Trial Outcomes & Findings for Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy (NCT NCT01772160)
NCT ID: NCT01772160
Last Updated: 2020-05-22
Results Overview
A case of HZ was defined as new unilateral pain (broadly defined to include allodynia and pruritus) accompanied by unilateral rash and no alternative diagnosis. Age ranges were 50-54, 55-59, 60-64, 65-69, 70-74, 75-79 and greater than or equal to (≥) 80 years. The incidence rate was expressed as the number of HZ cases per (/) 1000 person-years.
COMPLETED
395 participants
Day 0 to 2 years
2020-05-22
Participant Flow
Out of 395 subjects originally enrolled in this study, 1 subject was excluded due to protocol violation, hence only 394 were included in the Total Cohort.
Participant milestones
| Measure |
Herpes Zoster Group
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Overall Study
STARTED
|
394
|
|
Overall Study
COMPLETED
|
346
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
| Measure |
Herpes Zoster Group
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Eligibility criteria not fulfilled
|
3
|
|
Overall Study
Consent withdrawal
|
3
|
|
Overall Study
Migrated / moved from the study area
|
4
|
|
Overall Study
Lost to Follow-up
|
30
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Herpes Zoster Group
n=394 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Age, Continuous
|
69.3 Years
STANDARD_DEVIATION 11.0 • n=394 Participants
|
|
Sex: Female, Male
Female
|
238 Participants
n=394 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=394 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 2 yearsPopulation: The analysis was performed on the HZ cases occurring in the total population covered by the participating general practitioners (GPs).
A case of HZ was defined as new unilateral pain (broadly defined to include allodynia and pruritus) accompanied by unilateral rash and no alternative diagnosis. Age ranges were 50-54, 55-59, 60-64, 65-69, 70-74, 75-79 and greater than or equal to (≥) 80 years. The incidence rate was expressed as the number of HZ cases per (/) 1000 person-years.
Outcome measures
| Measure |
Herpes Zoster Group
n=721 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Female, 50-54
|
5.19 Number of HZ cases/1000 person-years
Interval 3.84 to 6.86
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Female, 55-59
|
6.29 Number of HZ cases/1000 person-years
Interval 4.75 to 8.17
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Female, 60-64
|
5.00 Number of HZ cases/1000 person-years
Interval 3.55 to 6.83
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Female, 65-69
|
9.19 Number of HZ cases/1000 person-years
Interval 7.22 to 11.54
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Female, 70-74
|
7.51 Number of HZ cases/1000 person-years
Interval 5.64 to 9.79
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Female, 75-79
|
10.72 Number of HZ cases/1000 person-years
Interval 8.37 to 13.52
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Female, ≥ 80
|
7.06 Number of HZ cases/1000 person-years
Interval 5.69 to 8.65
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Male, 50-54
|
1.71 Number of HZ cases/1000 person-years
Interval 0.96 to 2.82
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Male, 55-59
|
2.91 Number of HZ cases/1000 person-years
Interval 1.85 to 4.37
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Male, 60-64
|
4.35 Number of HZ cases/1000 person-years
Interval 2.98 to 6.15
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Male, 65-69
|
8.95 Number of HZ cases/1000 person-years
Interval 6.86 to 11.47
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Male, 70-74
|
9.33 Number of HZ cases/1000 person-years
Interval 7.05 to 12.12
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Male, 75-79
|
7.18 Number of HZ cases/1000 person-years
Interval 5.1 to 9.81
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Male, ≥ 80
|
7.20 Number of HZ cases/1000 person-years
Interval 5.48 to 9.29
|
|
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
Overall incidence of HZ cases
|
6.46 Number of HZ cases/1000 person-years
Interval 5.99 to 6.95
|
SECONDARY outcome
Timeframe: At Day 90, 180 and 270 after onset of HZPopulation: The analysis was performed on the HZ cases (with completed questionnaires up to Day 270) occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
PHN persistence refers to pain occurring or persisting from Day 90 to Day 270 after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.
Outcome measures
| Measure |
Herpes Zoster Group
n=343 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall
Overall PHN cases, Day 90
|
11.66 Percentage of PHN cases
Interval 8.46 to 15.54
|
|
Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall
Overall PHN cases, Day 180
|
42.86 Percentage of PHN cases
Interval 17.66 to 71.14
|
|
Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall
Overall PHN cases, Day 270
|
75.00 Percentage of PHN cases
Interval 19.41 to 99.37
|
SECONDARY outcome
Timeframe: Between Day 0 and Day 270.Population: The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
General medical history focused on characteristics such as patient pre-existing condition and diseases (local trauma, diabetes mellitus, liver disease, alcoholism, renal failure/dialysis, emotional problems, stress or depression, blood malignancy, solid malignancy, hematopoetic cell/ bone marrow transplant, solid organ transplantation, HIV infection, hepatitis C under active therapy, autoimmune disease active and under therapy, other).
Outcome measures
| Measure |
Herpes Zoster Group
n=391 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
General Medical History of Cases With HZ, Overall
Pre-existing condition, Yes
|
32.74 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Pre-existing condition, No
|
67.26 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Pre-existing condition, Missing Confirmed
|
0.00 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Local Trauma
|
3.91 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Diabetes mellitus
|
35.94 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Liver disease
|
4.69 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Alcoholism
|
2.34 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Renal failure/dialysis
|
7.03 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Emotional problems, stress or depression
|
32.03 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Blood malignancy
|
0.78 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Solid malignancy
|
3.91 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Hematopoetic cell/ bone marrow transplant
|
0.00 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Solid organ transplantation
|
0.78 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
HIV infection
|
0.78 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Hepatitis C under active therapy
|
0.78 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Autoimmune disease active and under therapy
|
5.47 Percentage of HZ cases
|
|
General Medical History of Cases With HZ, Overall
Other
|
25.00 Percentage of HZ cases
|
SECONDARY outcome
Timeframe: Between Day 0 and Day 270.Population: The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
Other general medical history characteristics referred to arterial problems, cerebral problems, gastric problems, gastric problems, prostate problems (arterial hypertension and allergic rhinitis, arterial hypertension and pacemaker, arteriopathy and past nun-Hodgkin lymphoma, atrial fibrillation, bronchopathy, cerebral thrombosis, cholecyst, chronic cerebral ischemia, chronic leukemia, chronic obstructive pulmonary disease, epilepsy, gastric lymphoma, gastropathy, hypertension, hypertension and hypothyroidism after surgery, hypertension dyslipidemia and hyperthyroidism, hypothyroidism hypertension, polycythaemia, polycythaemia from 10 years, prostate neoplasm, prostate oral anticoagulant therapy cardiopathy, prostatic cancer, right feet arthralgia, thrombocytopenia, vasculopathy chronic brain).
Outcome measures
| Measure |
Herpes Zoster Group
n=32 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Other General Medical History Characteristics for HZ Cases, Overall
Arterial hypertension and allergic rhinitis
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Arterial hypertension and pacemaker
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Arteriopathy and past non-Hodgkin lymphoma
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Atrial fibrillation
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Bronchopathy
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Cerebral thrombosis
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Cholecyst
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Chronic cerebral ischemia
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Chronic leukemia
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Chronic obstructive pulmonary disease
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Epilepsy
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Gastric lymphoma
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Gastropathy
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Hypertension
|
25.00 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Hypertension and hypothyroidism after surgery
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Hypertension dyslipidemia and hyperthyroidism
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Hypothyroidism hypertension
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Polycythaemia
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Polycythaemia from 10 years
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Prostate neoplasm
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Prostate oral anticoagulant therapy cardiopathy
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Prostatic cancer
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Right feet arthralgia
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Thrombocytopenia
|
3.13 Percentage of HZ cases
|
|
Other General Medical History Characteristics for HZ Cases, Overall
Vasculopathy chronic brain
|
3.13 Percentage of HZ cases
|
SECONDARY outcome
Timeframe: Between Day 0 and Day 270Population: The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
Clinical information of HZ cases referred to experience of any symptoms before rash, actual symptoms before rash (SBR), any complications at initial visit.
Outcome measures
| Measure |
Herpes Zoster Group
n=391 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Clinical Information of Cases With HZ, Overall
SBR, Fever
|
5.90 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
Any symptoms before rash, Yes
|
73.66 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
Any symptoms before rash, No
|
26.34 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Prodromal pain
|
82.64 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Malaise
|
29.17 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Ailment to the touch
|
0.35 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Burning sensation
|
3.13 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Dysesthesia
|
0.35 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Fever sensation
|
0.35 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Itching feeling of internal heat
|
0.35 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Itching
|
6.25 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Paresthesia
|
0.35 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Pain in right eyelid
|
0.35 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Pain in upper arms
|
0.35 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
SBR, Other:Sweating
|
0.00 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
Any complications at initial visit, Yes
|
16.62 Percentage of HZ cases
|
|
Clinical Information of Cases With HZ, Overall
Any complications at initial visit, No
|
83.38 Percentage of HZ cases
|
SECONDARY outcome
Timeframe: Between Day 0 and Day 270Population: The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
HZ related complications refer to cutaneous complications (Varicella Zoster Virus \[VZV\] dissemination, Bacterial superinfection), ocular (Loss of corneal sensation, Keratitis, Scleritis, Uveitis, Iridocyclitis), neurological (Meningo-encephalitis, Cranial nerve palsies, Peripheral nerve palsies, Ramsay-Hunt syndrome, Persistent HZ-related Pain), visceral \[Neural extension of VZV infection (bronchitis, esophagitis,cystitis), VZV dissemination (pneumonia, arthritis, hepatitis\] and other.
Outcome measures
| Measure |
Herpes Zoster Group
n=65 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Complications Related to HZ Cases, Overall
VZV dissemination
|
44.62 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Bacterial superinfection
|
7.69 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Loss of corneal sensation
|
0.00 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Keratitis
|
10.77 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Scleritis
|
0.00 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Uveitis
|
4.62 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Iridocyclitis
|
1.54 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Meningo-encephalitis
|
0.00 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Cranial nerve palsies
|
3.08 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Peripheral nerve palsies
|
0.00 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Ramsay-Hunt syndrome
|
0.00 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Persistent HZ-related Pain
|
64.62 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Neural extension of VZV infection
|
0.00 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Pneumonia, arthritis, hepatitis
|
1.54 Percentage of HZ complications
|
|
Complications Related to HZ Cases, Overall
Other
|
7.69 Percentage of HZ complications
|
SECONDARY outcome
Timeframe: Between Day 0 and Day 270Population: The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
HZ related other complications refer to axillary lympagenopathy, burning sensation, hypoacusis, itching and rectum pain.
Outcome measures
| Measure |
Herpes Zoster Group
n=5 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Other Complications Related to HZ Cases, Overall
Axillary lymphadenopathy
|
20.00 Percentage of HZ complications
|
|
Other Complications Related to HZ Cases, Overall
Burning sensation
|
20.00 Percentage of HZ complications
|
|
Other Complications Related to HZ Cases, Overall
Hypoacusis
|
20.00 Percentage of HZ complications
|
|
Other Complications Related to HZ Cases, Overall
Itching
|
20.00 Percentage of HZ complications
|
|
Other Complications Related to HZ Cases, Overall
Rectum pain
|
20.00 Percentage of HZ complications
|
SECONDARY outcome
Timeframe: Up to Day 90Population: The analysis was performed on the HZ subjects from the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
Cost data related to HZ included medication, procedures and referral to hospital/specialist for direct medical costs, transport for direct non-medical costs and missed time from work, sick certificate for the indirect costs.
Outcome measures
| Measure |
Herpes Zoster Group
n=391 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Direct Medical Costs, Direct Non-medical Costs and Indirect Costs
Direct Medical Cost
|
189 Euro
Standard Deviation 377
|
|
Direct Medical Costs, Direct Non-medical Costs and Indirect Costs
Productivity Loss - Subject
|
2124 Euro
Standard Deviation 1965
|
|
Direct Medical Costs, Direct Non-medical Costs and Indirect Costs
Productivity Loss - Caregiver
|
82 Euro
Standard Deviation 105
|
|
Direct Medical Costs, Direct Non-medical Costs and Indirect Costs
Transport
|
13 Euro
Standard Deviation 54
|
|
Direct Medical Costs, Direct Non-medical Costs and Indirect Costs
Overall
|
297 Euro
Standard Deviation 730
|
SECONDARY outcome
Timeframe: At Day 90Population: The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.
Outcome measures
| Measure |
Herpes Zoster Group
n=391 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Worst Pain Assessment in HZ Subjects
|
0.7 Scores on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: At Day 90Population: The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.
Outcome measures
| Measure |
Herpes Zoster Group
n=391 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Average Pain Assessment in HZ Subjects
|
0.5 Scores on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: At Day 0, 15, 30, 60, 90Population: The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
PHN persistence refers to pain occurring or persisting between 90-270 days after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.
Outcome measures
| Measure |
Herpes Zoster Group
n=391 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory
Day 0
|
3.478 Scores on a scale
Standard Deviation 2.707
|
|
Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory
Day 15
|
2.742 Scores on a scale
Standard Deviation 2.749
|
|
Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory
Day 30
|
1.823 Scores on a scale
Standard Deviation 2.459
|
|
Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory
Day 60
|
1.026 Scores on a scale
Standard Deviation 1.931
|
|
Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory
Day 90
|
0.578 Scores on a scale
Standard Deviation 1.471
|
SECONDARY outcome
Timeframe: At Day 0, 15, 30, 60, 90Population: The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
EuroQoL-Five Digits (EQ-5D) is a standardised instrument for use as a measure of health outcome and is designed for self-completion by respondents. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index/scale goes from 0 (worst health state) to 1 (perfect health state).
Outcome measures
| Measure |
Herpes Zoster Group
n=391 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 0
|
0.748 Scores on a scale
Standard Deviation 0.207
|
|
Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 15
|
0.801 Scores on a scale
Standard Deviation 0.198
|
|
Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 30
|
0.849 Scores on a scale
Standard Deviation 0.207
|
|
Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 60
|
0.901 Scores on a scale
Standard Deviation 0.175
|
|
Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 90
|
0.935 Scores on a scale
Standard Deviation 0.140
|
SECONDARY outcome
Timeframe: Between Day 90 and Day 270Population: The analysis was performed on the PHN subjects from the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
Cost data related to HZ included medication, procedures and referral to hospital/specialist for direct medical costs, transport for direct non-medical costs and missed time from work, sick certificate for the indirect costs.
Outcome measures
| Measure |
Herpes Zoster Group
n=40 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective
PHN, Payer
|
176 Euro
Standard Deviation 179
|
|
PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective
PHN, Societal
|
426 Euro
Standard Deviation 663
|
SECONDARY outcome
Timeframe: At Day 90Population: The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.
Outcome measures
| Measure |
Herpes Zoster Group
n=40 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Worst Pain Assessment in PHN Subjects
|
5.7 Scores on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: At Day 90Population: The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. The ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.
Outcome measures
| Measure |
Herpes Zoster Group
n=40 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Average Pain Assessment in PHN Subjects
|
4.2 Scores on a scale
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: At Day 0, 15, 30, 60, 90Population: The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol).
PHN persistence refers to pain occurring or persisting between 90-270 days after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.
Outcome measures
| Measure |
Herpes Zoster Group
n=40 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory
Day 0
|
5.967 Scores on a scale
Standard Deviation 2.550
|
|
Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory
Day15
|
6.062 Scores on a scale
Standard Deviation 2.385
|
|
Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory
Day 30
|
5.553 Scores on a scale
Standard Deviation 2.600
|
|
Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory
Day 60
|
4.315 Scores on a scale
Standard Deviation 2.550
|
|
Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory
Day 90
|
3.671 Scores on a scale
Standard Deviation 2.145
|
SECONDARY outcome
Timeframe: At Day 0, 15, 30, 60, 90Population: The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who mett all eligibility criteria and complied with the study procedures defined in the protocol).
EuroQoL-Five Digits (EQ-5D) is a standardised instrument for use as a measure of health outcome and is designed for self-completion by respondents. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was 0 (worst health state) to 1 (best health state).
Outcome measures
| Measure |
Herpes Zoster Group
n=40 Participants
Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.
|
|---|---|
|
Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 0
|
0.592 Scores on a scale
Standard Deviation 0.227
|
|
Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 15
|
0.582 Scores on a scale
Standard Deviation 0.284
|
|
Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 30
|
0.542 Scores on a scale
Standard Deviation 0.317
|
|
Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 60
|
0.688 Scores on a scale
Standard Deviation 0.275
|
|
Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits
Day 90
|
0.732 Scores on a scale
Standard Deviation 0.202
|
Adverse Events
Herpes Zoster Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER