4.Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial.
Mengyan WANG ; Yu XUE ; Fang DU ; Lili MA ; Liang-Jing LU ; Lindi JIANG ; Yi-Li TAO ; Chengde YANG ; Hui SHI ; Honglei LIU ; Xiaobing CHENG ; Junna YE ; Yutong SU ; Dongbao ZHAO ; Sheng-Ming DAI ; Jialin TENG ; Qiongyi HU
Chinese Medical Journal 2023;136(3):331-340
BACKGROUND:
Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.
METHODS:
The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months.
RESULTS:
Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group.
CONCLUSION:
Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state.
TRIAL REGISTRATION
Chictr.org, ChiCTR2000039799.
Humans
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Quality of Life
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China
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Arthritis, Rheumatoid/drug therapy*
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Piperidines/therapeutic use*
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Treatment Outcome
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Antirheumatic Agents/therapeutic use*
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Pyrroles/therapeutic use*
5.Singapore Chapter of Rheumatologists Consensus Statement on the Eligibility for Government Subsidy of Biologic Disease Modifying Antirheumatic Agents for Treatment of Rheumatoid Arthritis (RA).
Gim Gee TENG ; Peter P CHEUNG ; Manjari LAHIRI ; Jane A CLAYTON ; Li Ching CHEW ; Ee Tzun KOH ; Wei Howe KOH ; Tang Ching LAU ; Swee Cheng NG ; Bernard Y THONG ; Archana R VASUDEVAN ; Jon K C YOONG ; Keng Hong LEONG
Annals of the Academy of Medicine, Singapore 2014;43(8):400-411
INTRODUCTIONUp to 30% of patients with rheumatoid arthritis (RA) respond inadequately to conventional non-biologic disease modifying antirheumatic drugs (nbDMARDs), and may benefit from therapy with biologic DMARDs (bDMARDs). However, the high cost of bDMARDs limits their widespread use. The Chapter of Rheumatologists, College of Physicians, Academy of Medicine, Singapore aims to define clinical eligibility for government-assisted funding of bDMARDs for local RA patients.
MATERIALS AND METHODSEvidence synthesis was performed by reviewing 7 published guidelines on use of biologics for RA. Using the modified RAND/UCLA Appropriateness Method (RAM), rheumatologists rated indications for therapies for different clinical scenarios. Points reflecting the output from the formal group consensus were used to formulate the practice recommendations.
RESULTSTen recommendations including diagnosis of RA, choice of disease activity measure, initiation and continuation of bDMARD and option of first and second-line therapies were formulated. The panellists agreed that a bDMARD is indicated if a patient has (1) active RA with a Disease Activity Score in 28 joints (DAS28) score of ≥3.2, (2) a minimum of 6 swollen and tender joints, and (3) has failed a minimum of 2 nbDMARD combinations of adequate dose regimen for at least 3 months each. To qualify for continued biologic therapy, a patient must have (1) documentation of DAS28 every 3 months and (2) at least a European League Against Rheumatism (EULAR) moderate response by 6 months after commencement of therapy.
CONCLUSIONThe recommendations developed by a formal group consensus method may be useful for clinical practice and guiding funding decisions by relevant authorities in making bDMARDs usage accessible and equitable to eligible patients in Singapore.
Antirheumatic Agents ; economics ; therapeutic use ; Arthritis, Rheumatoid ; drug therapy ; Financing, Government ; Humans ; Practice Guidelines as Topic ; Singapore
6.Expert recommendations for the chronic disease management of rheumatic arthritis.
Chinese Journal of Internal Medicine 2023;62(11):1256-1265
Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disease that poses a major healthcare challenge. In China, approximately 5 million patients are reported to have RA. Notably, Chinese patients with RA often experience a prolonged disease course and increased disease activity, leading to a substantial disease burden. The Chronic Disease Management Group of the Special Committee on Rheumatology and Immunology of Cross-Straits Medicine Exchange Association has advocated for an all-encompassing, continuous, and proactive scientific management approach for RA. This initiative has culminated in the formulation of the "Expert Recommendations for the Chronic Disease Management of Rheumatoid Arthritis", a comprehensive guideline developed through extensive consultations and consideration of the unique characteristics of RA. We have outlined 16 expert recommendations, addressing 10 key aspects central to RA management. We aim to enhance treatment outcomes for patients, streamline the distribution of medical resources, and reduce treatment-related burden on society, families, and individuals affected by this condition.
Humans
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Rheumatic Fever
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Arthritis, Rheumatoid/drug therapy*
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Rheumatology
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Chronic Disease
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Disease Management
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Antirheumatic Agents/therapeutic use*
7.Effectiveness of tofacitinib combined with iguratimod in the treatment of difficult-to-treat moderate-to-severe rheumatoid arthritis.
Xue ZOU ; Xiao Juan BAI ; Li Qing ZHANG
Journal of Peking University(Health Sciences) 2023;55(6):1013-1021
OBJECTIVE:
To investigate the efficacy and safety of iguratimod combined with tofacitinib in patients with difficult-to-treat moderate-to-severe rheumatoid arthritis (RA).
METHODS:
In this prospective clinical study, 30 patients with difficult-to-treat moderate-to-severe RA who attended the Department of Rheumatology and Immunology of Shanxi Province Fenyang Hospital from September 2021 to June 2022 were selected. Twenty-three patients enrollment had been treated with 2 or more conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) for more than 6 months. At least, methotrexate or leflunomide was included. Seven patients were treated with conventional synthetic DMARDs combined with tumor necrosis factor antagonists. Because all the patients had not reached the target of treatment, the combination treatment regimen of DMARDs was changed to iguratimod and tofacitinib. The observation period was 12 weeks. Clinical data were collected before and after treatment. At the end of 4 weeks, 8 weeks and 12 weeks, the clinical data were collected such as swollen joints count (SJC), tender joints count (TJC), time of morning stiffness, clinical disease activity index (CDAI), health status assessment questionnaire (HAQ), and 28-joint disease activity score (DAS28) were included. We collected laboratory indicators, recorded the patient's medication, and observed some changes to see if any adverse drug reactions occurred during the treatment.
RESULTS:
There were significant differences in erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), platelet (PLT), SJC, TJC, DAS28 based on ESR(DAS28-ESR), time of morning stiffness, HAQ, CDAI, and anti-cyclic citrullinated peptide antibody before and after treatment. The differences had statistical significance (P < 0.05). There was no statistical differences in globulin before and after treatment (P>0.05). During the treatment of iguratimod combined with tofacitinib, there was no serious adverse reactions such as leukopenia, significant elevation of liver enzymes, allergy or thromboemblolic events that occurred in all the patients.
CONCLUSION
Iguratimod combined with tofacitinib in the treatment of difficult-to-treat moderate-to-severe RA may have efficacy. The machanism was improving the patients' recent clinical symptoms by reducing inflammatory indexes. This combination treatment regimen with iguratimod and tofacitinib has a good safety profile.
Humans
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Prospective Studies
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Arthritis, Rheumatoid/drug therapy*
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Antirheumatic Agents/therapeutic use*
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Treatment Outcome
8.How does Chinese medicine target cytokine imbalance in rheumatoid arthritis?
Chinese journal of integrative medicine 2013;19(11):874-880
Rheumatoid arthritis (RA) manifests as an imbalance between pro- and anti-inflammatory cytokines. Cytokine imbalance is suggested to play critical roles in the development of RA. Currently, various treatments for RA, including biological agents such as antibodies against inflammation mediators, or Chinese herbal medicines, intervene the disease by restoring the balance of cytokines. Chinese medicine (CM) can not only suppress the expression of pro-inflammatory cytokines, but also induce the expression of cytokines with anti-inflammatory and immunomodulatory effects. Thus, Chinese medicine can effectively reduce inflammatory cell infiltration into synovial tissue, pannus formation, and degradation of the extracellular matrix surrounding cartilage cells, thereby reducing subchondral bone damage. This paper reviews the changes of cytokine profiling during development of RA and discuss the mechanisms by which Chinese medicine restores the cytokine balance.
Animals
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Antirheumatic Agents
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therapeutic use
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Arthritis, Rheumatoid
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drug therapy
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Cytokines
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metabolism
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Drugs, Chinese Herbal
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therapeutic use
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Humans
10.Clinical symptoms effect of Tripterygium Glycosides Tablets alone or combined with methotrexate in treatment of rheumatoid arthritis: a Meta-analysis.
Xiao-Yue WANG ; Tai-Xian LI ; Zhi-Peng XUE ; Cheng LYU ; Hui-Zhen LI ; Yuan-Fang FAN ; Yi-Qun LI ; Ya-Ge TIAN ; Jun YANG ; Wen-Jia CHEN ; Min-Qun GUO ; Jing-Xia WANG ; Hong-Yan WU ; Yan-Qiong ZHANG ; Na LIN
China Journal of Chinese Materia Medica 2019;44(16):3533-3541
To systematically review the improvement effects of Tripterygium Glycosides Tables( TGT) alone or in combination with methotrexate( MTX) on the clinical signs and symptoms of rheumatoid arthritis( RA),and provide a basis for the rational use of TGT in clinic,in the current study,six literature databases including CNKI,Wan Fang,VIP,PubMed,EMbase,and Cochrane Library,were systematically searched,according to the inclusion and exclusion criteria. Review Manager 5.3 software was used to input the literatures,and we assessed the risk bias on the level of outcome indicators for each included literature. A total of 18 literatures were included,and the classification results showed that: compared with MTX,TGT alone can reduce the number of joint swelling( MD =0. 18,95%CI[-1.06,1.42],P = 0.78) and joint tenderness( MD =-0.06,95% CI[-1.69,1.56],P = 0.94) in RA patients with the same effect as MTX. In terms of drug combination,TGT combined with MTX had an advantage over MTX alone in lessening the morning stiffness time( MD = 18. 24,95% CI[12. 64,23. 84],P < 0. 000 01) of RA,joint tenderness( MD = 2. 65,95% CI[1. 85,3. 44],P<0.000 01) and joint swelling( MD = 3.01,95% CI[2.09,3.39],P< 0.000 01). In conclusion,this Meta-analysis suggest that TGT alone was superior to MTX in improving joint swelling and tenderness in RA patients,TGT combined with MTX may improve the clinical manifestation of RA patients better than MTX alone.
Antirheumatic Agents
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therapeutic use
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Arthritis, Rheumatoid
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drug therapy
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Drug Therapy, Combination
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Drugs, Chinese Herbal
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therapeutic use
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Glycosides
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therapeutic use
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Humans
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Methotrexate
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therapeutic use
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Tablets
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Treatment Outcome
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Tripterygium
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chemistry