1.ReABLE study on the efficacy and long-term safety of recombinant human tumor necrosis factor-α receptor Ⅱ IgG Fc fusion protein with methotrexate in active rheumatoid arthritis
Qingjun WU ; Zhuoli ZHANG ; Zhenbin LI ; Dong XU ; Guangtao LI ; Lifen GENG ; Mengtao LI ; Yu WANG ; Jianjun ZHU ; Yanjie HAO ; Nailing HUI ; Jing YANG ; Xiaoqing CUI ; Xiaogang ZHANG ; Yan ZHAO
Chinese Journal of Rheumatology 2011;15(9):600-603
ObjectiveTo evaluate the clinical and radiographic efficacy and safety of the combination of recombinant human tumor necrosis factor-αt receptor Ⅱ IgG Fc fusion protein (rhTNFR:Fc) and methotrexate (MTX) in patients with rheumatoid arthritis (RA). MethodsThirty patients with highly active RA were treated with rhTNFR:Fc (25 mg subcutaneously twice weekly) and oral MTX (up to 15 mg weekly). Clinical efficacy was assessed using ACR response criteria and the disease activity score in 28 joints (DAS28).Radiographs of the hands and wrists were assessed with the modified Sharp score. Chi-square test, Fisher is exact test and paired t-test were performed. ResultsAt week 52, ACR20, ACR50 and ACR70 responses were achieved by 90%, 87% and 67% respectively. At week 52, mean DAS28 was 3.4±1.1 compared to 6.4±0.6 at base-line(P<0.01), with 23% patients achieving clinical remission and 17% patients in low disease activity. Similarly, the HAQ was improved significantly, declining from 1.18±0.56 at base-line to 0.25t±0.34 at week 52 (P<0.01). No radiographic progression was found in 22 cases. Adverse events were mild in general.ConclusionTreatment with rhTNFR:Fc plus MTX has shown good efficacy throughout 52 study period in reducing disease activity, improving function, and retarding radiographic progression. Combination therapy for 52 weeks can achieve disease remission and no radiographic progression, which are the two goals of therapy for RA.
2.Orthostatic hypotension predicts cognitive impairment in the elderly: findings from a cohort study
Haixia HUANG ; Fang LIU ; Tianheng ZHENG ; Zhuoli WU ; Jiandao YANG ; Jingjing XIAO ; Shaoshi WANG
Chinese Journal of Neuromedicine 2016;15(12):1274-1278
Objective To explore the relationship between orthostatic hypotension (OH) and cognition impairment (CI) in the elderly.Methods Forty-four OH patients who visited our hospital due to dizziness,vertigo and fatigue during January 2009 to December 2011 were enrolled in the exposed group (OH group),and 88 healthy elderly paired in 1:2 were enrolled in the control group (NOH group).The socio-demographic data and cognition-related factors between the two groups were collected at baseline;cognitive function was assessed using mini-mental state examination (MMSE) 4 years after baseline of the present study.Results The overall incidence of CI was 14.0% among the 114 subjects who completed the follow-up assessment.Significant difference in CI incidence was noted between OH group (23.7%) and NOH group (9.2%,x2=4.399,P=0.036).The analysis by age showed that there was no significant difference in CI incidence between the OH group (15.4%) and NOH group (9.1%) among the elderly younger than 70 years;the CI incidence in OH group (41.7%) was significantly higher than that in NOH group (9.3%) among the elderly older than 70 years (x2=5.935,P=0.016).Conclusion OH is a risk factor of CI among the elderly older than 70 years.
3.Efficacy, safety, and cost-effectiveness of triple therapy in preventing relapse in rheumatoid arthritis: A randomized controlled trial (ESCoRT study).
Juan ZHAO ; Wei ZHOU ; Yangfeng WU ; Xiaoyan YAN ; Li YANG ; Zhuoli ZHANG
Chinese Medical Journal 2022;135(18):2200-2209
BACKGROUND:
Biological agents, such as tumor necrosis factor inhibitors (TNFi), have been widely used in rheumatoid arthritis (RA) patients and greatly improved goal achievement. The aim of this study was to investigate whether conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) combination was better in reducing relapse than methotrexate (MTX) monotherapy, and more cost-effective than continuing TNFi plus MTX in RA patients who achieved low disease activity (LDA) with TNFi and MTX therapy.
METHODS:
RA patients who failed to csDMARDs received an induction therapy of MTX plus TNFi for maximally 12 weeks. Those achieving LDA in 12 weeks were randomly assigned at a 1:1:1 ratio into three groups: (A) adding hydroxychloroquine and sulfasalazine for the first 12 weeks and then discontinuing TNFi for the following 48 weeks; (B) maintaining TNFi and MTX for 60 weeks; and (C) maintaining TNFi and MTX for the first 12 weeks and then discontinuing TNFi for the following 48 weeks. The primary outcome was relapse.
RESULTS:
A total of 117 patients were enrolled for induction therapy and 67 patients who achieved LDA within 12 weeks were randomized, with 24, 21, and 22 patients in groups A, B, and C, respectively. The relapse rates of groups A and B during the entire 60 weeks were comparable [10/22 (45.5%) vs. 7/20 (35.0%), χ2 = 0.475, P = 0.491], however, significantly lower than that of group C [10/22 (45.5%) vs. 17/20 (85.0%), χ2 = 5.517, P = 0.019; 7/20 (35.0%) vs. 17/20 (85.0%), χ2 = 11.035, P = 0.004, respectively]. Taking RMB 100,000 Yuan as the threshold of willingness to pay, compared to MTX monotherapy (group C), both TNFi maintenance and triple csDMARDs therapies were cost-effective, but triple csDMARDs therapy was better.
CONCLUSION:
For RA patients who have achieved LDA with TNFi and MTX, csDMARDs triple therapy was a cost-effective option in favor of reducing relapse.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02320630.
Humans
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Cost-Benefit Analysis
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Drug Therapy, Combination
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Treatment Outcome
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Arthritis, Rheumatoid/drug therapy*
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Antirheumatic Agents/therapeutic use*
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Methotrexate/therapeutic use*
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Recurrence
4.Recommendations for diagnosis and treatment of primary biliary cholangitis in China (2021)
Fengchun ZHANG ; Li WANG ; Zongwen SHUAI ; Zhenbiao WU ; Wen ZHANG ; Zhuoli ZHANG ; Jin LIN ; Yan ZHAO
Chinese Journal of Internal Medicine 2021;60(8):709-715
Primary biliary cholangitis is a chronic autoimmune cholestatic disease with a progressive course. This disease is not rare in China, but standardized diagnosis and treatment for primary biliary cholangitis are insufficient. Based on the evidence and guidelines from China and other countries, Rheumatology Branch of Chinese Medical Association developed the recommendations of diagnosis and treatment for primary biliary cholangitis in China. The aim is to help clinicians recognize clinical characters, therapeutic selection and prognosis judgement of primary biliary cholangitis, which will contribute to make diagnosis in time, to select treatment properly and to manage follow-up scientifically.