Video transcript
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CLINICAL EFFICACY
PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.
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AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE, ADJUVANTED)
Audio
Results from this pivotal study demonstrated that efficacy of AREXVY in patients 60 years and older, including patients with at least 1 comorbidity... results also showed efficacy by RSV type, severity, and age.
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Baseline Characteristics Were Balanced Between Study Groups (Exposed Population)1
[chart]
Characteristic: Mean age, years
AREXVY (n=12,467)*: 69.5 ±6.5
Placebo (n=12,499)*: 69.6 ±6.4
Characteristic: Age category, n (%)
60-69 years
AREXVY (n=12,467)*: 6963 (55.9)
Placebo (n=12,499)*: 6980 (55.8)
Characteristic: Age category, n (%)
70-79 years
AREXVY (n=12,467)*: 4487 (36.0)
Placebo (n=12,499)*: 4491 (35.9)
Characteristic: Age category, n (%)
≥80 years
AREXVY (n=12,467)*: 1017 (8.2)
Placebo (n=12,499)*: 1028 (8.2)
Characteristic: Female, n (%)
AREXVY (n=12,467)*: 6488 (52.0)
Placebo (n=12,499)*: 6427 (51.4)
Characteristic: Race, n (%)†
White
AREXVY (n=12,467)*: 9887 (79.3)
Placebo (n=12,499)*: 9932 (79.5)
Characteristic: Race, n (%)†
Black or African American
AREXVY (n=12,467)*: 1064 (8.5)
Placebo (n=12,499)*: 1101 (8.8)
Characteristic: Race, n (%)†
Asian
AREXVY (n=12,467)*: 953 (7.6)
Placebo (n=12,499)*: 956 (7.6)
Characteristic: Race, n (%)†
Other
AREXVY (n=12,467)*: 563 (4.5)
Placebo (n=12,499)*: 510 (4.1)
Characteristic: Comorbidity of interest, n (%)
Any pre-existing condition
AREXVY (n=12,467)*: 4937 (39.6)
Placebo (n=12,499)*: 4864 (38.9)
Characteristic: Comorbidity of interest, n (%)
Cardiorespiratory pre-existing condition
AREXVY (n=12,467)*: 2496 (20.0)
Placebo (n=12,499)*: 2422 (19.4)
Characteristic: Comorbidity of interest, n (%)
Endocrine or metabolic pre-existing condition
AREXVY (n=12,467)*: 3200 (25.7)
Placebo (n=12,499)*: 3236 (25.9)
*The exposed population included all the participants who received a single dose of AREXVY or placebo. Standard deviation in mean age is indicated by ± values. Percentages may not total 100 because of rounding.
†Race was reported by the participant.
COPD=chronic obstructive pulmonary disease; RSV=respiratory syncytial virus.
~39% of participants in each group had ≥1 pre-existing comorbidity of interest associated with an increased risk of severe RSV disease.
Comorbidities of interest: COPD, asthma, any chronic respiratory or pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.
1. Papi A, Ison MG, Langley JM, et al. N Engl J Med. 2023;388:595-608.
PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.
Audio
When you look at the demographic characteristics of the participants, it's similar in both groups.
So, the mean age of the participants were 69 1/2, and at baseline 39% of participants had at least 1 comorbidity of interest. Let's talk about those comorbidities of interest again -- COPD, asthma, any chronic respiratory disease, chronic heart failure, diabetes, advanced liver disease, or advanced renal disease. So, these baseline characteristics were balanced between the 2 study groups, and I think that's important.
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Exceptional Efficacy for Patients Aged 60 Years and Older1
PRIMARY ENDPOINT
82.6% OVERALL EFFICACY AGAINST RSV-LRTD (96.95% CI, 57.9, 94.1)
AREXVY (7 cases out of 12,466), placebo (40 cases out of 12,494)
The primary population for efficacy analysis (referred to as the modified exposed set) included adults aged 60 years and older receiving 1 dose of AREXVY or placebo and who did not report and RSV-confirmed acute respiratory illness (ARI) prior to Day 15 after vaccination.
Participants received 1 dose of AREXVY (n=12,466) or placebo (n=12,494).
At the time of the primary efficacy analysis, participants had been followed for the development of RSV-associated LRTD for up to 10 months (median of 6.7 months).
LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.
1. Prescribing Information for AREXVY.
PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.
Audio
When you look at the efficacy for patients who are 60 and over, we had an 82.6% overall efficacy against RSV lower respiratory tract disease. So, the primary study objective was met. The median follow-up was 6.7 months.
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Exceptional Efficacy in Patients With Certain Comorbidities1
SECONDARY ENDPOINT
94.6% EFFICACY AGAINST RSV-LRTD in participants aged 60 years and older with at least 1 comorbidity* (95% CI, 65.9, 99.9)
AREXVY (1 case out of 4937), placebo (18 cases out of 4861)
PRIMARY ENDPOINT†:
82.6% overall efficacy against RSV-LRTD (96.95% CI, 57.9, 94.1)
*Comorbidities of interest: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory or pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.
†AReSVi-006, an ongoing phase 3 study, randomized participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). RSV-LRTD was reported in 7 participants in the AREXVY group vs 40 in the placebo group. Median follow-up for this analysis was 6.7 months.
LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.
1. Prescribing Information for AREXVY.
PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.
Audio
When you look even further, let's look at the patients that had comorbidities. I'm talking about the patients with chronic lung disease, chronic heart disease, advanced liver disease, advanced renal disease. Let's look at this specific efficacy.
Efficacy indicates reduced risk of developing RSV-associated lower respiratory tract disease. In this group of individuals, we reduced that risk by 94.6% in those participants who were 60 and older with 1 comorbidity of interest.
I talked about these comorbidities of interest earlier.
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Efficacy by RSV Type, Severity, and Age
RSV-LRTD BY SUBTYPES
84.6% Efficacy against RSV A-LRTD1 (95% CI, 32.1, 98.3)
80.9% Efficacy against RSV B-LRTD1 (95% CI, 49.4, 94.3)
SEVERE RSV-LRTD
94.1% Efficacy against severe RSV-LRTD1 (95% CI, 62.4, 99.9)
AREXVY (1 case out of 12,466), placebo (17 cases out of 12,494)
SUBGROUP ANALYSIS FOR PARTICIPANT’S AGE*
81.0% Efficacy against RSV-LRTD in participants aged 60-69 years1 (95% CI, 43.6, 95.3)
AREXVY (4 cases out of 6963), placebo (21 cases out of 6979)
93.8% Efficacy against RSV-LRTD in participants aged 70-79 years1 (95% CI, 60.2, 99.9)
AREXVY (1 case out of 4487), placebo (16 cases out of 4487)
*The vaccine efficacy in the subgroup of participants 80 years of age and older (1016 participants who received AREXVY vs 1028 participants who received placebo) cannot be concluded due to the low number of total cases accrued (2 cases among participants who received AREXVY and 3 cases among participants who received placebo).1
RSV=respiratory syncytial virus.
1. Prescribing Information for AREXVY.
PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.
Audio
When you look at the efficacy by RSV type, severity, and age, here's what you get for efficacy for 60 and up for RSV-A LRTD. 84.6%. For RSV-B, 80.9%. With severe RSV-LRTD at 94.1%.
And then in these subgroup analyses, these individuals are first age 60-69, 81% efficacy for these individuals. Individuals who were 70-79, the efficacy was higher -- 93.8% for these individuals.
The vaccine efficacy in the subgroup of participants 80 years of age and older could not be concluded due to the low number of total cases accrued.
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Intended for US healthcare professionals only.
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RSAVID230040 July 2023
Produced in USA.
Please see Important Safety Information and full Prescribing Information available on this website.
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