Impact of Herpes Zoster and Post-Herpetic Neuralgia on Health-Related Quality of Life in Japanese Adults Aged 60 Years or Older: Results from a Prospective, Observational Cohort Study

Clinical Drug Investigation, Oct 2017

Background and Objectives Herpes zoster (HZ) and its most frequent complication, post-herpetic neuralgia (PHN), have been shown to considerably impact quality of life (QoL). This has not yet been demonstrated in Japan. Methods QoL in HZ and PHN patients was evaluated using the Zoster Brief Pain Inventory (ZBPI), EuroQoL-5 Dimension (EQ-5D), Short-Form 12 version 2.0, and short-form McGill Pain Questionnaire up to 270 days after rash onset as part of a prospective, observational, cohort study conducted in Kushiro, Hokkaido, Japan. Results This study involved 412 adults ≥ 60 years of age diagnosed with HZ, 38 of whom developed PHN. QoL in daily activity performance and emotional and physical functioning was impaired at Day 0 (rash onset) and almost resolved by Day 90. Although the mean ZBPI worst pain score for HZ patients without PHN improved from 4.1 at Day 0 to 0.1 at Day 90, the score for HZ patients with PHN at Day 90 was comparable to that for HZ patients without PHN at Day 0. While the EQ-5D score in HZ without PHN improved, on average, from 0.755 to 0.949, the score for HZ with PHN was dependent on PHN duration and did not improve until PHN disappearance. Conclusions HZ impaired QoL in daily activity performance and emotional and physical functioning. The negative impact on QoL was more prevalent in patients with a longer PHN duration compared with HZ without PHN. ClinicalTrials.gov identifier: NCT01873365.

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Impact of Herpes Zoster and Post-Herpetic Neuralgia on Health-Related Quality of Life in Japanese Adults Aged 60 Years or Older: Results from a Prospective, Observational Cohort Study

Impact of Herpes Zoster and Post-Herpetic Neuralgia on Health- Related Quality of Life in Japanese Adults Aged 60 Years or Older: Results from a Prospective, Observational Cohort Study Akiko Mizukami 0 1 2 3 Keiko Sato 0 1 2 3 Koichi Adachi 0 1 2 3 Sean Matthews 0 1 2 3 Katsiaryna Holl 0 1 2 3 Taizo Matsuki 0 1 2 3 Toshihiko Kaise 0 1 2 3 Desmond Curran 0 1 2 3 0 Kushiro Dermatology Clinic , Hokkaido , Japan 1 Development and Medical Affairs Division, GSK K.K , GSK Bldg. 6-15, Sendagaya 4-chome, Shibuya-ku, Tokyo 151-8566 , Japan 2 & Akiko Mizukami 3 Health Economics Department , GSK, Wavre , Belgium Background and Objectives Herpes zoster (HZ) and its most frequent complication, post-herpetic neuralgia (PHN), have been shown to considerably impact quality of life (QoL). This has not yet been demonstrated in Japan. Methods QoL in HZ and PHN patients was evaluated using the Zoster Brief Pain Inventory (ZBPI), EuroQoL-5 Dimension (EQ-5D), Short-Form 12 version 2.0, and shortform McGill Pain Questionnaire up to 270 days after rash onset as part of a prospective, observational, cohort study conducted in Kushiro, Hokkaido, Japan. Results This study involved 412 adults C 60 years of age diagnosed with HZ, 38 of whom developed PHN. QoL in daily activity performance and emotional and physical functioning was impaired at Day 0 (rash onset) and almost resolved by Day 90. Although the mean ZBPI worst pain score for HZ patients without PHN improved from 4.1 at Day 0 to 0.1 at Day 90, the score for HZ patients with PHN at Day 90 was comparable to that for HZ patients without PHN at Day 0. While the EQ-5D score in HZ without PHN improved, on average, from 0.755 to 0.949, the score for HZ with PHN was dependent on PHN duration and did not improve until PHN disappearance. - Akiko Mizukami and Keiko Sato are co-first authors on this work. 1 Introduction Herpes zoster (HZ) occurs when varicella-zoster virus (VZV) reactivates due to waning of cell-mediated immunity. More than 90% of the Japanese population is infected with VZV by 20 years of age or older [ 1 ] and therefore have a 30% lifetime risk of HZ [ 2 ]. HZ-related pain resolves by approximately 90 days for many patients with HZ, but approximately 20% of them will develop postherpetic neuralgia (PHN) [ 3 ], debilitating, long-lasting pain that can continue for months or years and which therefore requires long-term pain management. Annually, approximately 500,000 individuals in Japan aged 60 years or older develop HZ [ 3, 4 ], and this number is expected to increase due to aging of the population, with an expected increase in the number of patients aged C 60 years from 40 million (32%) in 2012 to 45 million (41%) by 2050 [5]. Even with treatment, HZ patients may experience pain for a prolonged period of time [ 6 ], and almost half of HZ patients aged over 70 years were shown to experience pain persisting for more than 1 year [ 7 ]. Indeed, the risk of HZ recurrence increases with age [ 8 ]. A number of studies in different countries reported a significant negative impact of HZ and PHN on patients’ quality of life (QoL) and that pain experienced due to the disease interfered with many aspects of the patient’s daily life [ 9–11 ]. In addition, the presence of PHN was associated with a greater impact on most domains of QoL [ 12–15 ]. However, to date, data on QoL in HZ patients are very limited in Japan [16]. Cultural differences have been known in patient-reported outcomes across countries [ 14, 17 ]. Whether similarity or difference in the outcomes is observed in Japan compared with other countries is not known. The present study assessed the impact of HZ and PHN on the QoL of adults aged 60 years or older in Japan. 2 Subjects and Methods 2.1 Study Design The QoL data were collected as part of a prospective, observational, multicenter, physician practice-based cohort study of people aged 60 years or older conducted in Kushiro, Japan, between June 2013 and February 2015. The details of the study have been published elsewhere [ 18 ]. Study participants were recruited among patients presenting at seven dermatology clinics or hospitals, and HZ was diagnosed by the physician at the initial consultation or at a subsequent visit within 7 days of the initial visit. The maximal duration of the study for each patient was 270 days from the initial visit. At 90 and 180 days after the initial visit, patients with a pain score of 0 were considered as having completed the study. PHN was defined by the presence of HZ-associated pain rated as C 3 in response to item 3 of the Zoster Brief Pain Inventory (ZBPI) questionnaire [ 19 ], persisting or appearing more than 90 days after onset of the HZ rash. Only HZ patients who were considered to comply with the protocol requirements (e.g. complete the booklets by themselves) were included in the study. The study is registered at ClinicalTrials.gov (NCT01873365). It was conducted in accordance with the Ethic (...truncated)


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Akiko Mizukami, Keiko Sato, Koichi Adachi, Sean Matthews, Katsiaryna Holl, Taizo Matsuki, Toshihiko Kaise, Desmond Curran. Impact of Herpes Zoster and Post-Herpetic Neuralgia on Health-Related Quality of Life in Japanese Adults Aged 60 Years or Older: Results from a Prospective, Observational Cohort Study, Clinical Drug Investigation, 2017, pp. 1-9, DOI: 10.1007/s40261-017-0581-5