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Clinical Trial
. 2023 Aug 1;39(8):386-393.
doi: 10.1097/AJP.0000000000001129.

An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies

Sean Matthews  1 , Desmond Curran  2 , Eliazar Sabater Cabrera  2 , Céline Boutry  2 , Nicolas Lecrenier  2 , Anthony L Cunningham  3 , Kenneth Schmader  4
Affiliations
Clinical Trial

An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies

Sean Matthews et al. Clin J Pain. .

Abstract

Objectives: Herpes zoster (HZ) is a painful condition caused by the reactivation of the varicella-zoster virus, negatively affecting the lives of patients. In this post hoc analysis, we describe the impact of HZ pain on the health-related quality of life (HRQoL) and activities of daily living (ADL) of immunocompetent individuals 50 years of age and older and in hematopoietic stem cell transplantation (HSCT) recipients age 18 years of age and older.

Materials and methods: ZOE-50 (NCT01165177), ZOE-70 (NCT01165229), and ZOE-HSCT (NCT01610414) were phase III, randomized studies conducted in immunocompetent adults 50 years of age and older and 70 years of age and older and in HSCT recipients age 18 years of age and older, respectively. This analysis was performed on patients who experienced an HZ episode in the placebo groups. The impact of varying levels of HZ pain on HRQoL and ADL was analyzed using data from the Zoster Brief Pain Inventory (ZBPI) and the Short Form Health Survey 36 (SF-36) and EQ-5D questionnaires.

Results: A total of 520 immunocompetent and 172 HSCT individuals with HZ were included. SF-36 and EQ-5D domain scores showed a significant relationship between increased HZ pain and worsening HRQoL. For every increase of 1 in the ZBPI pain score, the estimated mean decrease (worsening) in score in the ZOE-50/70 and ZOE-HSCT, respectively, was 2.0 and 2.4 for SF-36 Role Physical; 2.1 and 1.8 for SF-36 Social Functioning; and 0.041 and 0.045 for EQ-5D utility. Sleep and General activities were the ADL components most affected.

Discussion: Moderate and severe HZ pain had a substantial negative impact on all aspects of HRQoL and ADL. This impact was independent of age and immunosuppression.

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Conflict of interest statement

GlaxoSmithKline Biologicals SA (Brentford, United Kingdom) funded this study (GSK study identifiers: 110390, 113077) and was involved in all stages of study conduct, including the analysis of the data. GlaxoSmithKline Biologicals SA also took charge of all costs associated with the development and publication of this article. C.B., D.C., E.S.C., and N.L. are employed by/hold shares in GSK. A.L.C. reports a grant from GSK and received honoraria paid to his institution Merck Serono (Merck, Darmstadt, Germany), and BioCSL/Sequirus (Melbourne, Australia) outside the submitted work. S.M. reports personal fees from GSK during the conduct of the study and outside the submitted work. N.L. reports patents planned, issued, or pending outside the submitted work. The remaining authors declare no conflict of interest.

Figures

None
Graphical abstract
FIGURE 1
FIGURE 1
SF-36 Domain Scores by corresponding ZBPI Worst Pain Category at day 0 and day 14 of HZ episode. ZOE-50/70 and ZOE-HSCT. ZOE-50/70=Placebo participants from the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) studies who had an HZ episode. ZOE-HSCT=Placebo participants from the ZOE-HSCT study (NCT01610414) who had an HZ episode. SF-36=Short Form Survey 36, ZBPI=Zoster Brief Pain Inventory. Pain categories: No Pain=ZBPI Worst pain score=0; Mild Pain=ZBPI pain score=1, 2, 3; Moderate Pain=ZBPI pain score=4, 5, 6, 7; Severe Pain=ZBPI pain score=8, 9, 10. N=Number of participants with a baseline (pre-HZ episode) SF-36 questionnaire and an SF-36 and ZBPI questionnaire at the relevant time point during the HZ episode. HSCT indicates hematopoietic stem cell transplantation; HZ, herpes zoster.
FIGURE 2
FIGURE 2
Change from baseline in EQ-5D Utility Score during HZ episode by corresponding ZBPI Worst Pain Category and time point. ZOE-50/70 ZOE-HSCT. ZOE-50/70=Placebo participants from the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) studies who had an HZ episode. ZOE-HSCT=Placebo participants from the ZOE-HSCT study (NCT01610414) who had an HZ episode. EQ-5D=EuroQoL EQ-5D. Pain categories: None=ZBPI Worst pain score=0; Mild Pain=ZBPI pain score=1, 2, 3; Moderate Pain=ZBPI pain score=4, 5, 6, 7; Severe Pain=ZBPI pain score=8, 9, 10. N=Number of participants with a baseline (pre-HZ episode) EQ-5D utility assessment and both an EQ-5D utility and ZBPI worst pain score assessed at the relevant time point during the HZ episode. HSCT indicates hematopoietic stem cell transplantation; HZ, herpes zoster; ZBPI, Zoster Brief Pain Inventory.
FIGURE 3
FIGURE 3
ZBPI ADL components at day 0 by Worst Pain Score. ZOE-50/70=Placebo participants from the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) studies who had an HZ episode. ZOE-HSCT=Placebo participants from the ZOE-HSCT study (NCT01610414) who had an HZ episode. ADL indicates activities of daily living; HSCT, hematopoietic stem cell transplantation; HZ, herpes zoster; N, number of participants by ZBPI worst pain score at day 0; ZBPI, Zoster Brief Pain Inventory.
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