Indirect Treatment Comparisons of Lefamulin Versus Omadacycline for the Treatment of Community-Acquired Pneumonia

Speaker(s)

Wu M1, Ding J1, Han S2, Li H3
1Sumitomo Pharma (Suzhou) Co., Ltd., Shanghai, China, 2International Research Center of Medical Administration, Peking University, Beijing, China, 3China Pharmaceutical University, Nanjing, Jiangsu, China

Presentation Documents

OBJECTIVES: Lefamulin (LEF) and Omadacycline (OMA) are both novel antibiotics approved for the treatment of community-acquired pneumonia (CAP) in China. This study aims to indirectly compare the efficacy and safety of LEF and OMA in treating CAP in the absence of head-to-head trial data.

METHODS: Eligible studies were identified via a systematic literature review and Cochrane Risk of Bias 2 (RoB2) was used for quality assessment. An indirect treatment comparison (ITC) was conducted to assess the outcomes including early clinical response (ECR), investigator-assessed clinical response (IACR) at test of cure and safety profile. Various subgroup analyses were also performed.

RESULTS: Three randomized clinical trials (RCTs) involving 2,063 patients were identified. All included RCTs were assessed as low risk of bias. Comparable efficacy of ECR (RR=1.01, 95%CI 0.93-1.09) and IACR (RR=0.95, 95%CI 0.88-1.02) was found between LEF and OMA. Both LEF and OMA are well-tolerated in treatment of CAP. LEF showed numerically lower mortality rate compared to OMA group (RR=0.67, 95%CI 0.15-3.02) (No treatment-related deaths were observed in LEF group, while no information was provided in OMA group).

In subgroups analysis, LEF showed numerically superior to OMA regarding ECR and IACR in patients aged 65 years or older, with moderate renal impairment, with history of diabetes mellitus, and with most of the CAP typical and atypical pathogens, though there were not statistically significant. Besides, LEF showed significantly superior to OMA regarding IACR in patients with Haemophilus influenzae (RR=1.28, 95% CI 1.03-1.60).

CONCLUSIONS: LEF and OMA have comparable efficacy and safety in treating CAP patients. LEF appears to be a promising therapy option with a potentially lower risk of death. Further analysis of subgroups suggests that LEF may improve clinical outcomes for elderly patients, those with renal impairment, comorbidities, or specific pathogens.

Code

CO111

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Drugs, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)