scholarly journals A Systematic Literature Review of Adverse Events Associated with Systemic Treatments Used in Advanced Soft Tissue Sarcoma

Sarcoma ◽  
2016 ◽  
Vol 2016 ◽  
pp. 1-13 ◽  
Author(s):  
Ann Colosia ◽  
Shahnaz Khan ◽  
Michelle D. Hackshaw ◽  
Alan Oglesby ◽  
James A. Kaye ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Literature Review ◽  
Adverse Events ◽  
Systematic Literature Review ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Cochrane Central Register ◽  
Systemic Treatments ◽  
Cancer Agent

This systematic literature review describes adverse events (AEs) among patients with soft tissue sarcoma (STS) who received second-line or later anticancer therapies. Searches were conducted in PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for studies of adults with advanced or metastatic STS who received systemic anticancer therapy before enrollment in a randomized-controlled trial of pazopanib, another targeted cancer agent, or cytotoxic chemotherapy. Of 204 publications identified, seven articles representing six unique studies met inclusion criteria. Additional safety results for pazopanib were identified on ClinicalTrials.gov. Hematologic toxicities were common with all therapies evaluated (pazopanib, trabectedin, dacarbazine ± gemcitabine, gemcitabine ± docetaxel, cyclophosphamide, and ifosfamide). Studies differed in AE type, timing of assessment, and outcomes reported, although patient populations and AE assessment timing were relatively similar for pazopanib and trabectedin. AEs that were more common with trabectedin than pazopanib were anemia, neutropenia, nausea/vomiting, and elevations in aspartate aminotransferase and alanine aminotransferase. An AE that was more common with pazopanib than trabectedin was anorexia. Only the pazopanib study reported AE frequencies versus placebo. A planned meta-analysis was not feasible, as there was no common comparator. More well-designed studies that include common comparators are needed for comparison of safety effects among treatments for STS.

scholarly journals Tofacitinib versus Biologic Treatments in Moderate-to-Severe Rheumatoid Arthritis Patients Who Have Had an Inadequate Response to Nonbiologic DMARDs: Systematic Literature Review and Network Meta-Analysis

2017 ◽  
Vol 2017 ◽  
pp. 1-15 ◽  
Author(s):  
Evelien Bergrath ◽  
Robert A. Gerber ◽  
David Gruben ◽  
Tatjana Lukic ◽  
Charles Makin ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Adverse Events ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
Janus Kinase ◽  
Comparable Efficacy ◽  
Cochrane Central Register ◽  
Inadequate Response ◽  
Severe Rheumatoid Arthritis

Objective. To compare the efficacy and tolerability of tofacitinib, an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), as monotherapy and combined with disease-modifying antirheumatic drugs (DMARDs) versus biological DMARDs (bDMARDs) and other novel DMARDs for second-line moderate-to-severe rheumatoid arthritis (RA) patients by means of a systematic literature review (SLR) and network meta-analysis (NMA). Methods. MEDLINE®, EMBASE®, and Cochrane Central Register of Controlled Trials were searched to identify randomized clinical trials (RCTs) published between 1990 and March 2015. Efficacy data based on American College of Rheumatology (ACR) response criteria, improvements in the Health Assessment Questionnaire Disability Index (HAQ-DI) at 6 months, and discontinuation rates due to adverse events were analyzed by means of Bayesian NMAs. Results. 45 RCTs were identified, the majority of which demonstrated a low risk of bias. Tofacitinib 5 mg twice daily (BID) and 10 mg BID monotherapy exhibited comparable efficacy and discontinuation rates due to adverse events versus other monotherapies. Tofacitinib 5 mg BID and 10 mg BID + DMARDs or methotrexate (MTX) were mostly comparable to other combination therapies in terms of efficacy and discontinuation due to adverse events. Conclusion. In most cases, tofacitinib had similar efficacy and discontinuation rates due to adverse events compared to biologic DMARDs.

AB0820 COMPARATIVE EFFICACY OF GUSELKUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM SYSTEMATIC LITERATURE REVIEW AND NETWORK META-ANALYSIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1713-1714
Author(s):  
I. Mcinnes ◽  
P. J. Mease ◽  
K. Eaton ◽  
A. Schubert ◽  
S. Peterson ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Literature Review ◽  
Adverse Events ◽  
Systematic Literature Review ◽  
Targeted Therapies ◽  
Meta Analysis ◽  
Tumor Necrosis Factor Inhibitor ◽  
Forest Plot ◽  
Research Support ◽  
Phase 3

Background:The efficacy of the interleukin (IL)-23 subunit p19 inhibitor guselkumab (GUS) for psoriatic arthritis (PsA) has recently been demonstrated in two Phase 3 trials (DISCOVER-1 & -2) but has not been evaluated versus existing targeted therapies for PsA.Objectives:To compare GUS to targeted therapies for PsA through network meta-analysis (NMA).Methods:A systematic literature review was performed to identify PsA randomized controlled trials from 2000 to 2018. Bayesian NMAs were performed to compare treatments on American College of Rheumatology (ACR) 20/50/70 response, Psoriasis Area Severity Index (PASI) 75/90/100 response, Health Assessment Questionnaire Disability Index (HAQ-DI) score, resolution of enthesitis (RoE), resolution of dactylitis (RoD), adverse events (AEs) and serious adverse events (SAEs). Analyses used random effects models that adjusted for placebo response via meta-regression on baseline risk when feasible. Results are summarized by ranking treatments according to median absolute probabilities of response derived from NMAs.Results:Twenty-six Phase 3 studies were included in the quantitative synthesis. Studies were placebo-controlled up to 24 weeks and evaluated 13 targeted therapies for PsA. Absolute probabilities are reported for PASI 90 & ACR 20 responses according toFigure 1,and a forest plot of relative risks versus placebo for AEs is reported according toFigure 2. For ACR 20 response, GUS 100 mg every 4 weeks (Q4W) and every 8 weeks (Q8W) ranked 5th and 8th out of 20 interventions and were comparable to IL-17A inhibitor (IL-17Ai) and most tumor necrosis factor inhibitor (TNFi) agents. Similar findings were observed for ACR 50 and 70 responses. For PASI 90 response, GUS Q4W and Q8W ranked 1st and 2nd out of 15 interventions and were highly likely to provide a greater benefit than most other agents. Similar findings were observed for PASI 75 and 100 responses. For HAQ-DI score, GUS Q4W and Q8W ranked 6th and 10th out of 20 interventions and were comparable to IL-17Ai and most TNFi agents. For RoE, GUS Q4W and Q8W ranked 8th and 6th out of 13 interventions and were comparable to IL-17Ai and TNFi agents. For RoD, GUS Q4W and Q8W ranked 8th and 9th out of 13 interventions and were comparable to most IL-17Ai and TNFi agents. For AEs, GUS Q4W and Q8W ranked 3rd and 2nd out of 19 interventions and were comparable to IL-17Ai and TNFi agents. Likewise, for SAEs, GUS Q4W and Q8W ranked 4th and 5th out of 20 interventions and were comparable to IL-17Ai and TNFi agents. Analyses that controlled for previous exposure to biologics or assessed outcomes at alternative timepoints were broadly consistent with primary analysis results.Conclusion:NMA results indicate that GUS is comparable to most targeted PsA treatments for improvement in arthritis, soft tissue damage, physical function, and safety outcomes. For PASI outcomes, GUS is highly likely to provide a greater benefit than other targeted PsA treatments.Disclosure of Interests:Iain McInnes Grant/research support from: Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, Novartis, Pfizer, and UCB, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Kiefer Eaton Shareholder of: Test Pharma, Consultant of: Janssen, Agata Schubert Employee of: Janssen-Cilag, Steve Peterson Employee of: Janssen Research & Development, LLC, Tim Disher Consultant of: Janssen, Wim Noel Employee of: Janssen Pharmaceuticals NV, Hassan Fareen Employee of: Janssen, Chetan Karyekar Shareholder of: Johnson & Johnson, Consultant of: Janssen, Employee of: Janssen Global Services, LLC. Previously, Novartis, Bristol-Myers Squibb, and Abbott Labs., Suzy Van Sanden Employee of: Janssen, Christopher T. Ritchlin Grant/research support from: UCB Pharma, AbbVie, Amgen, Consultant of: UCB Pharma, Amgen, AbbVie, Lilly, Pfizer, Novartis, Gilead, Janssen, Wolf-Henning Boehncke Grant/research support from: Janssen Research & Development, LLC, Consultant of: Janssen

scholarly journals Systemic immunomodulatory treatments for atopic dermatitis: protocol for a systematic review with network meta-analysis

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e023061 ◽  
Author(s):  
Aaron Mark Drucker ◽  
Alexandra Ellis ◽  
Zarif Jabbar-Lopez ◽  
Zenas Z N Yiu ◽  
Bernd W M Arents ◽  
...  
Keyword(s):  
Systematic Review ◽  
Atopic Dermatitis ◽  
Adverse Events ◽  
Latin American ◽  
Meta Analysis ◽  
Scientific Journal ◽  
Health Science ◽  
Cochrane Central Register ◽  
Systemic Treatments ◽  
Patient Reported

IntroductionThere are numerous new systemic treatments for atopic dermatitis in various stages of development and most are being compared with placebo rather than active comparators. In order to understand the relative efficacy and safety of existing and new treatments for atopic dermatitis, robust mixed comparisons (ie, direct and indirect) would be beneficial. To address this gap, this protocol describes methods for a systematic review and network meta-analysis of systemic treatments for atopic dermatitis.Methods and analysisWe will update the search of a previous systematic review, including searches of the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Latin American and Caribbean Health Science Information database and the Global Resource of EczemA Trials database in addition to clinical trial protocol registries. Title, abstract and full paper screening as well as data extraction will be conducted in duplicate by independent researchers. Primary outcomes include efficacy with regards to clinician-reported signs and patient-reported symptoms and safety with regards to withdrawal from treatment due to adverse events and the occurrence of serious adverse events. Secondary outcomes will include change in quality of life and itch severity. Where possible and appropriate, network meta-analysis will be performed for each outcome using a random-effects model within a Bayesian framework. If appropriate, the review will be transitioned to a living review with continuous updating of the analysis.Ethics and disseminationDissemination in a peer-reviewed scientific journal is planned.PROSPERO registration numberCRD42018088112; Pre-results.

scholarly journals The short-term effectiveness of coronavirus disease 2019 (COVID-19) vaccines among healthcare workers: a systematic literature review and meta-analysis

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Alexandre R. Marra ◽  
Takaaki Kobayashi ◽  
Hiroyuki Suzuki ◽  
Mohammed Alsuhaibani ◽  
Bruna Marques Tofaneto ◽  
...  
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Healthcare Workers ◽  
Meta Analysis ◽  
Diagnostic Odds Ratio ◽  
Vaccine Effectiveness ◽  
Cochrane Central Register ◽  
Short Term ◽  
Central Register ◽  
Stratified Analysis

Abstract Objective: Healthcare workers (HCWs) are at risk of COVID-19 due to high levels of SARS-CoV-2 exposure. Thus, effective vaccines are needed. We performed a systematic literature review and meta-analysis on COVID-19 short-term vaccine effectiveness among HCWs. Methods: We searched PubMed, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials, Scopus, and Web of Science from December 2019 to June 11, 2021, for studies evaluating vaccine effectiveness against symptomatic COVID-19 among HCWs. To meta-analyze the extracted data, we calculated the pooled diagnostic odds ratio (DOR) for COVID-19 between vaccinated and unvaccinated HCWs. Vaccine effectiveness was estimated as 100% × (1 − DOR). We also performed a stratified analysis for vaccine effectiveness by vaccination status: 1 dose and 2 doses of the vaccine. Results: We included 13 studies, including 173,742 HCWs evaluated for vaccine effectiveness in the meta-analysis. The vast majority (99.9%) of HCWs were vaccinated with the Pfizer/BioNTech COVID-19 mRNA vaccine. The pooled DOR for symptomatic COVID-19 among vaccinated HCWs was 0.072 (95% confidence interval [CI], 0.028–0.184) with an estimated vaccine effectiveness of 92.8% (95% CI, 81.6%–97.2%). In stratified analyses, the estimated vaccine effectiveness against symptomatic COVID-19 among HCWs who had received 1 dose of vaccine was 82.1% (95% CI, 46.1%–94.1%) and the vaccine effectiveness among HCWs who had received 2 doses was 93.5% (95% CI, 82.5%–97.6%). Conclusions: The COVID-19 mRNA vaccines are highly effective against symptomatic COVID-19, even with 1 dose. More observational studies are needed to evaluate the vaccine effectiveness of other COVID-19 vaccines, COVID-19 breakthrough after vaccination, and vaccine efficacy against new variants.

scholarly journals Efficacy of Systemic Treatments of Nail Psoriasis: A Systemic Literature Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Xuan Zhang ◽  
Bingbing Xie ◽  
Yanling He
Keyword(s):  
Literature Review ◽  
Small Molecule ◽  
Effect Size ◽  
Meta Analysis ◽  
Systemic Review ◽  
Cochrane Central Register ◽  
Nail Psoriasis ◽  
Systemic Treatments ◽  
Random Control ◽  
Systemic Therapies

Importance: Nail involvement is a common condition in patients with psoriasis. The treatment of nail psoriasis is considered challenging and is often left untreated by physicians.Objective: To assess the efficacy of current systemic treatments on nail psoriasis.Data Sources: PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for relevant articles from inception to September 1, 2020. Included articles were restricted to English language and human studies.Study Selection: This was a systematic literature review with meta-analysis. Thirty-five random control trials that evaluated systemic therapies for nail psoriasis were selected in the systemic review. Among them, we retained 14 trials for meta-analysis.Data Extraction and Synthesis: This study was conducted in accordance with the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. All steps were performed by two independent investigators, and any disagreements were resolved by a third investigator. Meta-analysis of aggregated study data was conducted to assess therapeutic efficacy. The use of random-effects model was based on high heterogeneity as a variable endpoint in different studies.Main Outcomes and Measures: Therapeutic effects on nail psoriasis were expressed in terms of effect sizes with 95% CIs.Results: We included 35 random control trials (RCTs) in this systemic review. At baseline, a high prevalence (62.1%) of nail psoriasis was confirmed. The meta-analysis included 14 trials highlighting that biologic and small-molecule therapies were effective in treating nail psoriasis with variable effect size magnitudes [−0.89 (−1.10, −0.68), I2 = 84%]. In particular, tofacitinib and ixekizumab showed the most significant scale of effect size magnitudes in treating nail psoriasis (−1.08 points and −0.93 points, respectively). We also found that a higher dose of tofacitinib and ixekizumab had similar effectiveness, and anti-IL-17 agents seem to be superior in effectiveness compared to anti-TNF-α therapies in the treatment of nail psoriasis. However, these results must be displayed carefully as variable endpoints in different studies.Conclusions and Relevance: This study provides a comprehensive overview of systemic treatments for nail psoriasis. For patients with psoriatic nail damage who are candidates of systemic therapies, the priority should be given to administering biologic and small-molecule therapies, especially anti-IL-17 drugs.

scholarly journals Functional Outcome Measurement in Patients with Lower-Extremity Soft Tissue Sarcoma: A Systematic Literature Review

2019 ◽  
Vol 26 (13) ◽  
pp. 4707-4722 ◽  
Author(s):  
Gilber Kask ◽  
Ian Barner-Rasmussen ◽  
Jussi Petteri Repo ◽  
Magnus Kjäldman ◽  
Kaarel Kilk ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Literature Review ◽  
Lower Extremity ◽  
Functional Outcome ◽  
Systematic Literature Review ◽  
Outcome Measurement ◽  
Extremity Soft Tissue Sarcoma

scholarly journals Safe and Effective Treatment for Anemic Patients With Chronic Kidney Disease: An Updated Systematic Review and Meta-Analysis on Roxadustat

2021 ◽  
Vol 12 ◽  
Author(s):  
Mei Tang ◽  
Changyu Zhu ◽  
Ting Yan ◽  
Yanglin Zhou ◽  
Qin Lv ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Controlled Trial ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Hemoglobin Level ◽  
Oral Drug ◽  
Cochrane Central Register ◽  
Central Register

Background: Roxadustat is a new oral drug for anemia in chronic kidney disease (CKD). This study aimed to synthesize the evidence from randomized controlled trial (RCT)-based studies that estimated the efficacy and safety of roxadustat in anemia patients with non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD.Methods: We searched the PubMed, Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL) databases for related published studies. Moreover, we manually searched relevant pharmaceutical company websites and two international clinical trial registers to search for published and unpublished RCTs comparing roxadustat with erythropoietin-stimulating agents (ESAs) or placebo.Results: Fifteen RCTs (seven for DD-CKD patients, eight for NDD-CKD patients) were included in the meta-analysis, with 10,189 patients, 4,810 DD-CKD patients, and 5,379 NDD-CKD patients enrolled. Compared with ESAs (epoetin alfa or darbepoetin alfa) and placebo, roxadustat raised the hemoglobin level [weighted mean difference (WMD): 0.82 g/dL; 95% confidence interval (CI): 0.43–1.21], transferrin level (WMD: 0.5 g/L; 95% CI: 0.34–0.65), and TIBC level (WMD: 41.79 μg/dL; 95% CI: 38.67–44.92) and lowered the hepcidin level (WMD: −37.38 ng/ml; 95% CI: −46.63– −28.12) in both the DD-CKD and NDD-CKD patients with renal anemia. Roxadustat improved hemoglobin response and lowered the ferritin and TAST levels in the NDD-CKD patients but not in the DD-CKD patients. Furthermore, there was no difference between the treatment-emergent adverse events (TEAEs) of roxadustat and that of ESAs or placebo. But the incidence of serious TEAEs in the roxadustat group was significantly higher with NDD-CKD patients (OR: 1.15; 95% CI: 1.02–1.29).Conclusion: This study confirmed that roxadustat therapy could alleviate the anemia of DD-CKD and NDD-CKD patients by raising the hemoglobin level and regulating iron metabolism, but increased serious incidences of treatment-emergent adverse events (TEAEs) in NDD-CKD patients.

scholarly journals Assessment of Efficiency and Safety of Apatinib in Advanced Bone and Soft Tissue Sarcomas: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Zuoyao Long ◽  
Mengquan Huang ◽  
Kaituo Liu ◽  
Minghui Li ◽  
Jing Li ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Cochrane Library

BackgroundPrevious studies, both in vitro and in vivo, have established that apatinib has anti-tumor properties. However, insufficient empirical evidence of the efficacy and safety of apatinib has been published for bone and soft tissue sarcoma, the reported results differing widely. Here, we conducted a meta-analysis to assess the efficacy and toxicity of apatinib for the treatment of bone and soft tissue sarcoma.MethodsPubmed, Medline, Web of Science, ScienceDirect, Ovid, Embase, Cochrane Library, Scopus, Vip (China), Cnki (China), Wanfang (China), and CBM (China) databases and literature from conferences were searched for studies of apatinib for the treatment of bone and soft tissue sarcomas, published from the inception of each database to Sep 1, 2020, without language restrictions. Primary outcomes were efficacy and toxicity of apatinib for the treatment of bone and soft tissue sarcoma, including treatment response, progression-free survival (PFS), and the incidence of adverse events. After extraction of data and methodological quality evaluation, random or fixed-effects models, as appropriate, were selected to calculate pooled effect estimates using R software (Version 3.4.1).ResultsA total of 21 studies with 827 participants were included in the present meta-analysis. The mean MINORS score was 10.48 ± 1.75 (range: 7-13), indicating evidence of moderate quality. Pooled outcomes indicated that overall response rate (ORR) and disease control rate (DCR) were 23.85% (95% CI: 18.47%-30.21%) and 79.16% (95% CI: 73.78%-83.68%), respectively. Median PFS ranged from 3.5 to 13.1 months, with a mean of 7.08 ± 2.98 months. Furthermore, the rates of PFS (PFR) after 1, 6, and 12 months were 99.31%, 44.90%, and 14.31%, respectively. Drug-related toxicity appears to be common in patients administered apatinib, for which hand-foot syndrome (41.13%), hypertension (36.15%), and fatigue (20.52%) ranked the top three most common adverse events. However, the incidence of grade 3-4 adverse events was relatively low and manageable.ConclusionsBased on the best evidence currently available, apatinib demonstrates promising clinical efficacy and an acceptable safety profile for the treatment of advanced bone and soft tissue sarcoma, although additional high-quality clinical studies are required to further define its properties and toxicity.

Sign in / Sign up

Export Citation Format

Share Document