scholarly journals Comparative Efficacy and Safety of Dupilumab and Benralizumab in Patients with Inadequately Controlled Asthma: A Systematic Review

2020 ◽  
Vol 21 (3) ◽  
pp. 889 ◽  
Author(s):  
Koichi Ando ◽  
Akihiko Tanaka ◽  
Hironori Sagara

No head-to-head trials have compared the efficacy and safety between the licensed dosage and administration dosage of dupilumab and benralizumab for inadequately controlled asthma. We conducted an indirect treatment comparison to estimate differences in the efficacy and safety between dupilumab and benralizumab for inadequately controlled asthma using the Bayesian approach. The primary efficacy endpoint was annual exacerbation rate (AER). A subgroup analysis by blood eosinophil count was also performed. The primary safety endpoint was the incidence of any adverse events (AAEs). The results demonstrate that there was no significant difference in the AER between dupilumab and benralizumab in overall patients and the subgroup with the blood eosinophil count of <150. However, the AER was significantly lower in the dupilumab group than in the benralizumab group in the subgroup with a blood eosinophil count of ≥150 but <300, and ≥300 with the rate ratio and 95% credible interval of 0.51 (0.29–0.92) and 0.58 (0.39–0.84), respectively. There was no significant difference in the AAEs between the dupilumab and benralizumab groups. This indirect treatment comparison indicates that dupilumab is superior to benralizumab in patients with inadequately controlled asthma having higher blood eosinophil counts. A direct comparison is required to provide definitive evidence. Systematic Review Registration: UMIN-CTR no. UMIN000036256.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12570-e12570 ◽  
Author(s):  
Charles McCrea ◽  
Robert Hettle

e12570 Background: PARP inhibitor treatment with olaparib or talazoparib has been shown to improve progression-free survival (PFS) versus chemotherapy treatment of physician’s choice in patients with germline BRCA-mutated (gBRCA) HER2-negative metastatic breast cancer. In the absence of head-to-head evidence, an indirect treatment comparison (ITC) analysis was performed to simulate the comparative efficacy and safety of alternative PARP treatment in this setting. Methods: Bayesian fixed effects ITCs of data published for OlympiAD (NCT02000622) and EMBRACA (NCT01945775) was conducted using the gemtc package in R. Efficacy analyses were performed on the primary endpoint of PFS by blinded independent central review. Safety analyses included the odds ratio (OR) of adverse event (AE)-related discontinuations, and common AEs of any grade reported in each study. All analyses compared olaparib with talazoparib. Results: Efficacy analyses show no significant difference in PFS across treatments (PFS hazard ratio of 1.09, 95% credible interval [0.72; 1.65]). Safety analyses predict differences in AEs across PARP treatment, including hematological events, alopecia, nausea and vomiting (Table). No difference in AE-related discontinuations was observed (0.93 [0.25–3.42]). Conclusions: Results of the ITC suggest that olaparib and talazoparib are equally efficacious on PFS, and differ in AE risk profile, with olaparib predicted to have fewer common hematological and alopecia events, but an increased risk of nausea and vomiting versus talazoparib. Observed differences require confirmation in comparative studies. Limitations of the analysis include heterogeneity in study design, reporting of AEs, and mix of chemotherapies used in the control arm of the studies. [Table: see text]


Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 118-LB
Author(s):  
PHILIP HOME ◽  
ROOPA MEHTA ◽  
KHADIJA HAFIDH ◽  
OLESYA GUROVA ◽  
AGUSTINA ALVAREZ ◽  
...  

2018 ◽  
Vol 16 ◽  
pp. 147997231879026 ◽  
Author(s):  
Wen Li ◽  
Zhong Qin ◽  
Jie Gao ◽  
Zhibin Jiang ◽  
Yihui Chai ◽  
...  

Non-cystic fibrosis (non-CF) bronchiectasis is a condition characterized by an airway inflammatory response to bacterial pathogens. Frequent exacerbations have a major influence on the quality of life. Macrolide antibiotics have not only antibacterial but also immune-regulation effects. It is proved that macrolides have a benefit in preventing exacerbations. However, it is still uncertain whether azithromycin or erythromycin is more effective and safe. The purpose of this study was to answer the following question: Which kind of macrolide antibiotic is more effective and safe in preventing non-CF bronchiectasis exacerbation? We conducted a systematic review to identify randomized clinical trials published up to May 2017 that reported on macrolides for non-CF bronchiectasis and an adjusted indirect treatment comparison (AITC) between macrolides to evaluate their efficacy and safety. The direct comparison meta-analysis found that macrolides decreased the rate of exacerbation of non-CF bronchiectasis (risk ratio (RR) = 0.45; 95% confidence interval (CI) 0.36–0.55) with heterogeneity ( I2 = 63.7%, p = 0.064). The AITC showed that azithromycin had a significantly lower bronchiectasis exacerbation rate than erythromycin (RR = 0.35; 95% CI: 0.403–0.947). Azithromycin increased the risk of diarrhea and abnormal pain. This meta-analysis suggested that long-term treatment with macrolides significantly reduced the incidence of non-CF bronchiectasis exacerbation. Moreover, azithromycin is more efficient than roxithromycin and erythromycin in preventing exacerbation.


2019 ◽  
Vol 143 (1) ◽  
pp. 190-200.e20 ◽  
Author(s):  
William Busse ◽  
Geoffrey Chupp ◽  
Hiroyuki Nagase ◽  
Frank C. Albers ◽  
Scott Doyle ◽  
...  

Author(s):  
Xin Hu ◽  
Shuli Qu ◽  
Xingxing Yao ◽  
Chaoyun Li ◽  
Yanjun Liu ◽  
...  

Abstract Background To conduct an indirect treatment comparison of patients with high-volume mHSPC and a cost analysis between Abi-ADT and Doc-ADT therapies in China. Methods The Bucher technique for indirect treatment comparison was used. A cost analysis was conducted from both healthcare and patient perspectives. Results The indirect treatment comparison demonstrated no significant difference in PFS for Abi-ADT versus Doc-ADT (HR: 0.84, 95% CI 0.66–1.07). Doc-ADT therapy costs less than Abi-ADT, with potential savings of up to RMB 887,057 per patient from the healthcare perspective and RMB 226,210 per patient from the patient perspective. Conclusions No significant differences in PFS between Doc-ADT and Abi-ADT therapy for patients with high-volume mHSPC. Doc-ADT therapy is a cost-saving alternative to Abi-ADT in China.


2018 ◽  
Vol 51 (5) ◽  
pp. 1702523 ◽  
Author(s):  
Marc Humbert ◽  
Camille Taillé ◽  
Laurence Mala ◽  
Vincent Le Gros ◽  
Jocelyne Just ◽  
...  

Omalizumab is a monoclonal anti-IgE antibody used to treat severe allergic asthma (SAA). The aim of the STELLAIR study was to determine the importance of pre-treatment blood eosinophil count as a predictive measure for response to omalizumab.This retrospective real-life study was conducted in France between December 2015 and September 2016 using medical records of SAA omalizumab-treated patients. Response to omalizumab was assessed by three criteria: physician evaluation, reduction of ≥40% in annual exacerbation rate and a combination of both. Response rate was calculated according to blood eosinophil count measured in the year prior to omalizumab initiation.872 SAA omalizumab-treated patients were included by 78 physicians (723 adults (age ≥18 years) and 149 minors (age 6–17 years)). Blood eosinophil count was ≥300 cells·µL−1 in 52.1% of adults and 73.8% of minors. By physician evaluation, 67.2% of adults and 77.2% of minors were responders and 71.1% adults and 78.5% minors had a ≥40% reduction in the exacerbation rate. In adults, the response rate for combined criteria was 58.4% (95% CI 53.2–63.4%) for blood eosinophils ≥300 cells·µL−1 (n=377) and 58.1% (95% CI 52.7–63.4%) for blood eosinophils <300 cells·µL−1 (n=346).This study shows that a large proportion of patients with SAA have a blood eosinophil count ≥300 cells·µL−1, and suggests that omalizumab effectiveness is similar in “high” and “low” eosinophil subgroups.


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