statistically significant. Serum DKK-1 levels were decreased and the differences were not statistically significant. Serum DKK-1 levels in patients in the imrecoxib group at baseline were negatively correlated with all study parameters, while those in the celecoxib group had correlations with BASFI (r=-0.048, p=0.027) and Schober test (r=0.437, p=0.048), without any correlation with other clinical parameters or inflammatory markers. CONCLUSIONS Patients experienced significant improvement in disease activity, functional parameters, and inflammatory markers when treated with selective COX-2 inhibitors for 12 weeks, and the efficacy of imrecoxib was not inferior to celecoxib. Selective COX-2 inhibitors imrecoxib and celecoxib had no obvious effects on serum DKK-1 levels.

Expression of autophagy related genes mTOR, Becline-1, LC3 and p62 in the peripheral blood mononuclear cells of systemic lupus erythematosus.

To determine the expression of mTOR, Becline-1, LC3 and p62 in the peripheral blood mononuclear cells (PBMCs) of systemic lupus erythematosus (SLE) and assess their relationship with disease activity and immunologic features. The expression of mTOR, Becline-1, LC3 and p62 was detected by RT-PCR in 81 SLE subjects and 86 age- and sex-matched healthy controls. Data regarding demographics and clinical parameters were collected. Disease activity of SLE was evaluated according to the SLE Disease Activity Index (SLEDAI) score. Independent sample t-test was used to analyze the expression of mTOR, Becline-1, LC3, and p62 in the two groups. Pearson's or Spearman's correlation was performed to analyze their relationship with disease activity and immunologic features. The mean levels of Becline-1, LC3 and p62 mRNA were significantly higher in SLE patients than the controls (9.96×10-4 vs 7.38×10-4 for Becline-1 with P<0.001; 4.04×10-5 vs 2.62×10-5 for LC3 with P<0.001; 9.51×10-4 vs 7.59×10-4 for p62 with P=0.008). However, the levels of mTOR mRNA in SLE patients were not significantly different from that in controls. Correlation analysis showed that Becline-1, LC3 and p62 mRNA levels correlated positively with SLEDAI, IgG and ds-DNA, negatively with C3. Our results suggested that autophagosomes formation were activated and their degradation were blocked in SLE. Moreover, the maintenance of autophagy balance can improve disease activity and immune disorders in SLE patients.

ANCA positive relapsing polychondritis, Graves disease, and suspected moyamoya disease: A case report.

RATIOINALE: Relapsing polychondritis (RP) is a rare and heterogeneous disease complex of unknown origin which basically affects cartilaginous structures, 40% of which accompanied by rheumatic, hematologic, and endocrine disease. Among them, vasculitis is the most common accompanying type and usually presented with positive antineutrophilic cytoplasmic antibody (ANCA). The presence of ANCA could be primary or drug-induced like propylthiouracil (PTU). Central involvement of RP is very rare, and there is almost no report of cerebral vasculopathy manifested as moyamoya. PATIENT CONCERNS: A 26-year-old woman complained about recurrent fever, auricular chondritis, ocular inflammation, and arthritis. She had an 8-year drug intake of PTU for Graves disease. Myeloperoxidase antineutrophilc cytoplasmic antibodies (MPO-ANCA) were found positive. Magnetic resonance angiography (MRA) detected multiple intracranial vasculopathy which we highly suspected it as moyamoya disease. DIAGNOSES: Relapsing polychondritis, Graves disease and suspected moyamoya disease were clinically diagnosed. INTERVENTIONS AND OUTCOMES: In case of possible PTU-induced vasculitis and the aggravation of vasculopathy, PTU was replaced by Iodine-131 (I) therapy. Induction treatment included oral prednisone 30 mg daily and oral cyclophosphamide 100 mg daily. Symptoms rapidly relieved before discharge. Inflammation markers were normal and MPO-ANCA decreased in 3 weeks after admission. Prednisone was gradually tapered to 7.5 mg daily and at month 10 azathioprine was continued for maintenance. LESSONS: RP can overlap with Graves disease and moyamoya disease; comprehensive tests should be performed when admission. When relapsing polychondritis is accompanied with Graves disease, especially when ANCA is positive, PTU should be avoided.

Levels of serum procalcitonin and C-reactive protein for evaluating pulmonary bacterial infection in patients with lupus erythematosus.

The severity of systemic lupus erythematosus (SLE) patients with pulmonary bacterial infection varies widely. We investigated the significance of procalcitonin (PCT) and C-reactive protein (CRP) in evaluating the severity of pulmonary infection in SLE patients. This retrospective study contained a total of 117 patients (107 women and 10 men) with SLE from January 2010 to June 2011. Serum levels of PCT and CRP were measured by enzyme-linked immunosorbent assay. The severity of pulmonary bacterial infection (PBI) was evaluated using the pneumonia severity index (PSI). SLE patients with PBI, particularly those with bacterial isolates, had significantly higher levels of serum PCT and CRP than those without PBI. Serum PCT and CRP were not associated with SLE disease activity, but positively with the values of PSI in active SLE patients with PBI. Serum levels of PCT and CRP may be additional biomarkers in evaluating the severity of PBI in lupus patients.

High prevalence of hypovitaminosis D of patients with autoimmune rheumatic diseases in China.

We aimed to determine the prevalence of hypovitaminosis D in patients with autoimmune rheumatic diseases (ARDs) in China and its association with demographic characteristics of the patients. We recruited 384 patients in this cross-sectional study including 121 cases of systemic lupus erythematosus (SLE), 131 rheumatoid arthritis (RA), 102 spondyloarthritis (SpA) and 30 other ARDs. For each patient, demographic information was collected and serum concentration of 25OHD3 was measured by electrochemiluminescence immunoassay (ECLIA). The multivariate logistic regression model was used to investigate the association between vitamin D deficiency and patient characteristics. The mean serum vitamin D level of the 384 patients was 18.91 (8.12) ng/mL, and the median age was 37.33 (12.01) yrs. Among these patients, 222 (57.81%) and 127 (33.07%) were found to be vitamin D deficiency and insufficiency, respectively. From the disease perspective, the percentages of insufficiency and deficiency were as follow: 97.52% and 84.30% in SLE, 87.02% and 48.85% in RA, 88.24% and 40.20% in SpA, 90.89% and 57.81% in other ARDs patients. The causative factors for vitamin D deficiency included SLE per se (OR 12.54, P < 0.001) and high body mass index (BMI) (OR 1.88, P < 0.001). However, the seniors were less likely to have vitamin D deficiency (OR 0.95, P = 0.005). No correlation was disclosed between vitamin D deficiency and gender or disease duration. Hypovitaminosis D is highly prevalent among autoimmune rheumatic diseases population in China. The SLE per se and the obesity are the risk factors for vitamin D deficiency. Clinicians are advised to supplement vitamin D in these patients.

[The short-term efficacy and safety of methotrexate plus low dose prednisone in patients with rheumatoid arthritis].

OBJECTIVE: To evaluate the clinical efficacy and safety of methotrexate (MTX) plus low dose glucocorticoid in the treatment of rheumatoid arthritis (RA) from the "target control" point of view. METHODS: Patients diagnosed as RA according to American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 classification criteria were enrolled. All of the patients were prescribed with 15 mg/week MTX, 5 mg/week folic acid and prednisone (not exceeding 10 mg/day) orally. At week 0, 4, 12, disease activity and clinical efficacy were recorded. Co-primary assessment criterion was disease activity score (DAS28)-based on C-reactive protein (CRP). Secondary assessment criteria included EULAR response criteria, ACR response criteria, simplified disease activity index (SDAI) , clinical disease activity index (CDAI) . The tolerability and toxicity of MTX was recorded at week 4, 12. All patients were evaluated for the occurrence of adverse drug reactions associated with prednisone at week 12. RESULTS: A total of 76 patients were enrolled in the study. At week 4 and 12, 68 and 65 patients completed regular follow-up respectively. At week 12, there were 30 (46.2%), 9 (13.8%), 26 (40.0%) patients who met DAS28-CRP remission, low disease activity, middle and high disease activity criterion respectively. Three of nine patients who grouped in low disease activity after therapy were early or intermediate patients and didn't reach the target. Thus 36(55.4%) patients met the standard of target control. The percentage of patients who met the criteria of EULAR good response, the ACR criteria for 20% improvement (ACR20) , the ACR criteria for 50% improvement (ACR50), the ACR criteria for 70% improvement (ACR70) were 29.2%, 75.4%, 69.2%, 64.6%, respectively. The proportion of patients meeting the standard of treat to target using SDAI and CDAI were 76.9%, 58.5% respectively. The rate of liver injury, abdominal pain, abdominal distention and acid reflux, nausea were 11.8%, 4.4%, 4.4%, 2.9% respectively at week 4. At week 12, 4.6% of patients reported abdominal distention. There was only one patient (1.5%) each who complained of abdominal pain, nausea, loss of hair, varicella zoster virus infection and pulmonary infection at week 12. No serious adverse event was observed during the study. CONCLUSIONS: Based on the view of "target control", drug efficacy and safety, MTX plus low dose prednisone is still a useful therapeutic regimen for RA at present.

[Incidence of metabolic syndrome in systemic lupus erythematosus and its influence by glucocorticoids].

OBJECTIVE: To investigate the incidence and correlative factors of metabolic syndrome (MS) in patients with systemic lupus erythematosus (SLE). METHODS: A total of 116 SLE patients and 115 controls were enrolled into the study. The incidence of MS, SLE disease activity index (SLEDAI) of patients with SLE combined with MS (MS-SLE) and patients without MS (n-MS-SLE), lupus characteristics, cumulative glucocorticoids, administration dose of glucocorticoids and hydroxychloroquine were compared between SLE group and the control group. RESULTS: The incidence of MS of SLE group was obviously higher than that of the control (34.48% vs 14.78%, P < 0.05). The ratios of patients with lower HDL-C, higher TG and higher blood pressure in SLE group (50.86%, 56.03%, 46.55%) were higher than those in the controls (34.78%, 16.52%, 20.00%, all P < 0.05). MS-SLE group had significantly higher mean waist circumference, BMI, systolic blood pressure and diastolic blood pressure and lower HDL-C than n-MS-SLE group (all P < 0.05). No significant difference was found regarding duration of disease, renal involvement, ESR, C-reactive protein,high-sensitivity C-reactive protein, SLEDAI, cumulative and current glucocorticoids use in MS-SLE group and n-MS-SLE group. The ratio of patients taking hydroxychloroquine in n-MS-SLE group was higher than that of MS-SLE group (46.05% vs 15.00%, P < 0.05). CONCLUSIONS: Patients with SLE has a higher incidence rate of MS. Hydroxychloroquine may reduce their MS incidence.