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Background Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy but is associated with local and systemic reactions. This study assessed the impact of RZV on the quality of life and daily functioning of participants and implications for caregivers. Methods Four hundred and one adults aged 50 years or older received single RZV doses at 0 and 2 months in this open-label, single-arm, multicenter study (NCT02979639). Change in mean SF-36 Physical Functioning score following first-dose administration, quality of life, reactogenicity, safety, productivity loss, and health care resource utilization was assessed. The current analysis was performed post-vaccine dose-1; safety follow-up will continue until 1 year post-dose-2. Results The most common solicited local symptoms were injection-site pain (77.5%), redness (23.0%), and swelling (13.3%); the most frequent solicited systemic reactions were fatigue (33.5%), headache (28.3%), and myalgia (26.8%). Grade 3 reactogenicity occurred in 9.5% of participants and was associated with a transient clinically important decrease in SF-36 Physical Functioning score (affecting activities such as walking, carrying groceries, climbing stairs) on Days 1 and 2 post-first vaccination. No clinically meaningful reductions in mean SF-36 Physical Functioning scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary end point), and no overall quality-adjusted-life-year loss was recorded post-dose-1. Five participants reported lost workdays; caregiver workload was not increased. Conclusions Overall, the physical functioning and quality of life of older adults were not affected by a first RZV dose. The observed reactogenicity was consistent with previous studies.

Semaglutide, a glucagon-like peptide-1 analog for the once-weekly treatment of type 2 diabetes, provided superior glycemic control and weight loss (WL) vs. comparators in the SUSTAIN clinical trial program. This post hoc analysis assessed if WL was associated with patient-reported health-related quality of life (HRQoL) and treatment satisfaction improvements in SUSTAIN 2-5 and 7. Data for both semaglutide doses (0.5 and 1.0 mg) were pooled across trials (N=2,808). Change in HRQoL (Short Form-36 Health Survey version 2® [SF-36v2®] Physical Component Summary [PCS] and Mental Component Summary) and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire status version) scores were evaluated in subjects who achieved ≥5% and ≥10% WL vs. those who did not at end of treatment (30, 40 or 56 weeks). Overall, 51.0% and 17.4% of subjects achieved ≥5% and ≥10% WL with semaglutide. Significantly greater improvements in the overall PCS score and most of its components were reported in subjects achieving ≥5% and ≥10% WL vs. those not achieving these responses (Table). WL responses also correlated with overall treatment satisfaction and perception of hyperglycemia (Table). In conclusion, semaglutide-induced WL was associated with improvements in PCS domains of the SF-36v2®, overall treatment satisfaction and perception of hyperglycemia across the SUSTAIN 2-5 and 7 trials. Disclosure K.T. Uusinarkaus: Advisory Panel; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc. Speaker's Bureau; Self; Amarin Corporation, Amgen Inc., Regeneron Pharmaceuticals, Sanofi US. Stock/Shareholder; Self; Abbott, AbbVie Inc., Amarin Corporation, Pfizer Inc. H.W. Rodbard: Advisory Panel; Self; Bayer US, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Consultant; Spouse/Partner; Eli Lilly and Company. Consultant; Self; Gan & Lee Pharmaceuticals. Research Support; Self; Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; Merck & Co., Inc., Novo Nordisk Inc. L. Van Gaal: Advisory Panel; Self; Janssen Pharmaceuticals, Inc., Johnson & Johnson. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Servier. J.P. Wilding: Consultant; Self; Astellas Pharma Europe Ltd., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, NAPP Pharmaceuticals Limited, Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Novo Nordisk A/S. Speaker's Bureau; Self; Eli Lilly and Company, WebMD. T. Hansen: None. A. Sandberg: Employee; Self; Novo Nordisk A/S. S. Tadayon: Employee; Self; Novo Nordisk A/S. M.J. Davies: Advisory Panel; Self; Eli Lilly and Company, Janssen Global Services, LLC., Novo Nordisk A/S, Sanofi-Aventis, Servier. Research Support; Self; Boehringer Ingelheim International GmbH, Novo Nordisk Foundation. Speaker's Bureau; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. Funding Novo Nordisk A/S

Aim: To investigate treatment satisfaction with semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, versus placebo/active comparators in the SUSTAIN clinical trial programme. Methods: In SUSTAIN 2–5 and 7, the Diabetes Treatment Satisfaction Questionnaire was used to evaluate patient-perceived treatment satisfaction, hyperglycaemia and hypoglycaemia. Post hoc subgroup analyses were conducted to explore the effects of gastrointestinal adverse events (GI AEs), weight loss (≥5%) or achieving glycaemic (HbA1c < 7%) targets on treatment satisfaction. Results: Overall treatment satisfaction increased from baseline to end of treatment with all treatments across trials. Improvements were significantly greater with semaglutide versus comparators/placebo in SUSTAIN 2–5 (all P < 0.05), and generally greater in patients who achieved versus did not achieve weight loss and glycaemic targets, often with greater improvements with semaglutide 1.0 mg versus comparator/placebo in both weight loss groups. In SUSTAIN 7, improvements in overall treatment satisfaction were generally similar between semaglutide and dulaglutide, irrespective of weight loss or glycaemic control. In SUSTAIN 7, changes in overall treatment satisfaction score were generally lower in patients with versus without GI AEs at week 16 (except dulaglutide 0.75 mg), but similar by week 40. Perceived hyperglycaemia was significantly reduced from baseline to end of treatment with semaglutide versus all comparators/placebo (all P < 0.05). No differences between treatments were observed for perceived hypoglycaemia. Conclusions: Semaglutide was associated with significantly greater (SUSTAIN 2–5) or similar (SUSTAIN 7) improvements in overall treatment satisfaction versus comparators/placebo. Improvements in overall treatment satisfaction were generally greater in patients achieving versus not achieving treatment targets. Clinicaltrials.gov: NCT01930188 (SUSTAIN 2), NCT01885208 (SUSTAIN 3), NCT02128932 (SUSTAIN 4), NCT02305381 (SUSTAIN 5) and NCT02648204 (SUSTAIN 7). EudraCT: 2012–004827-19 (SUSTAIN 2), 2012–004826-92 (SUSTAIN 3), 2013–004392-12 (SUSTAIN 4), 2013–004502-26 (SUSTAIN 5) and 2014–005375-91 (SUSTAIN 7).

Background Herpes zoster (HZ) and its related complications are associated with a significant burden of illness in older adults, which negatively impacts patients’ physical functioning and quality-of-life (QoL). The recombinant zoster vaccine (RZV) shows high efficacy for the prevention of HZ in older adults but is associated with local and systemic reactions. Therefore, this study assessed the impact of RZV reactogenicity upon the physical functioning and QoL of participants. Methods 401 adults aged ≥50 years received a dose of RZV at 0 and 2 months in this open-label, single-arm, multicenter study (NCT02979639). Changes in mean SF-36 Physical Functioning score were assessed between pre-dose-1 vaccination and post-dose-1 vaccination for 7 days (primary endpoint). Decreased scores are associated with decreased physical functioning. QoL, reactogenicity and safety were also assessed. The current analysis was performed post-dose-1 vaccination of the 2-dose RZV schedule. Results No clinically meaningful reductions in overall mean SF-36 Physical Functioning scores from pre- to post-RZV dose-1 were observed (mean +1.9 points) and no overall quality-adjusted-life-year loss was recorded post-dose-1. However, grade 3 reactogenicity occurred in 9.5% of participants, and was associated with a transient, clinically-important decrease in SF-36 Physical Functioning score (impacting activities such as walking, carrying groceries, climbing stairs) on Days 1–2 post-first-vaccination (Table 1). The solicited local symptoms were pain (77.5%), redness (23.0%) and swelling (13.3%); the most frequent solicited systemic reactions were fatigue (33.5%), headache (28.3%) and myalgia (26.8%). Conclusion Overall, the physical functioning and QoL of older adults were not significantly affected by a first RZV dose. Grade 3 reactogenicity was associated with a small transient decrease in physical functioning 1–2 days post-dose-1 that resolved by Day 3 post-vaccination. Funding: GlaxoSmithKline Biologicals SA Disclosures K. E. Schmader, GSK group of companies: Investigator, Research grant. M. J. Levin, GSK group of companies: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. K. Grupping, GSK group of companies: Employee, Salary. S. Matthews, GSK group of companies: Consultant, Consulting fee. M. El Idrissi, GSK group of companies: Employee and Shareholder, Salary. L. A. Fissette, GSK group of companies: Employee, Salary. C. Fogarty, Medical Research: Investigator, Research grant. N. P. Klein, GSK group of companies: Investigator, Research support. M. Nevarez, GSK group of companies: Investigator, Investigator stipend. K. Uusinarkaus, GSK group of companies: Investigator, Research grant. L. Oostvogels, GSK group of companies: Employee, Salary. D. Curran, GSK group of companies: Employee and Shareholder, GSK shares and Salary.