scholarly journals Efficacy and Safety of Mesenchymal Stem Cells in Treatment of Complex Perianal Fistulas: A Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Fang Cheng ◽  
Zhong Huang ◽  
Zhi Li
Keyword(s):  
Adverse Events ◽  
Fibrin Glue ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Perianal Fistula ◽  
Control Group ◽  
Efficacy And Safety ◽  
Pelvic Magnetic Resonance Imaging ◽  
Perianal Fistulas ◽  
Subgroup Analyses

Complex perianal fistula is a highly debilitating and difficult to treat condition. Local mesenchymal stem cell (MSC) therapy for perianal fistula has shown considerable promise but still remains controversial. Therefore, we performed the meta-analysis to evaluate the efficacy and safety of local MSC therapy for complex perianal fistula. PubMed and Embase databases were searched for published randomized clinical trials (RCTs) that reported local MSC therapy for complex perianal fistulas. The effectiveness and safety data analysis was conducted using RevMan5.3. Subgroup analyses were performed based on the characteristics of the studies. Seven RCTs with 730 participants were included. Local MSC treatment showed significantly higher healing rate (HR) of perianal fistulas compared to control (odds ratio (OR) = 2.03; 95% confidence interval (CI) 1.50, 2.74; P < 0.00001 ). MSCs combined with fibrin glue therapy can improve the HR compared with fibrin glue alone ( OR = 3.27 ; 95% CI 1.15, 9.28; P = 0.03 ). Subgroup analyses showed that local therapy can improve the HR in patients with perianal fistulas associated with Crohn’s disease (CD) ( OR = 2.05 ; 95% CI 1.41, 3.00; P = 0.0002 ) and cryptoglandular origin (no-Crohn) ( OR = 2.98 ; 95% CI 0.86, 10.29; P = 0.08 ). The pooled OR for studies that combined reepithelialization of the external opening with pelvic magnetic resonance imaging (MRI) to evaluate the healing of fistulas was 1.77 (95% CI 1.28, 2.45; P = 0.0006 ). The pooled OR for studies where fistula healing was defined as complete reepithelialization of external openings was 5.92 (95% CI 1.34, 26.15; P = 0.02 ). Both autologous MSCs ( OR = 3.19 ; 95% CI 1.05, 9.65; P = 0.04 ) and allogeneic MSCs ( OR = 1.97 ; 95% CI 1.34, 2.91; P = 0.0006 ) can obtain higher HR for perianal fistula compared with control. The adipose-derived MSC group can obtain higher HR than the control group ( OR = 2.29 ; 95% CI 1.38, 3.79; P = 0.001 ). There were no significant differences in adverse events (AEs) ( OR = 1.06 ; 95% CI 0.71, 1.59; P = 0.77 ). None of the adverse events was judged to be related to MSCs. Our study supported that local MSC therapy alone or combined with fibrin glue is safe and efficacious for complex perianal fistula. In the future, more RCTs are needed to confirm this conclusion.

Clinical Efficacy and Safety of Omalizumab in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis of Randomized Clinical Trials

2019 ◽  
Vol 34 (2) ◽  
pp. 196-208 ◽  
Author(s):  
Chenjie Yu ◽  
Kaijian Wang ◽  
Xinyan Cui ◽  
Ling Lu ◽  
Jianfei Dong ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Symptom Score ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Symptom Scores

Background Patients with moderate to severe allergic rhinitis (AR) who are treated according to the current rhinitis management guidelines may be inadequately controlled. These patients are at risk of serious comorbidities, such as asthma and chronic sinusitis. These symptoms, sneezing and an itchy, runny, stuffy nose, may have a negative impact on patients’ daily functioning. Omalizumab is being developed as a new choice for the treatment of AR. We therefore undertook a meta-analysis to assess the efficacy and safety of omalizumab in the treatment of AR. Methods We systematically searched PubMed, Cochrane Library, and MEDLINE databases for randomized controlled studies on the treatment of AR with omalizumab. Our evaluation outcomes were symptom scores, medication efficacy, combined symptom and medication scores, and adverse events. We descriptively summarized and quantitatively synthesized original data to evaluate the efficacy and safety of omalizumab in the treatment of AR by using Stata12.0 software for meta-analyses. Results The results of our meta-analysis showed that there were statistically significant differences between the omalizumab group and the control group in the following aspects: daily nasal symptom score (standardized mean difference [SMD] = –0.443, 95% confidence interval [CI]: –0.538 to –0.347, P < .001); daily ocular symptom score (SMD = –0.385, 95% CI: –0.5 to –0.269, P < .001); daily nasal medication symptom scores (SMD = –0.421, 95% CI: –0.591 to –0.251, P < .001); proportion of days of emergency drug use (risk ratio [RR] = 0.488, 95% CI: 0.307 to 0.788, P < .005); rhinoconjunctivitis-specific quality of life questionnaire (SMD = –0.286, 95% CI: –0.418 to –0.154, P < .001); and overall evaluation (RR = 1.435, 95% CI: 1.303–1.582, P < .001). There was no statistically significant difference in safety indicator: adverse events (RR = 1.026, 95% CI: 0.916–1.150, P = .655). Conclusion Omalizumab is effective and relatively safe in patients with AR; omalizumab used in conjunction with special immunotherapy has shown promising results, especially in reducing adverse events.

scholarly journals Verification of the Efficacy and Safety of Qi-Replenishing Chinese Medicine in Treating Prediabetes: A Meta-Analysis and Literature Review

2020 ◽  
Vol 2020 ◽  
pp. 1-15
Author(s):  
Shujie Xia ◽  
Bizhen Gao ◽  
Shujiao Chen ◽  
Xuejuan Lin ◽  
Ping Zhang ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Blood Glucose ◽  
Chinese Medicine ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
Meta Analysis ◽  
Postprandial Blood Glucose ◽  
Syndrome Differentiation ◽  
Efficacy And Safety ◽  
Subgroup Analyses

Background. Qi-replenishing Chinese medicines (QCMs) are used for treating prediabetes in the traditional Chinese medicine (TCM) clinical practice. The aims of this meta-analysis were to (i) verify the efficacy and safety of QCMs in treating prediabetes and (ii) investigate the clinical outcomes between the trials complying with and not complying with the principle of “syndrome differentiation.” Methods. We included only randomized controlled clinical trials (RCTs) whose Jadad scores were not less than 4. The overall clinical outcomes, including the incidence rate of diabetes, normalization of blood glucose, changes in fasting blood glucose (FBG), 2 h postprandial blood glucose, HbA1c, and occurrence of adverse events, were evaluated. Subgroup analyses were performed. Results. A total of 11 RCTs that enrolled 2210 patients with prediabetes were included. We observed that overall treatment with QCMs significantly ameliorated the clinical outcomes of prediabetes without increasing incidence of adverse events. The results of subgroup analyses revealed that prescribing QCMs complying with syndrome differentiation ameliorated all the clinical indices, whereas prescribing not complying with syndrome differentiation could not achieve significant amelioration in FBG and HbA1c levels. Furthermore, the subgroup with syndrome differentiation reported more adverse events. Conclusions. The overall results suggested that QCMs are effective and safe in treating prediabetes. Results of subgroup analyses indicated that the groups with syndrome differentiation presented better efficacy but had a higher occurrence of adverse events. This study indicated the important role of the principle of syndrome differentiation in TCM and that the adverse events of QCMs cannot be ignored in TCM clinical practice.

scholarly journals The Efficacy and Safety of Acellular Matrix Therapy for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Clinical Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-12 ◽  
Author(s):  
Wentao Huang ◽  
Yongsong Chen ◽  
Nasui Wang ◽  
Guoshu Yin ◽  
Chiju Wei ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Healing Rate ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Complete Healing ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Efficacy And Safety ◽  
Acellular Matrix

Background. Acellular matrix (AM) therapy has shown promise in the treatment of diabetic foot ulcers (DFUs) in several studies. The clinical effects of AM therapy were not well established. Therefore, we conducted a meta-analysis of randomized clinical trials (RCTs) to examine the efficacy and safety of AM therapy for patients with DFUs. Methods. A literature search of 5 databases was performed to identify RCTs comparing AM therapy to standard therapy (ST) in patients with DFUs. The primary outcome was the complete healing rate and the secondary outcomes mainly included time to complete healing and adverse events. Results. Nine RCTs involving 897 patients were included. Compared with ST group, patients allocated to AM group had a higher complete healing rate both at 12 weeks (risk ratio RR=1.73, 95% confidence interval (CI): 1.31 to 2.30) and 16 weeks (RR=1.56, 95% CI: 1.28 to 1.91), a shorter time to complete healing (mean difference MD=−2.41; 95% CI: -3.49 to -1.32), and fewer adverse events (RR=0.64, 95% CI: 0.44 to 0.93). Conclusion. The present study suggests that AM therapy as an adjuvant treatment could further promote the healing of full-thickness, noninfected, and nonischemia DFUs. AM therapy also has a safety profile. More large well-designed randomized clinical trials with long follow-up duration are needed to further explore the efficacy and safety of AM therapy for DFUs.

scholarly journals The efficacy and safety of bamlanivimab treatment against COVID-19: A meta-analysis

2021 ◽  
Author(s):  
Huairong Xiang ◽  
Bei He ◽  
Yun Li ◽  
Xuan Cheng ◽  
Qizhi Zhang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Web Of Science ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Efficacy And Safety ◽  
Positive Treatment ◽  
The Cochrane Library

Background: Bamlanivimab is routinely used in the treatment of coronavirus disease 2019 (COVID-19) in worldwide. We performed a meta-analysis to investigate the efficacy and safety of bamlanivimab treatment in patients with COVID-19. Methods: We searched articles from Web of Science, PubMed, Embase, the Cochrane Library and MedRxiv between 30 January 2020 and August 5, 2021. We selected randomized clinical trials (RCTs) and observational studies with a control group to assess the efficiency of bamlanivimab in treating patients with COVID-19. Results: Our meta-analysis retrieved 3 RCTs and 7 cohort studies including 14461 patients. Bmlanivimab may help outpatients to prevent hospitalization or emergency department visit (RR 0.41 95%CI 0.29 to 0.58), reduce ICU admission (RR 0.47 95%CI 0.23 to 0.92) and mortality (RR 0.32 95%CI 0.13 to 0.77) from the disease. The combination of bamlanivimab and etesevimab may had a greater potential for positive treatment outcome. Conclusion: Bamlanivimab has demonstrated clinical efficacy on mild or moderate ill patients with COVID-19 to prevent hospitalization, reduce severity and mortality from the disease. Combinations of two or more monoclonal antibody increase the effect. Well-designed clinical trials to identify the clinical and biochemical characteristics in COVID-19 patients'population that could benefit from bamlanivimab are warranted in the future.

scholarly journals A Meta-Analysis of the Efficacy of Panax Ginseng on Menopausal Women’s Sexual Function

2018 ◽  
Vol 7 (1) ◽  
pp. 124-133 ◽  
Author(s):  
Zahra Ghorbani ◽  
Mojgan Mirghafourvand
Keyword(s):  
Sexual Dysfunction ◽  
Adverse Events ◽  
Sexual Function ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Cochrane Library ◽  
Control Group ◽  
Placebo Control ◽  
Significant Difference

Objectives: An increase in life expectancy results in the aging population growth. This study was designed to evaluate the efficacy and adverse events of ginseng that could be used as a herbal medicine in women with sexual dysfunction. Materials and Methods: The authors of this study searched Cochrane Library, MEDLINE, Web of Science, Embase, Scopus, ProQuest, Google Scholar, and Persian databases without a time limitation until May 2018 and examined all the randomized clinical trials (RCTs) that compared the effect of different types of ginseng on sexual function of menopausal women as compared to the placebo controls. The Cochrane risk of bias tool was used to assess the methodological quality of the included studies. The heterogeneity was determined using the I2 index. In addition, standardized mean difference (SMD) was used instead of mean differences (MD) and a random effect was reported instead of fixed effect in meta-analysis. Results: The eligibility criteria were found in five RCTs. All the included studies were placebo-controlled. Two trials had a parallel design while three studies used a crossover design. Although four trials indicated that ginseng significantly improved sexual function, they didn’t report any treatment effect compared to the placebo group. Based on the results of meta-analysis obtained from five studies including 531 women, there was no statistically significant effect of ginseng on female sexual dysfunction (FSD) compared to the placebo control group (SMD: 0.26; 95% CI: -0.26 to 0.76). Nonetheless, there was a considerable heterogeneity among the studies (I2 = 81%; P < 0.0001). Moreover, all the included studies assessed adverse events, but in three of the RCTs, there was no significant difference between the placebo and ginseng groups. Conclusions: The evidence regarding ginseng as a therapeutic agent for sexual dysfunction is unjustifiable. Rigorous studies seem warranted in this respect.

scholarly journals Optimal treatment strategy of fremanezumab in migraine prevention: a systematic review with network meta-analysis of randomized clinical trials

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
I-Hsin Huang ◽  
Po-Chien Wu ◽  
Ya-Han Lee ◽  
Yi-No Kang
Keyword(s):  
Adverse Events ◽  
Treatment Strategy ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Reduction Rate ◽  
High Dose ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Mean Differences

Abstract Identifying the optimal fremanezumab treatment strategy is crucial in treating patients with migraines. The optimal strategy was investigated by assessing the cumulative 50% reduction rate (50%CRR), cumulative 75% reduction rate (75%CRR), reduction in the number of migraine days, treatment-related adverse events, and serious adverse events in patients treated with fremanezumab 225 mg monthly (225 mg), 675 mg monthly (675 mg), 900 mg monthly (900 mg), a single high dose of 675 mg (S675mg), 675 mg at baseline with 225 mg monthly (675/225 mg), and placebo. Biomedical databases were searched for randomized controlled trials on this topic, and data were individually extracted. Risk ratios and mean differences were used to present the pooled results. The surface under the cumulative ranking curve (SUCRA) was used to determine the effects of the medication strategies of fremanezumab. Five trials (n = 3404) were used to form a six-node network meta-analysis. All fremanezumab medication strategies displayed significantly higher cumulative 50% reduction rates than the placebo. The SUCRA revealed that treatment with 675 mg yielded the highest 50%CRR value (mean rank = 2.5). S675 mg was the only treatment with significantly higher 75%CRR reduction rate than placebo, whereas the SUCRA for 225 mg displayed the highest mean rank (2.2). Moreover, 225 mg (mean rank = 2.2) and S675 mg (mean rank = 2.2) presented lower probabilities of serious adverse events. Collectively, S675mg and 225 mg exhibited the optimal balance between efficacy and safety within three months. Long-term efficacy and safety remain unclear, and future studies should further evaluate the long-term outcomes.

scholarly journals Clinical Efficacy and Safety of Mesenchymal Stem Cells for Systemic Lupus Erythematosus

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Tianbiao Zhou ◽  
Hong-Yan Li ◽  
Chunling Liao ◽  
Wenshan Lin ◽  
Shujun Lin
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Adverse Events ◽  
Lupus Erythematosus ◽  
Meta Analysis ◽  
Case Series ◽  
Control Group ◽  
Efficacy And Safety ◽  
Systemic Lupus

Systemic lupus erythematosus (SLE) is a polymorphic, multisystemic autoimmune disease that causes multiorgan damage in which cellular communication occurs through the involvement of autoantibodies directed against autoantigen production. Mesenchymal stem cells (MSCs), which have strong protective and immunomodulatory abilities, are obtained not only from bone marrow but also from medical waste such as adipose tissue and umbilical cord tissue and have been recognized as a promising tool for the treatment of various autoimmune diseases and inflammatory disorders. This meta-analysis is aimed at assessing whether MSCs can become a new treatment for SLE with good efficacy and safety. Based on predetermined criteria, a bibliographical search was performed from January 1, 2000, to July 31, 2019, by searching the following databases: ISI Web of Science, Embase, PubMed, the Cochrane Library, and the Chinese Biomedical Literature Database (CBM). Eligible studies and data were identified. Statistical analysis was conducted to assess the efficacy (proteinuria, systemic lupus erythematosus disease activity index (SLEDAI), Scr, BUN, albumin, C3, and C4) and safety (rate of adverse events) of MSCs for SLE using Cochrane Review Manager Version 5.3. Ten studies fulfilled the inclusion criteria and were eligible for this meta-analysis, which comprised 8 prospective or retrospective case series and four randomized controlled trails (RCTs) studies. In the RCT, the results indicated that the MSC group had lower proteinuria than the control group at 3 months and 6 months and the MSC group displayed a lower SLEDAI than the control group at 2 months and 6 months. Furthermore, the MSC group showed a lower rate of adverse events than the control group (OR=0.26, 95% CI: 0.07, 0.89, P=0.03). In the case series trials, the results indicated that the MSC group had lower proteinuria at 1 month, 2 months, 3 months, 4 months, 6 months, and 12 months. In conclusion, MSCs might be a promising therapeutic agent for patients with SLE.

scholarly journals A Systematic Review about the Efficacy and Safety ofTripterygium wilfordiiHook.f. Preparations Used for the Management of Rheumatoid Arthritis

2018 ◽  
Vol 2018 ◽  
pp. 1-13 ◽  
Author(s):  
Jing Wang ◽  
Na Chen ◽  
Liang Fang ◽  
Zhe Feng ◽  
Guochun Li ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Adverse Events ◽  
Meta Analysis ◽  
Chinese Herb ◽  
Current Evidence ◽  
Control Group ◽  
Efficacy And Safety ◽  
Tripterygium Wilfordii ◽  
Reactive Protein

Tripterygium wilfordiiHook.f. (TWHF) is a traditional Chinese herb long used for rheumatoid arthritis (RA) treatment, in modern times, often in the form of variousTripterygium wilfordiiHook.f. preparations (TWPs). This systematic review and meta-analysis focuses on analyzing the clinical efficacy and safety of TWPs in the treatment of RA. Databases were searched to collect the randomized controlled trials (RCTs) on TWPs treating RA published on or before April 10, 2017. Data from 11 studies were included in this meta-analysis. Compared with the control group, TWPs can increase effectiveness, while decreasing erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), C-reactive protein (CRP), and risk of adverse events. TWPs treatment was also more effective than treatment by conventional western medicine (CWM) and Chinese patent medicine or placebo (COP). TWPs significantly decreased the risk of adverse events compared with the CWM group, but not compared with the COP group. Current evidence shows that TWPs are more effective than other western or Chinese medicines we included in this meta-analysis for RA treatment with relatively lower toxicity.

scholarly journals Efficacy and safety of hydroxychloroquine as pre-and post-exposure prophylaxis and treatment of COVID-19. Systematic review and meta-analysis of blinded, placebo-controlled, randomized clinical trials

2021 ◽  
Author(s):  
Paulo Ricardo Martins-Filho ◽  
Lis Campos Ferreira ◽  
Luana Heimfarth ◽  
Adriano Antunes de Souza Araujo ◽  
Lucindo Jose Quintans-Junior
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Hospitalized Patients ◽  
Post Exposure Prophylaxis ◽  
Potential Candidate ◽  
Efficacy And Safety ◽  
Post Exposure ◽  
Exposure Prophylaxis

BACKGROUND Hydroxychloroquine (HCQ) is an anti-malarial and immunomodulatory drug considered a potential candidate for drug repurposing in COVID-19 due to their in vitro antiviral activity against SARS-CoV-2. Despite the potential antiviral effects and anti-inflammatory profile, the results based on clinical studies are contradictory and the quality of the decision-making process from meta-analyses summarizing the available evidence selecting studies with different designs and unblinded trials is limited. The aim of this study was to synthesize the best evidence on the efficacy and safety of HCQ as pre-and post-exposure prophylaxis and treatment of non-hospitalized and hospitalized patients with COVID-19. METHODS Searches for studies were performed in PubMed, Web of Science, Embase, Lilacs, the website ClinicalTrials.gov and the preprint server medRxiv from January 1, 2020 to May 17, 2021. The following elements were used to define eligibility criteria: (1) Population, individuals at high-risk of exposure to SARS-CoV-2 (pre-exposure), individuals who had close contact with a positive or probable case of COVID-19 (post-exposure), non-hospitalized patients with COVID-19 and hospitalized patients with COVID-19; (2) Intervention, HCQ; (3) Comparison, placebo; (4) Outcomes: incidence of SARS-CoV-2 infection, need for hospitalization, length of hospital stay, need for invasive mechanical ventilation (MV), death, and adverse events; and (5) Study type, blinded, placebo-controlled, randomized clinical trials (RCTs). Risk of bias was judged according to the Cochrane guidelines for RCTs. Treatment effects were reported as relative risk (RR) for dichotomous variables and mean difference (MD) for continuous variables with 95% confidence intervals (CI). We used either a fixed or random-effects model to pool the results of individual studies depending on the presence of heterogeneity. The GRADE system was used to evaluate the strength of evidence between use of HCQ and the outcomes of interest. RESULTS Fourteen blinded, placebo-controlled RCTs were included in the meta-analysis. Four trials used HCQ as a prophylactic medication pre-exposure to COVID-19, two as a prophylactic medication post-exposure to COVID-19, three as treatment for non-hospitalized patients, and five as treatment for hospitalized patients with COVID-19. We found no decreased risk of SARS-CoV-2 infection among individuals receiving HCQ as pre-exposure (RR = 0.90; 95% CI 0.46 to 1.77) or post-exposure (RR = 0.96; 95% CI 0.72 to 1.29) prophylaxis to prevent COVID-19. There is no decreased risk of hospitalization for outpatients with SARS-CoV-2 infection (RR = 0.64; 95% CI 0.33 to 1.23) and no decreased risk of MV (RR = 0.81; 95% CI 0.49 to 1.34) and death (RR = 1.05; 95% CI 0.62 to 1.78) among hospitalized patients with COVID-19 receiving HCQ. The certainty of the results on the lack of clinical benefit for HCQ was rated as moderate. Moreover, our results demonstrated an increased risk for any adverse events and gastrointestinal symptoms among those using HCQ. CONCLUSION Available evidence based on the results of blinded, placebo-controlled RCTs showed no clinical benefits of HCQ as pre-and post-exposure prophylaxis and treatment of non-hospitalized and hospitalized patients with COVID-19.

scholarly journals Safety of IL-23/17 Antagonists in Patients with Psoriasis or Other Immune-mediated Inflammatory Diseases: A Systematic Meta-Analysis.

2020 ◽  
Author(s):  
Siying Li ◽  
Suhan Zhang ◽  
Guishao Tang ◽  
Ruifang Wu ◽  
Yuwen Su
Keyword(s):  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Inflammatory Diseases ◽  
Meta Analysis ◽  
Cardiovascular Disorder ◽  
Control Group ◽  
Placebo Control ◽  
Serious Adverse Events ◽  
Immune Mediated ◽  
Increased Risk

Abstract Background: The IL-23/17 axis plays central role in the pathogenesis of several immune-mediated inflammatory diseases (IMIDs). IL-23/17 antagonists showed significant improvement in the treatment for psoriasis and other IMIDs, including psoriasis(PSO), psoriatic arthritis(PsA), rheumatoid arthritis(RA) and ankylosing spondylitis(AS).Objective: To assess the safety of IL-23/17 antagonists therapy on patients with psoriasis and other IMIDs.Methods: Pooled analysis from thirty-nine placebo-controlled randomized clinical trials (RCTs) of IL-23/17 axis antagonists for IMIDs. Incidences of adverse events (AEs), serious adverse events (SAEs) and AEs of interest were applied to evaluate the safety profile.Result: A Total of 15967 patients were exposed to IL-23/17 axis antagonists. The proportions of patients suffered at least one AE in antagonists group and placebo-control group are 67.5% and 51.1% respectively. Incidence of SAE was increased in patients treated with IL-23/17 axis antagonists compared to patients given placebo (relative risk 2.03; 95% CI, 1.62, 2.56). Incidence of AEs of interest were all increased in patients treated with IL-23/17 axis antagonists compared to patients given placebo.Conclusion: In this analysis, we found increased risk of AEs, SAEs, nervous system disorder, cardiovascular disorder and hypertension among patients with IMIDs treated with IL-23/17 axis antagonists.

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