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Infliximab as a Second-Line Therapy for Children with Refractory Kawasaki Disease; A Systematic Review and Meta-analysis of Randomized Controlled Trials
Kabbaha S, Milano A, Aldeyab MA, Thorlund K
British journal of clinical pharmacology. 2022
Abstract
AIM: Infliximab is a tumor necrosis factor-alpha inhibitor that is being used to treat children with refractory Kawasaki disease. Our purpose was to evaluate the safety and the impact of infliximab versus intravenous immunoglobulins on the incidence of coronary artery aneurysms (CAAs) and treatment resistance in children with refractory Kawasaki disease (KD). METHODS The Medline/PubMed, Embase, CINAHL, Cochrane Central Register of Controlled Trials and clinical trials registries were searched to December 2021. Randomized controlled trials (RCTs) comparing infliximab as second-line therapy to a second dose of intravenous immunoglobulin (IVIG) in children with refractory KD, reported in abstract or full text were included. Studies were selected and assessed for risk of bias by two reviewers. Data were extracted and pooled using conventional random-effects meta-analysis. The certainty of evidence was assessed using the GRADE system. RESULTS A total of 199 participants from 4 RCTs were included. Pooled risk ratio (RR) for the incidence of treatment resistance in patients treated with infliximab was RR=0.40 (95% CI 0.25-0.64). For incidence of CAAs RR was 1.20 (95% CI 0.54-2.63), the incidence of adverse effect 'infusion reactions' RR=0.48, (95% CI 0.12-1.92), and 'infections' RR=0.55 (95% CI 0.27-1.12). Overall, the GRADE strength of evidence for the primary outcomes was low. Evidence on the duration of fever and inflammatory biomarkers was sparse, heterogeneous, and inconclusive. CONCLUSION Moderate-certainty evidence indicates that infliximab may reduce the incidence of treatment resistance in children with refractory KD. However, the limited strength of evidence warrants further research.
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2.
Integrative treatment of herbal medicine with western medicine on coronary artery lesions in children with Kawasaki disease
Choi J, Chang S, Kim E, Min SY
Medicine. 2022;101(7):e28802
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Abstract
BACKGROUND Kawasaki disease (KD) is a major cause of coronary artery lesions (CALs) in children. Approximately 10% to 20% of children treated with intravenous immunoglobulin are intravenous immunoglobulin-resistant. This study evaluated the efficacy and safety of adding herbal medicine to conventional western medicines versus conventional western medicines alone for CALs in children with KD. METHODS This study searched 9 electronic databases until August 31, 2021. The inclusion criteria were the randomized controlled trials (RCTs) that assessed the CALs in children with KD and compared integrative treatment with conventional western treatments. Two authors searched independently for RCTs, including eligible articles that fulfilled the inclusion criteria, extracted data, and assessed the methodological quality using the Cochrane risk of bias tool. Meta-analysis was conducted using Cochrane Collaboration's Review Manager 5.4 software. The effect size was presented as the risk ratio (RR), and the fixed-effect models were used to pool the results. RESULTS The finally selected 12 studies included a total of 1030 KD patients. According to a meta-analysis, the integrative treatment showed better results than the conventional treatment in the CAL prevalence rate (RR = 2.00; 95% confidence interval [CI], 1.49-2.71; P < .00001), CAL recovery rate (RR = 1.27; 95% CI, 1.05-1.54; P = .02), and total effective rate (RR = 1.17; 95% CI, 1.11-1.23; P < .00001). Only 2 studies referred to the safety of the treatment. The asymmetrical funnel plot of the CAL prevalence rate indicated the possibility of potential publication bias. CONCLUSIONS This review found the integrative treatment to be more effective in reducing the CAL prevalence rate and increasing the CAL recovery rate and total effective rate in KD patients than conventional western treatment. However, additional well-designed RCTs will be needed further to compensate restrictions of insufficient trials on safety, methodological quality, and publication bias.
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Characteristics, treatment, and outcomes of Myasthenia Gravis in COVID-19 patients: A systematic review
Abbas AS, Hardy N, Ghozy S, Dibas M, Paranjape G, Evanson KW, Reierson NL, Cowie K, Kamrowski S, Schmidt S, et al
Clinical neurology and neurosurgery. 2022;213:107140
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Abstract
OBJECTIVE Recent studies suggest that the clinical course and outcomes of patients with coronavirus disease 2019 (COVID-19) and myasthenia gravis (MG) are highly variable. We performed a systematic review of the relevant literature with a key aim to assess the outcomes of invasive ventilation, mortality, and hospital length of stay (HLoS) for patients presenting with MG and COVID-19. METHODS We searched the PubMed, Scopus, Web of Science, and MedRxiv databases for original articles that reported patients with MG and COVID-19. We included all clinical studies that reported MG in patients with confirmed COVID-19 cases via RT-PCR tests. We collected data on patient background characteristics, symptoms, time between MG and COVID-19 diagnosis, MG and COVID-19 treatments, HLoS, and mortality at last available follow-up. We reported summary statistics as counts and percentages or mean±SD. When necessary, inverse variance weighting was used to aggregate patient-level data and summary statistics. RESULTS Nineteen studies with 152 patients (mean age 54.4 ± 12.7 years; 79/152 [52.0%] female) were included. Hypertension (62/141, 44.0%) and diabetes (30/141, 21.3%) were the most common comorbidities. The mean time between the diagnosis of MG and COVID-19 was7.0 ± 6.3 years. Diagnosis of COVID-19 was confirmed in all patients via RT-PCR tests. Fever (40/59, 67.8%) and ptosis (9/55, 16.4%) were the most frequent COVID-19 and MG symptoms, respectively. Azithromycin and ceftriaxone were the most common COVID-19 treatments, while prednisone and intravenous immunoglobulin were the most common MG treatments. Invasive ventilation treatment was required for 25/59 (42.4%) of patients. The mean HLoS was 18.2 ± 9.9 days. The mortality rate was 18/152 (11.8%). CONCLUSION This report provides an overview of the characteristics, treatment, and outcomes of MG in COVID-19 patients. Although COVID-19 may exaggerate the neurological symptoms and worsens the outcome in MG patients, we did not find enough evidence to support this notion. Further studies with larger numbers of patients with MG and COVID-19 are needed to better assess the clinical outcomes in these patients.
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Higher Efficacy of Infliximab than Immunoglobulin on Kawasaki Disease, a Meta-analysis
Li X, Tang Y, Ding Y, Chen Y, Hou M, Sun L, Qian G, Qin L, Lv H
European journal of pharmacology. 2021;:173985
Abstract
This meta-analysis evaluated the efficacy and safety of infliximab as initial therapy for patients with Kawasaki disease (KD) and intravenous immunoglobulin (IVIG) resistant KD.Studies of infliximab in KD, published between January 2004 and December 2019, were curated from PubMed, MEDLINE, and Cochrane Library. Data were analyzed using STATA Version 12.0. Of the 8 studies considered, 4 evaluated the effect of infliximab combined with IVIG as primary therapy in KD, and the remaining investigated the effect of infliximab in IVIG resistant patients. Infliximab was more effective than the control group, with the total summary odds ratio (OR) of 0.34 (95% confidence interval (CI): 0.19-0.62). The treatment resistance of the infliximab group was lower than the IVIG group (0.36 [95% CI: 0.14-0.92]) when infliximab was combined with IVIG as the initial treatment. However, infliximab treatment for IVIG resistant KD was more effective than the IVIG group (0.28 [95% CI: 0.12-0.66]). There was no significant increase in the incidence of coronary artery lesions. The total summary OR for the incidence of coronary artery lesions and infliximab treatment was 0.88 (95% CI: 0.48-1.62). There was no statistically significant difference in adverse events (AEs) when compared between the groups (0.71 [95% CI: 0.44-1.16]).Infliximab combined with IVIG reduced treatment resistance in KD patients vs. conventional IVIG therapy. Infliximab improved clinical course in IVIG resistant KD patients. Infliximab treatment did not reduce the incidence of coronary artery lesions and did not show any significant increase in the incidence of AEs. PROSPERO REGISTRATION NUMBER CRD42020218554.
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Thrombopoietin receptor agonists and rituximab for treatment of pediatric immune thrombocytopenia: A systematic review and meta-analysis of prospective clinical trials
Ayad N, Grace RF, Al-Samkari H
Pediatric blood & cancer. 2021;:e29447
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Editor's Choice
Abstract
BACKGROUND Children with immune thrombocytopenia (ITP) may require second-line ITP therapies. The high remission rate in pediatric patients, need for extended-duration use of thrombopoietin receptor agonists (TPO-RAs), drug adherence, potential side effects, monitoring, and cost effectiveness are factors that should be considered in decision-making about second-line therapies. Rituximab (RTX) has been used off-label for years to treat ITP but there are limited studies about its efficacy and safety in children. To date, no studies have directly compared TPO-RAs with RTX for the treatment of childhood ITP. METHODS This systematic review analyzed the overall platelet response, durability of treatment effect, and safety for RTX use in comparison to TPO-RAs in pediatric ITP. MEDLINE/PubMed, EMBASE, Cochrane Library, and Web of Science databases were searched through December 2020 and meta-analysis was conducted using proportions of success/failure for each intervention in the selected studies. RESULTS The proportion of participants achieving the primary endpoint of a platelet response above 50,000 was similar for TPO-RAs (proportion = 0.71, 95% CI: 0.63-0.78) and RTX (proportion = 0.68, 95% CI: 0.53-0.82). However, considerable variation was found between the two groups with regards to the sustainability of the response and other secondary outcomes such as need for rescue and adverse events. RTX was associated with higher rates of rescue therapy. CONCLUSIONS In this analysis of prospective pediatric ITP studies, RTX and TPO-RAs had similar rates of overall platelet response but differed in other important measures. Prospective comparative studies are needed to better characterize second-line treatments for pediatric ITP.
PICO Summary
Population
Children with immune thrombocytopenia lasting 6 months or longer, and enrolled in randomised controlled trials (RCTs) and non-randomised studies, identified by systematic review (n= 498, 6 RCTs, 5 non-randomised studies).
Intervention
Thrombopoietin receptor agonists (TPO-Ras).
Comparison
Rituximab (RTX).
Outcome
The proportion of participants achieving the primary endpoint of a platelet response above 50,000 was similar for TPO-RAs (proportion= 0.71, 95% CI: 0.63-0.78) and RTX (proportion= 0.68, 95% CI: 0.53-0.82). However, considerable variation was found between the two groups with regards to the sustainability of the response and other secondary outcomes such as need for rescue and adverse events. RTX was associated with higher rates of rescue therapy.
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The Efficacy of High-Dose Dexamethasone vs. Other Treatments for Newly Diagnosed Immune Thrombocytopenia: A Meta-Analysis
Xiao Q, Lin B, Wang H, Zhan W, Chen P
Frontiers in medicine. 2021;8:656792
Abstract
Objective: To compare the therapeutic efficacies of high dose dexamethasone, prednisone and rituximab in combination with dexamethasone for newly diagnosed ITP (Immune Thrombocytopenia, ITP) patients. Methods and results: Relevant publications for this study were obtained by searching PubMed, Embase, Cochrane, and CNKI (National Knowledge Infrastructure, CNKI) databases following the PRISMA guidelines. A total of, 15 publications were retrieved that contained sufficient data from 1,362 patients for high quality analysis of this study endpoints. Data analysis was carried out using Stata 11.0 software. The primary outcomes were OR (Overall Response, OR) at 1 month after intervention and SR at 6 and 12 months. The secondary outcomes were AEs and relapse. There were no differences in the OR, while the SR was higher at 6 months (p = 0.001) as well as 12 months (p < 0.001) in the rituximab + dexamethasone group. In addition, the incidences of AEs (p = 0.008) were also higher in the rituximab + dexamethasone group. Dexamethasone was superior to prednisone based on OR (p = 0.006). We found no differences in SR at 6 months between dexamethasone and prednisone but SR at 12 months was higher in the dexamethasone group (p = 0.014). The relapse rate was higher in the high dose dexamethasone group compared to the rituximab + dexamethasone group (p = 0.042). Conclusion: This demonstrated that new treatment options such as Rituximab + dexamethasone, could be a good alternative to traditional therapy in improving long-term response and reducing the rate of relapse. However, further studies are required on the increased risk of AEs associated with Rituximab + dexamethasone.
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Indirect-comparison meta-analysis of treatment options for patients with refractory Kawasaki disease
Chan H, Chi H, You H, Wang M, Zhang G, Yang H, Li Q
BMC pediatrics. 2019;19(1):158
Abstract
BACKGROUND There is limited information available regarding the clinical management of intravenous immunoglobulin-resistant Kawasaki disease (KD). We aimed to evaluate the optimal treatment options for patients with refractory KD by presenting an indirect-comparison meta-analysis. METHODS PubMed, EMBASE, Web of Science, and the Cochrane Database were searched on August 31, 2018. Unpublished studies were also searched in ProQuest Dissertations & Theses and through manual retrieval strategies. Randomized concurrent controlled trials (RCTs), high-quality non-randomized concurrent controlled trials (non-RCTs), and retrospective studies associated with AEs were included. The quality of all eligible studies was assessed using Cochrane collaboration's tool and non-randomized study guidelines. Risk ratios (RR) with 95% confidence intervals (CIs) for dichotomous outcomes were estimated in our analysis. GRADE profiler 3.6.1 was used to assess the evidence profile. RESULTS Twelve studies involving 372 immunoglobulin-resistant KD patients were identified and analyzed. Neither infliximab nor intravenous pulse methylprednisolone (IVMP) was significantly more effective than second IVIG infusion with respect to lowering coronary artery lesions (CALs) (infliximab, 0.85, 0.43-1.69; IVMP, 0.99, 0.52-1.88) and treatment resistance (infliximab, 0.43, 0.21-0.89; IVMP, 1.16, 0.33-4.13). No significant differences were found between infliximab and IVMP in the incidence rate of CALs (0.70, 0.27-1.81), the treatment resistance (0.37, 0.09-1.60), the rates of coronary artery aneurysm (4.13, 0.38-45.22) and the coronary artery dilatation (0.45, 0.10-1.99). Furthermore, compared with second IVIG infusion, both infliximab and IVMP showed significant effectiveness in antipyretic effects (infliximab, 1.52, 1.16-1.99; IVMP, 1.29, 0.77-2.15). However, Infliximab was noninferior to IVMP on antipyretic effects (1.18, 0.66-2.15). IVMP treatment showed significant association with fewer AEs than second IVIG infusion (0.49, 0.26-0.94) and infliximab (2.34, 1.07-5.09). No significant differences were noted between infliximab treatment and second IVIG infusion (1.06, 0.69-1.63). CONCLUSIONS Infliximab, IVMP, and second IVIG infusion showed no significant differences in the cardioprotective effect or the rate of treatment resistance. Infliximab and IVMP treatment were more effective than second IVIG infusion regarding antipyretic effects. IVMP treatment may have an advantage due to its lower total rate of AEs associated with drug infusion. TRIAL REGISTRATION The study has been registered on PROSPERO ( CRD42016039693 ).
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Efficacy and safety of thrombopoietin receptor agonists in children with chronic immune thrombocytopenic purpura: meta-analysis
Tumaini Massaro J, Chen Y, Ke Z
Platelets. 2019;:1-8
Abstract
Immune thrombocytopenic purpura (ITP) is an autoimmune disorder presenting with low platelet count <100 x 10(9)/L. The condition affects both adults and children. Thrombopoietin receptor agonists (TPO-RAs) are second-line of therapy that includes Romiplostim and Eltrombopag, which stimulate the production of normally functioning platelets. Although the biological effect of these drugs is well established, there has not been a meta-analysis in children. To estimate the efficacy and safety of Romiplostim and Eltrombopag, we performed a systematic review and meta-analysis in children with chronic ITP. Systematic literature search was conducted in the following database: PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). Review Manager 5.3 for Windows was used to analyze the data. Five randomized controlled trials with total of 261 pediatric patients from 1-17 years of age were included. The efficacy and safety analysis showed TPO-RA groups were superior over placebo, and there was no difference in adverse event occurrence between TPO-RA (Romiplostim and Eltrombopag) and placebo groups. The efficacy and safety of Eltrombopag did not differ significantly from those of Romiplostim. Both drugs were effective in treatment of children with chronic ITP. Our findings extend the currently available data on ITP treatment and is helpful for pediatric health providers and for the design of future clinical trials.
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Meta-analysis for efficacy of Romiplostim for treatment of immune idiopathic thrombocytopenia
Aggarwal S, Topaloglu H, Messenger M
Value in Health. 2013;16((3):):A112-3.
