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Efficacy and safety of tacrolimus in patients with rheumatoid arthritis - A systematic review and meta-analysis.
Kaneko, Y, Kawahito, Y, Kojima, M, Nakayama, T, Hirata, S, Kishimoto, M, Endo, H, Seto, Y, Ito, H, Nishida, K, et al
Modern rheumatology. 2021;(1):61-69
Abstract
OBJECTIVES To evaluate the efficacy and safety of tacrolimus in adult patients with rheumatoid arthritis (RA) by using the GRADE approach. METHODS We searched PubMed, Japana Centra Revuo Medicina Web (Ichu-shi web), and the Cochrane Database of Systematic Reviews. Articles fulfilling the predefined inclusion criteria were appraised and used for meta-analysis. The primary outcomes were American College of Rheumatology 20 (ACR20) and serum creatinine elevation. Other outcomes included ACR50, ACR70, changes in C-reactive protein, modified Health Assessment Questionnaire Disability Index, gastrointestinal disorders, metabolic and nutritional disorders, and infections and infestations. RESULTS We identified five randomized controlled studies, four of which compared tacrolimus to placebo and were included in the meta-analysis. The risk ratio of ACR20 achievement was 1.71 (95% confidence interval [CI] 1.20-2.42) for 1-2 mg/day and 2.30 (95% CI 1.79-2.96) for 3 mg/day. The risk ratio of creatinine elevation was 1.95 (95% CI 1.18-3.23) for 1-2 mg/day and 3.81 (95% CI 2.43-5.99) for 3 mg/day. CONCLUSION Tacrolimus is effective with acceptable safety in the management of RA.
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Clinical safety of total glucosides of paeony adjuvant therapy for rheumatoid arthritis treatment: a systematic review and meta-analysis.
Liu, B, Meng, X, Ma, Y, Li, H, Liu, Y, Shi, N, Chen, Y, Wang, Y, Lu, C
BMC complementary medicine and therapies. 2021;(1):102
Abstract
BACKGROUND Total glucosides of paeony (TGP), an active compound extracted from the roots of Paeonia lactiflora Pallas, has been increasingly used as the adjunctive therapy for rheumatoid arthritis (RA) patients. Though TGP could mitigate the unanticipated adverse effects during the conventional treatment of RA, high-quality evidence-based meta-analysis data on this subject are still insufficient. The objective of this study is to evaluate the clinical safety of TGP adjuvant therapy in the RA treatment. METHODS PubMed, EMBASE, Web of Science, China Network Knowledge Infrastructure (CNKI), SinoMed and WanFang Data were retrieved for randomized controlled trials (RCTs) and cohort study about TGP adjuvant therapy in patients with RA up to 28 January 2021. Literatures with eligibility criteria and information were screened and extracted by two researchers independently. The RevMan5.3 software was used for data analysis with effect estimates as risk ratio (RR) with 95% confidence interval (CI). RESULTS A total of 39 studies involving 3680 RA participants were included. There were 8 comparisons: TGP plus methotrexate (MTX) therapy versus MTX therapy, TGP plus leflunomide (LEF) therapy versus LEF therapy, TGP plus MTX and LEF therapy versus MTX plus LEF therapy, TGP plus tripterygium glycosides (TG) therapy versus TG therapy, TGP plus meloxicam (MLX) therapy versus MLX therapy and TGP plus sulfasalazine (SSZ) therapy versus SSZ therapy, TGP plus iguratimod (IGU) therapy versus IGU therapy, TGP plus prednisone acetate tablets (PAT) therapy versus PAT therapy. The meta-analysis results showed that the occurrence of hepatic adverse effect (RR = 0.31, 95% CI = 0.23-0.41, P < 0.00001) and leukopenia (RR = 0.41, 95% CI = 0.26-0.66, P = 0.0002) in TGP adjuvant therapy was significant decreased compared with non-TGP therapy. However, only TGP plus LEF therapy (RR = 0.22, 95% CI = 0.08-0.60, P = 0.003) and TGP plus MTX and LEF therapy (RR = 0.31, 95% CI = 0.22-0.42, P < 0.00001) had statistical difference in the subgroups of hepatic adverse effect. In leukopenia, TGP plus MTX and LEF therapy (RR = 0.47, 95% CI = 0.25-0.87, P = 0.02) had statistical difference. CONCLUSIONS This meta-analysis indicated that TGP adjuvant therapy might alleviate the incidence of hepatic adverse effect and leukopenia for the RA treatment compared to non-TGP therapy. The clinical safety of TGP adjuvant therapy warrant further investigation in experimental studies.
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Cytopenias among patients with rheumatic diseases using methotrexate: a meta-analysis of randomized controlled clinical trials.
Vanni, KMM, Lyu, H, Solomon, DH
Rheumatology (Oxford, England). 2020;(4):709-717
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Abstract
OBJECTIVE To conduct a systematic literature review and meta-analysis to estimate the incidence of anaemia, leucopoenia, neutropenia and thrombocytopenia associated with MTX plus folic acid among patients with rheumatic diseases. METHODS We searched MEDLINE, PubMed and EMBASE through August 2016 for all randomized controlled clinical trials with a MTX monotherapy arm. We excluded randomized controlled clinical trials for cancer and included only double-blind studies that reported on haematologic adverse events. Studies were excluded if patients did not receive folic acid or leucovorin supplementation. Full text articles were assessed by two independent reviewers. Incidence estimates were calculated using random-effects models. RESULTS Of 1601 studies identified, 30 (1.87%) were included, representing 3858 patients; all had RA. Seventeen trials reported on anaemia (n = 2032), 17 reported on leucopoenia (n = 2220), 16 reported on neutropenia (n = 2202) and 12 reported on thrombocytopenia (n = 1507). The incidence for any anaemia was 2.55% (95% CI 0.60-5.47%), any leucopoenia 1.17% (95% CI 0.16-2.80%), any neutropenia 1.77% (95% CI 0.33-4.00%), and any thrombocytopenia 0.19% (95% CI 0.00-0.86%). Four cases of severe anaemia were reported, as defined by authors, along with three cases of severe neutropenia. No cases of severe leucopoenia, severe thrombocytopenia or pancytopenia were reported. CONCLUSION Cytopenias are an uncommon side effect of low-dose MTX with folic acid supplementation among RA patients. Further research is needed to reach a more precise estimate.
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Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy for active rheumatoid arthritis.
Ho Lee, Y, Gyu Song, G
Journal of clinical pharmacy and therapeutics. 2020;(4):674-681
Abstract
WHAT IS KNOWN AND OBJECTIVE Several clinical trials have attempted to evaluate the efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy in patients with active rheumatoid arthritis (RA), but their relative efficacy and safety as monotherapy remain unclear due to the lack of data from head-to-head comparison trials. The relative efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy for rheumatoid arthritis (RA) were assessed. METHODS We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) and examine the efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy relative to placebo in patients with RA. RESULTS AND DISCUSSION Five RCTs comprising 1547 patients met the inclusion criteria. Compared with placebo, tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy showed a significantly higher American College of Rheumatology 20% (ACR20) response rate. Peficitinib 150 mg monotherapy showed the highest ACR20 response rate (odds ratio, 17.24.39; 95% credible interval, 6.57-51.80). The ranking probability based on the surface under the cumulative ranking curve indicated that peficitinib 150 mg had the highest probability of being the best treatment for achieving the ACR20 response rate, followed by peficitinib 100 mg, filgotinib 200 mg, filgotinib 100 mg, tofacitinib 5 mg, upadacitinib 15 mg, baricitinib 4 mg and placebo. However, the number of patients who experienced serious adverse events did not differ significantly between the JAK inhibitors, except for tofacitinib 5 mg, and placebo. WHAT IS NEW AND CONCLUSION All five JAK inhibitors-tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib-were efficacious monotherapy interventions for active RA, and differences were noted in their efficacy and safety in monotherapy.
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Associations of four common VDR polymorphisms with rheumatoid arthritis and systemic lupus erythematosus: evidence from a meta-analysis.
Zhang, WT, Jin, TF, Chen, L
Lupus. 2020;(4):364-370
Abstract
Associations of polymorphisms in vitamin D receptor (VDR) with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) have already been explored by many studies. The aim of this meta-analysis was to better clarify associations between polymorphisms in VDR and RA/SLE by combing the results of all relevant studies. Eligible studies were searched from Pubmed, Embase, WOS and CNKI. We used Review Manager to combine the results of eligible studies. Thirty-seven studies were included in this meta-analysis. VDR rs1544410 (recessive comparison: odds ratio (OR) = 1.36, 95% confidence interval (CI) 1.06-1.76; over-dominant comparison: OR = 0.81, 95% CI 0.71-0.93) and rs731236 (over-dominant comparison: OR = 0.77, 95% CI 0.63-0.94) polymorphisms were found to be significantly associated with RA in overall combined analyses. Besides, VDR rs1544410 (dominant comparison: OR = 0.61, 95% CI 0.46-0.82; over-dominant comparison: OR = 1.45, 95% CI 1.16-1.81; allele comparison: OR = 0.75, 95% CI 0.62-0.92), rs2228570 (dominant comparison: OR = 0.58, 95% CI 0.50-0.67; recessive comparison: OR = 1.57, 95% CI 1.21-2.03; allele comparison: OR = 0.69, 95% CI 0.60-0.80) and rs731236 (dominant comparison: OR = 0.69, 95% CI 0.50-0.96; allele comparison: OR = 0.80, 95% CI 0.70-0.90) polymorphisms were also found to be significantly associated with SLE in overall combined analyses. Subgroup analyses revealed that significant associations for VDR polymorphisms and RA/SLE were mainly driven by Asians. Collectively, this meta-analysis proved that VDR rs7975232, rs1544410, rs2228570 and rs731236 polymorphisms may confer susceptibility to RA and SLE, especially for Asians.
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Comparative Efficacy and Safety of Peficitinib 25, 50, 100, and 150 mg in Patients with Active Rheumatoid Arthritis: A Bayesian Network Meta-Analysis of Randomized Controlled Trials.
Lee, YH, Song, GG
Clinical drug investigation. 2020;(1):65-72
Abstract
BACKGROUND AND OBJECTIVE Peficitinib, a JAK3-selective inhibitor that blocks the signal transduction and then suppresses immune responses, has been developed for the treatment of patients with moderate to severe active rheumatoid arthritis (RA). We assessed the relative efficacy and safety of once-daily administration of peficitinib (a JAK3-selective inhibitor) 25 mg, 50 mg, 100 mg, and 150 mg in patients with active RA. METHODS A Bayesian network meta-analysis was conducted to combine direct and indirect evidence from eligible randomized controlled trials (RCTs). The literature search was performed up to May 2019 using MEDLINE, Embase, and the Cochrane Controlled Trials Register. RESULTS Three RCTs involving 948 patients met the inclusion criteria. There were ten pairwise comparisons, including five direct comparisons and five interventions. The American College of Rheumatology 20% (ACR20) response rate was significantly higher in the peficitinib 150-mg group than in the placebo group (odds ratio (OR): 3.61; 95% credible interval (CrI): 2.35-5.57). Similarly, the ACR20 response rate was significantly higher in the peficitinib 100-mg group than in the placebo group (OR: 2.33, 95% CrI: 1.51-3.56). The peficitinib 50-mg group had a significantly higher ACR20 response rate than the placebo group. However, the ACR20 response rate was not significantly higher in the peficitinib 25-mg group than in the placebo group. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that peficitinib 150 mg was likely to achieve the best ACR20 response rate (SUCRA = 0.995), followed by peficitinib 100 mg (SUCRA = 0.696), peficitinib 50 mg (SUCRA = 0.558), peficitinib 25 mg (SUCRA = 0.153), and placebo (SUCRA = 0.098). The ACR50 and ACR70 response rates showed a similar distribution pattern to the ACR20 response rate. The difference in the number of patients with adverse events (AEs) among the intervention groups was not statistically significant. CONCLUSIONS Peficitinib 50, 100, and 150 mg once daily was effective in treating active RA, without causing a significant risk for AEs.
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Efficacy of Spice Supplementation in Rheumatoid Arthritis: A Systematic Literature Review.
Letarouilly, JG, Sanchez, P, Nguyen, Y, Sigaux, J, Czernichow, S, Flipo, RM, Sellam, J, Daïen, C
Nutrients. 2020;(12)
Abstract
BACKGROUND Spices, i.e., curcumin, ginger, saffron, and cinnamon, have a thousand-year history of medicinal use in Asia. Modern medicine has begun to explore their therapeutic properties during the last few decades. We aimed to perform a systematic literature review (SLR) of randomized controlled trials (RCTs) assessing the effect of spice supplementation on symptoms and disease activity in patients with chronic inflammatory rheumatic diseases (rheumatoid arthritis (RA), spondylarthritis, or psoriatic arthritis). METHODS An SLR of RCTs, reviews, and meta-analyses was performed, searching for articles in MEDLINE/PubMed. Abstracts from international rheumatology and nutrition congresses (2017-2020) were also scrutinized. The risk of bias of the selected studies was evaluated using the Cochrane Collaboration's tool and the Jadad scale. RESULTS Altogether, six studies, assessing the use of spice supplementation only in RA patients, were included: one on garlic supplementation, two on curcumin, one on ginger, one on cinnamon, and one on saffron supplementation. Garlic, ginger, cinnamon, or saffron supplementation was associated with a decrease in RA clinical activity. However, several points limit the external validity of these studies. No conclusion on the impact of curcumin supplementation on RA activity could be drawn due to low-quality studies. CONCLUSIONS Garlic, ginger, cinnamon, and saffron supplementation could have a beneficial effect on RA activity, but the risk of bias of these studies is difficult to assess and data are too limited to recommend them in daily practice.
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Rheumatoid arthritis patients have higher prevalence and burden of asymptomatic coronary artery disease assessed by coronary computed tomography: A systematic literature review and meta-analysis.
Hansen, PR, Feineis, M, Abdulla, J
European journal of internal medicine. 2019;:72-79
Abstract
BACKGROUND Rheumatoid arthritis (RA) is associated with increased risk of coronary artery disease (CAD) and studies with coronary computed tomography have suggested increased rates of asymptomatic CAD determined by the coronary calcium score (CCS) in these patients. To synthesize the evidence on this topic, we conducted a systematic review and meta-analysis of the literature. METHODS A systematic review was performed of data comparing the prevalence and burden of asymptomatic CAD in RA and controls using CCS with or without coronary computed tomographic angiography (CCTA). For the meta-analysis, pooled data provided the estimated risk ratio (RR) of CAD and weighted mean differences of CCS in patients with RA compared to controls. RESULTS The search revealed 1841 results of which 1083 were screened and 26 full text papers were evaluated. Eight studies were included with data on 788 patients with RA and 1641 controls. Patients with RA had significantly increased risk of CAD (RR = 1.26 [95% CI 1.04-1.52]; p = .021) and increased weighted mean differences for CCS (48.25 [95% CI 26.97-69.53]; p < .001) compared to controls. Limited evidence suggested that patients with RA had a higher prevalence of moderate-severe (CCS > 100) CAD and more multivessel CAD, and RA duration and disease activity were associated with higher CCS, RA disease activity was linked with presence of high risk (non-calcified or mixed) coronary plaques, and treatment with methotrexate was tied to absence of CAD, respectively. CONCLUSIONS In patients with RA, asymptomatic CAD is more prevalent, with higher mean CCS, more multivessel disease, and more high-risk plaques compared to controls.
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Common trace metals in rheumatoid arthritis: A systematic review and meta-analysis.
Ma, Y, Zhang, X, Fan, D, Xia, Q, Wang, M, Pan, F
Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS). 2019;:81-89
Abstract
INTRODUCTION Environmental risk factors regrading rheumatoid arthritis (RA) have not been explored extensively. Selenium (Se), zinc (Zn) and copper (Cu) nutrients were reported to associate with RA, but the results were inconsistent. Therefore, we conduct present study to meta-analyze the relationship between serum Se, Zn and Cu and RA and review the potential mechanisms. METHODS PubMed, Web of Science and Cochrane Library were comprehensively searched till October 1, 2018 for pertinent studies. Standard mean differences (SMDs) and 95% confident intervals (CIs) were calculated according to random effects model. RESULTS Finally 41 literatures were included. Meta-analysis of 16 studies involving 806 RA patients and 959 health controls showed that serum Se (SMD = -1.04, 95% CI = -1.58 to -0.50) was decreased in RA patients, and 23 literatures with 1398 patients and 1299 controls reported serum Zn (SMD = -1.20, 95% CI = -1.74 to -0.67) was decreased. But serum Cu (SMD = 1.26, 95% CI = 0.63 to -1.89) was increased with 26 studies including 1723 patients and 1451 controls. Meta-regression reported that steroid use was positively related to serum level of Se in RA (β = 0.041, 95% CI = 0.002 to 0.079). Differences in serum Se, Zn and Cu between rheumatoid arthritis patients and controls were all related with the geographical distribution. CONCLUSIONS Patients with RA have significant decreased serum Se and Zn and increased serum Cu than health controls, suggesting potential roles of Se, Zn and Cu in the pathogenesis of RA. Patients and rheumatologist should give enough attention to the monitor of these elements during follow up.
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Efficacy and safety of total glucosides of paeony combined with methotrexate and leflunomide for active rheumatoid arthritis: a meta-analysis.
Huang, Y, Wang, H, Chen, Z, Wang, Y, Qin, K, Huang, Y, Ba, X, Lin, W, Tu, S
Drug design, development and therapy. 2019;:1969-1984
Abstract
Purpose: Total glucosides of paeony (TGP) have been confirmed to reduce hepatotoxicity caused by methotrexate (MTX) and leflunomide (LEF) in rheumatoid arthritis (RA). Nevertheless, high-quality evidence-based meta-analysis data on the issue are unavailable. This study aimed to evaluate the efficacy and safety of this combination treatment for RA. Materials and methods: PubMed, EMBASE, Web of Science, Cochrane Library, ClinicalTrials, Chinese Biomedical Literature database, China National Knowledge Internet, Wan Fang, and VIP were searched up to February 2019. Randomized controlled trials (RCTs) on the efficacy and safety of TGP combined MTX and LEF for RA were included. Results: Eight RCTs were included in the final meta-analysis. Pooled results showed better therapeutic effects against RA in the TGP-treated group (RR =1.10, 95% CI: 1.04 -1.16). The TGP+MTX+LEF group showed a reduced erythrocyte sedimentation rate (MD = -2.80 mm/h, 95% CI: -5.08 - -0.52), C-reactive protein level (MD = -4.17 mg/L, 95% CI: -7.84 - -0.51), and rheumatoid factor (MD = -12.09 IU/mL, 95% CI: -14.05 - -10.14). Besides, the combination treatment tended to benefit lipid profiles (total cholesterol: 95% CI: -1.27-0.06; triglycerides: 95% CI: -0.49 - -0.08; high-density lipoprotein cholesterol: 95% CI: 0.15-0.83; and low-density lipoprotein cholesterol: 95% CI: -0.54 - -0.02). Adverse events, hepatotoxicity in particular, significantly decreased (RR =0.55, 95% CI: 0.38-0.80) in the TGP group. Conclusion: Compared to MTX and LEF therapy, TGP combination treatment may be a more effective and safer strategy. It is advisable to apply TGP as an adjuvant given its hepatoprotective and possible lipid-regulating effect. However, further large-scale and high-quality clinical trials are warranted, and the efficacy of TGP in terms of its effect on lipid profiles should be further confirmed.