1. I MPACT OF H ERPES Z OSTER O PHTHALMICUS ON Q UALITY OF L IFE AND A GE - RELATED F UNCTIONAL D ECLINE A BSTRACT / P OSTER ID # 10991 Marc LABETOULLE Ophthalmology Department, Bicêtre Hospital, South Paris University, Gif/Yvette, France E-mail: marc.labetoulle@bct.aphp.fr

2. The author of this presentation has received reimbursement and fees for advisory boards or speakers bureau from Alcon, Allergan, Bausch & Lomb, Sanofi Pasteur MSD, Santen, Thea 2 C ONFLICTS OF I NTEREST

3. Herpes Zoster (HZ) is a painful and debilitating disease, which incidence and severity increase with age. Whereas the burden of Post Herpetic Neuralgia (PHN), its main complication, has been evaluated in several studies, the specific impact of Herpes Zoster Ophthalmicus (HZO) on health-related quality of life (HR-QoL) and functional decline has been poorly studied. A study is needed to assess the impact of HZO in elderly patients 3 P URPOSE

4. To present the rationale of this study To describe its planned design 4 O BJECTIVE

5. A multidisciplinary group performed a narrative analysis of the literature on the relationship between HZ (HZO incl.) and functional decline. Multidisciplinary group (by alphabetic order): Nadine ATTAL, Neurologist, Pain Specialist, Paris Claire DEBACK, Virologist, Paris Gaétan GAVAZZI, Geriatrician, Grenoble Marc LABETOULLE, Ophthalmologist, Paris François LIARD, General practitioner, Saint-Epain Philip GORWOOD, Psychiatrist, Paris Gisèle PICKERING, Pharmacologist, Pain Specialist, Clermont- Ferrand 5 M ETHODS

6. Varicella-Zoster-Virus (VZV) is a human α-herpesvirus. VZV establishes life-long latency after initial infection. HZ results from reactivation of VZV. In Europe, almost all adults have had varicella (mainly during their childhood) and can potentially suffer from HZ. Waning of VZV-specific cell-mediated immunity associated with the normal aging process (immunosenescence) is the key-risk factor for reactivation of VZV and HZ development [1]. It has been estimated that 1 in 4 people will develop HZ during their lifetime, and up to 1 in 2 people among 85+. Several studies have clearly shown that the incidence and severity of HZ and PHN (i.e., pain continuing 90 days or longer after the rash onset) increase with age 6 H ERPES Z OSTER (HZ) [1] Arvin A. N Engl J Med 2005;352:2266-7

7. HZO occurs with reactivation of VZV in the ophthalmic division of the trigeminal nerve. HZO represents ≈ 10% of all HZ cases [1]. At least 50% of patients with HZO will have direct ocular impairment (e.g., conjunctivitis, keratitis, uveitis, optic neuritis, retinal necrosis). HZ-associated eye complications require an average of 10 months of medical care with 7% of cases resulting in vision loss [2]. 7 H ERPES Z OSTER O PHTHALMICUS (HZO) [1] Kawai K. BMJ Open 2014; [2] Yawn BP. Mayo Clin Proc 2013;88:562–70

8. Functional decline is defined by reduced ability to perform everyday activities. Functional decline is enhanced with age, comorbidities, and infections (such as HZ) [1]. 8 F UNCTIONAL D ECLINE [1] McElhaney JE Expert Rev Vaccines 2010;9:27–30

9. Several studies have clearly shown that HZ and PHN, dramatically impairs HR-QoL and functional status [1, 2]. HZO has a poor prognosis, with short and long-term sequelae, including chronic ocular inflammation, visual loss, and disabling pain. In addition to the risk for ocular complications, HZO may be associated with increased risk of severe pain, PHN, and possibly fatal strokes within 1 year [3]. 9 B URDEN OF THE D ISEASE [1] Oxman MN. N Engl J Med 2005;352[22]:2271-84; [2] Bouhassira D. Pain 2012;153:342-49; Lin HC. Neurology 2010;74:792-7.

10. Objectives Primary objectives To assess the impact of HZ, regardless of its localization, on HR-QoL in patients aged 50 years and over after the diagnosis of acute using generic (EQ-5D) and specific (ZBPI) instruments. To assess the impact of HZO on HR-QoL with specific ophthalmic impact scales (NEI VFQ 25, OSD-QoL) Secondary objectives To describe evolution of scores regarding timing, severity of the disease, age of patient, pain intensity, chronic ophthalmologic complications, treatments 10 D ESIGN OF QUALIPZO S TUDY (Q UALITY OF L IFE IN P ATIENTS WITH H ERPES Z OSTER )

11. Patients (≈ 800 patients with HZ, ≈ 80 patients with HZO) ≥ 50 years of age Diagnosis of acute HZ on D0 Provided written informed consent Investigators ≈ 1,500 general practitioners (GPs), selected in 2 groups: GPs who have been active investigators in the ARIZONA* study [1] ≈ 2,000 GPs aware of the disease and representative of the French GPs population GPs of the “Sentinelles” network (INSERM) = GPs aware of the disease Study flow chart 11 D ESIGN OF QUALIPZO S TUDY (Q UALITY OF L IFE IN P ATIENTS WITH H ERPES Z OSTER ) [1] Bouhassira D. Pain 2012;153:342-49. D-15 EQ-5D ZBPI NEI VFQ 25 OSD-QoL EQ-5D ZBPI NEI VFQ 25 OSD-QoL EQ-5D ZBPI NEI VFQ 25 OSD-QoL D0M3M12 EQ-5D ZBPI NEI VFQ 25 OSD-QoL

12. This study will provide specific data on HZ impact on HR-QoL in patients aged 50 years and over with a specific focus on HZO. Keywords: Ageing; Functional decline; Herpes Zoster Ophthalmicus; Keratitis; Pain 12 C ONCLUSION World Cornea Congress VII – San Diego 2015 - Abstract & Poster # 10991