23. ZOE-50 and ZOE-70 Placebo Groups Data Shows that Burden of Pain Associated with Herpes Zoster Interferes with Activities of Daily Living

Abstract

Abstract Background Adults ≥ 50 years of age (YOA) are at increased risk of herpes zoster (HZ), a condition which can cause long-term pain and discomfort. In this analysis, we assessed the burden of pain associated with HZ and its interference with activities of daily living (ADL) in patients ≥ 50 YOA. Methods ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) were phase III, observer-blind, placebo-controlled, 1:1 randomized studies in adults ≥ 50 YOA (ZOE-50) and ≥ 70 YOA (ZOE-70) who received 2 doses of the adjuvanted recombinant zoster vaccine or placebo, 2 months apart. To correctly evaluate HZ pain, the analysis was performed only on the placebo groups data of ZOE-50 (≥ 50 YOA) and pooled ZOE-50/70 (≥ 70 YOA pooled data) in the modified total vaccinated cohort (mTVC, primary population for efficacy analysis) HZ-confirmed cases. HZ pain and interference with ADL was assessed by the Zoster Brief Pain Inventory (ZBPI) instrument completed daily by patients for the first 28 days and then weekly until resolution. Time to resolution of clinically significant pain was analyzed using Kaplan Meier methods. We estimated the cumulative area under curve (AUC) of the ZBPI worst pain score and the ZBPI ADL score up to 182 days post-HZ rash onset. A high AUC reflects a higher severity/longer duration of pain. Results Overall, 254 patients ≥ 50 YOA and 284 patients ≥ 70 YOA were included in the mTVC HZ-confirmed cases for the ZOE-50 and ZOE-70 pooled analysis, respectively. In HZ patients ≥ 50 YOA, 94.6% reported any pain (ZBPI pain score > 0), 87.6% clinically significant pain (ZBPI pain score ≥ 3) and 65.1% severe pain (ZBPI pain score ≥ 7). Similarly, in HZ patients ≥ 70 YOA, 93.2% reported any pain, 90.9% clinically significant pain and 68.4% severe pain. It was estimated that 11.6% and 18.3% of patients aged ≥ 50 and ≥ 70 YOA, respectively, had clinically significant pain 3 months after the onset of HZ. The mean AUC at 182 days was 137.24 (≥ 50 YOA) and 190.68 (≥ 70 YOA), for the ZBPI worst pain score and 92.75 (≥ 50 YOA) and 130.89 (≥ 70 YOA), for the ZBPI ADL score. Conclusion Analysis of data provided by patients with confirmed HZ shows that the burden of HZ pain is high and is associated with interference on patients’ ADL. Funding GlaxoSmithKline Biologicals SA Acknowledgment M Maior/S Hulsmans provided medical writing/editorial support (Modis c/o GSK) Disclosures Eliazar Sabater Cabrera, MSc, GSK (Employee, Shareholder) Desmond Curran, PhD, The GSK group of companies (Employee, Shareholder) Sean Matthews, MSc, GSK (Independent Contractor) Céline Boutry, PhD, GSK (Employee) Nicolas Lecrenier, Ing, PhD, The GSK group of companies (Employee, Shareholder) Anthony L. Cunningham, F.A.H.M.S., MD, M.B.B.S., B. Med. Sci. (Hons), F.R.A.C.P., F.R.C.P.A., F.A.S.M., GSK group of companies (Grant/Research Support, Advisor or Review Panel member, Speaker’s Bureau)