Expert opinion on drug safety · 2026
A systematic review and meta-analysis of safety and efficacy parameters of sotatercept in the therapy of pulmonary arterial hypertension.
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Dutta Siddhartha, Shah Rima, Singhal Shubha, Singh Mamta, Dholariya Sagar, Chawla Shalini, Katoch Chandan
Аннотация
INTRODUCTION: Pulmonary arterial hypertension (PAH) has responded favorably to the new fusion protein named sotatercept. This study aimed to evaluate the safety and efficacy of sotatercept in PAH.
METHODS: The online databases like PubMed/Medline, Cochrane Library, and ClinicalTrials.gov were searched until 15 September 2024 for studies comparing sotatercept to placebo using keywords such as "sotatercept, pulmonary arterial hypertension, and 'fusion protein.'
RESULTS: Of the 213 titles searched, after removing duplicates, 142 studies were evaluated for eligibility. Two RCTs were finally included. Subgroup analysis was conducted for the two doses (0.7 mg/kg and 0.3 mg/kg). In the safety analysis, there were no significant differences in total adverse events [RR = 1.03 (0.95, 1.12), I2 = 0, p = 0.50], serious adverse events [RR = 0.96 (0.38, 2.42), I2 = 56, p = 0.93], and mortality [RR = 0.39 (0.01, 11.81), I2 = 61%, p = 0.59]. However, a significant difference was observed with non-serious adverse events [RR = 1.15 (1.03-1.30), I2 = 0%, p = 0.02], telangiectasia [RR = 3.34 (1.26-8.83), p = 0.02], thrombocytopenia [RR = 3.69 (1.23-11.0), I2 = 0%, p = 0.02] and epistaxis [RR = 5.58 (2.20-14.13), p = 0.0003]. No significant difference was observed with headache, nasopharyngitis, hypotension, neutropenia, nausea, diarrhea, rash, anemia, and dizziness. A significant change was observed with the majority of efficacy parameters, like Pro BNP [MD = -1150.38 (-1846.44, -454.32), I2 = 79, p = 0.001], pulmonary vascular resistance [MD = -234.40 (-325.30, -143.51), I2 = 72, p < 0.00001], pulmonary arterial wedge pressure (p = 0.007) and improvement in WHO functional class [OR = 3.23 (1.25, 8.34), I2 = 61, p = 0.02].
CONCLUSION: This study demonstrates that sotatercept is more effective than placebo in treating PAH and has a fair safety profile.
CLINICALTRIAL.GOV: Identifier numbers: NCT04576988 and NCT03496207 PROSPERO: CRD42024534695.
METHODS: The online databases like PubMed/Medline, Cochrane Library, and ClinicalTrials.gov were searched until 15 September 2024 for studies comparing sotatercept to placebo using keywords such as "sotatercept, pulmonary arterial hypertension, and 'fusion protein.'
RESULTS: Of the 213 titles searched, after removing duplicates, 142 studies were evaluated for eligibility. Two RCTs were finally included. Subgroup analysis was conducted for the two doses (0.7 mg/kg and 0.3 mg/kg). In the safety analysis, there were no significant differences in total adverse events [RR = 1.03 (0.95, 1.12), I2 = 0, p = 0.50], serious adverse events [RR = 0.96 (0.38, 2.42), I2 = 56, p = 0.93], and mortality [RR = 0.39 (0.01, 11.81), I2 = 61%, p = 0.59]. However, a significant difference was observed with non-serious adverse events [RR = 1.15 (1.03-1.30), I2 = 0%, p = 0.02], telangiectasia [RR = 3.34 (1.26-8.83), p = 0.02], thrombocytopenia [RR = 3.69 (1.23-11.0), I2 = 0%, p = 0.02] and epistaxis [RR = 5.58 (2.20-14.13), p = 0.0003]. No significant difference was observed with headache, nasopharyngitis, hypotension, neutropenia, nausea, diarrhea, rash, anemia, and dizziness. A significant change was observed with the majority of efficacy parameters, like Pro BNP [MD = -1150.38 (-1846.44, -454.32), I2 = 79, p = 0.001], pulmonary vascular resistance [MD = -234.40 (-325.30, -143.51), I2 = 72, p < 0.00001], pulmonary arterial wedge pressure (p = 0.007) and improvement in WHO functional class [OR = 3.23 (1.25, 8.34), I2 = 61, p = 0.02].
CONCLUSION: This study demonstrates that sotatercept is more effective than placebo in treating PAH and has a fair safety profile.
CLINICALTRIAL.GOV: Identifier numbers: NCT04576988 and NCT03496207 PROSPERO: CRD42024534695.