Eur J Dermatol 2015; 25(1): 64-69
Clinical report Andrea CHIRICOZZI Luca BIANCHI Arianna ZANGRILLI Mauro BAVETTA Alessandro GIUNTA Sergio CHIMENTI Rosita SARACENO Department of Dermatology, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy
Reprints: A. Chiricozzi
Article accepted on 10/21/2014
P
Quality of life of psoriatic patients evaluated by a new psychometric assessment tool: PsoDisk Background: Psoriasis is a chronic skin disorder which negatively impacts a patient’s quality of life (QoL). A recently published assessment tool, PsoDisk, has been proposed to evaluate patient’s QoL. Objective: The aim of this study was to test PsoDisk as a QoL assessment tool in psoriatic patients undergoing treatment with adalimumab. Methods: A retrospective, monocentric study, including patients who completed at least 48 weeks of both adalimumab therapy and PsoDisk assessment. PASI was assessed by the physician whereas the PsoDisk test was self-performed by the patient. Both were evaluated at each control visit throughout the study-period in order to detect changes in disease severity and the impact of quality of life, respectively. Results: In total, we evaluated 31 patients selected from our database. At baseline, all aspects of patients’ psycho-emotional and social lives were impaired. PASI score reduction correlated with a PsoDisk score decrease (r = 0.97; p = 0.02), reflecting an overall improvement of patient’s QoL. Conclusion: PsoDisk was found to be easy to administer and intuitive for interpreting clinical results. Key words: psoriasis, quality of life, biologicals, adalimumab, Psodisk
64
proposed [21]. It is designed to make it easy for both the patient and the physician to define and read the patient’s overall feelings. Its ease of use and its intuitiveness derive from a striking graphic representation. This study evaluated: 1) the impact of psoriasis on QoL assessed by PsoDisk in a group of patients undergoing treatment with adalimumab; 2) the correlation between clinical response and PsoDisk changes.
Materials and methods Study population A retrospective study of the clinic database at the Department of Dermatology, University of Rome Tor Vergata was performed, using the term “adalimumab”. The study was approved by the local ethical committee. From the whole generated database list, we selected consecutive subjects from the period starting from October 2012 until January 2013, who both reached 48 week-treatment with adalimumab and performed PsoDisk test at every follow-up visit. We reviewed the patients’ clinical and personal histories: age, sex, educational level, job, psoriasis phenotype, onset of disease, comorbidities, previous topical and systemic antipsoriatic therapy and any concurrent medication. All patients treated with adalimumab were unresponsive or contraindicated to at least two systemic conventional therapies. Patients with active or treated (in the previous five years) neoplastic disease, severe heart failure, demyelinating disorders or HIV infection were excluded. EJD, vol. 25, n◦ 1, January-February 2015
To cite this article: Chiricozzi A, Bianchi L, Zangrilli A, Bavetta M, Giunta A, Chimenti S, Saraceno R. Quality of life of psoriatic patients evaluated by a new psychometric assessment tool: PsoDisk. Eur J Dermatol 2015; 25(1): 64-69 doi:10.1684/ejd.2014.2473
doi:10.1684/ejd.2014.2473
soriasis is a common, disabling skin disorder affecting 2-3% of the Italian population [1]. Mildto-moderate psoriasis, which represents 70-80% of cases, is usually treated with topical agents and/or phototherapy, whereas for moderate-to-severe psoriasis a systemic treatment is usually prescribed, including traditional therapeutics (cyclosporine, methotrexate, acitretin), phototherapy (PUVA, RE-PUVA) and biologic agents. Anti-TNF␣ agents, namely etanercept, adalimumab, infliximab and golimumab, are the most common biologics used for the treatment of plaque-type psoriasis and/or psoriatic arthritis [2, 3]. Psoriasis may have a negative impact on a patient’s quality of life (QoL), impairing physical, social, sexual and emotional spheres [4-8]. A high-grade severity of disease usually correlates with a relevant psycho-social impact but even mild psoriasis localized in “sensitive” areas (face, hands, genital areas, scalp) may negatively affect QoL. This psychological impact may be so burdensome as to reduce work activity and productivity, to impair social relationships, and, in the worst cases, leading to suicidal ideation [9-18]. In clinical practice, this aspect is not adequately considered because it implies that extra time is needed for each visit and dermatologists may be not skilled in addressing and managing the psychological aspects of disease. Various clinical tools, including dermatology life quality index (DLQI) and 36-Item Short Form Health Survey (SF36), are widely used and represent a relevant parameter to define severe psoriasis [19, 20]. However, they may be difficult for patients to understand and cumbersome for health care operators to analyze. Recently, a novel instrument, PsoDisk, evaluating the QoL of psoriatic patients, has been
Table 1. Demographic features of the study population. Absolute count (n) and percentage (%) were reported for all variables. Mean age and standard deviation (SD) were calculated. Variable
n (%)
Total patient number
31
Male
18/31 (58.1)
Female
13/31 (41.9)
Mean age (years)
52.16 (SD = ± 14.16)
Psoriasis vulgaris
12/31 (38.7)
Psoriasis arthritis
19/31 (61.3)
Previously treated with biologic agents
15/31 (48.4)
Patients naive to any previous biologic therapy College school
16/31 (51.6) 14/31 (45.2)
Graduate school Employed
17/31 (54.8) 26/31 (83.9)
Retired
5/31 (16.1)
Educational level
Work activity
According to the approved therapeutic scheme, patients affected by plaque-type psoriasis were treated with 80 mg adalimumab at week 0, followed by 40 mg adalimumab at Week 1 and every two weeks, while patients with psoriatic arthritis received 40 mg adalimumab every other week from Week 0. Clinical response was evaluated by PASI score and QoL was assessed by PsoDisk. Joint involvement was assessed by Pain-Visual Analog Scale (VAS) included in the PsoDisk questionnaire, termed as “pain”.
PASI PASI is a quantitative rating score for assessing the severity of disease, widely used in both trials and clinical practice [22]. We calculated the PASI score at the Baseline and at weeks 4, 12, 24, and 48.
Pso Disk PsoDisk is a recently proposed questionnaire evaluating a patient’s QoL [21]. The patient is required to answer the questions on a numbered visual analogue scale. The answers were then marked on a coloured disc, finally allowing the drawing of a polygon. Whenever the burden of the disease on the patient decreases, the area of the polygon shrinks, thus providing both the physician and the patient with an immediate and intuitive representation of the progress achieved. It was administered at the Baseline and at weeks 4, 12, 24, and 48. The PsoDisk questionnaire consists of 10 items addressing various aspects of a patient’s life namely: overall health, pain, itch, sleep, social life, work and other daily activities, peace of mind, sexual life, shame, skin involvement. Each item was briefly described by a short sentence. Although PsoDisk is designed to be filled out jointly by the dermatologist and the patient, all subjects self-completed the questionnaires. Answers ranges from “absolutely no” EJD, vol. 25, n◦ 1, January-February 2015
(scored as 0) to “definitely yes” (scored as 10), referring to the previous week as time frame. Because of the facilitated colored graphics, drawing a line joining each score (which reflects the patient’s answers), a polygon is obtained: a large polygon area suggests a low QoL, whereas a small polygon area suggests a high QoL.
Statistical analysis Patients’ characteristics were reported as mean and standard deviation (SD) for continuous variables, frequencies and percentages, for each category. Time-point comparisons were carried out using paired t-test, whereas the statistical significance of inter-group comparisons was evaluated by unpaired t-test. P-values lower than 0.05 were considered statistically significant. The assumption of normal distribution was checked using the Kolmogorov Smirnov and Shapiro Wilks as well as by graphical inspection. Pearson’s correlation coefficient was calculated in order to test the correlation between PASI score and PsoDisk score.
Results Adalimumab therapy showed high efficacy throughout 48 weeks of treatment From the database revision we obtained thirty-one patients who were continuously treated for at least 48 weeks with adalimumab and, concomitantly, were tested with PsoDisk throughout the 48-week study period. Of thirty-one patients, 18 were male and 13 were female (table 1). The mean age was 50 years (SD: ± 14.27), with a range from 25 to 74 years. Twelve of thirty-one patients (38.7%) and 19/31 (61.3%) subjects had plaque-type psoriasis and psoriatic arthritis, respectively. All patients
65
70 60
60 50
38
40 30
23
22
20
15
7.9
10
3
1
1
1.1
T12
T24
T48
0 Baseline
T4
Mean PSODISK score Mean PASI score
Figure 1. Amelioration of PASI score correlated with improvement of PsoDisk score: Variation of quality of life and disease severity during 48-week adalimumab therapy, measured by PsoDisk assessment and PASI evaluation, respectively. The reduction of PASI score was associated with a decrease in PsoDisk values. Both scores decreased with a correlation coefficient of 0.97 (p = 0.02).
suffering from moderate-to-severe psoriasis (mean PASI score at the Baseline: 7.9) were contraindicated and/or nonresponders to traditional systemic therapeutics and they were successfully screened for starting a biologic therapy. Among them, 15 patients had been previously treated with at least one biologic agent (table 1). A rapid response to adalimumab therapy was observed, with a reduced mean PASI score of 3 after 4 weeks and, at Week 48, mean PASI score declined to 1.01 (figure 1).
PsoDisk showed poor QoL in psoriatic patients The PsoDisk test at the Baseline showed high scores for all items proposed, reflecting a negative impact on QoL. The overall mean PsoDisk score was 60.00: specifically the most affected aspect was the item “skin involvement” (mean score: 7.13; SD: ± 3.35), whereas the least impaired was “sleep” (mean score: 4.10; SD: ± 3.40) (table 2). Notably, sexual life, work (at the office or at home), and other daily activities (studying, running households, cultivating hobbies, sports, etc), were strongly impacted by
psoriasis (mean score: 6.74; SD: ± 2.85). The impact of psoriasis on these activities referred to a real functional limitation due to the disease, while reticence and shame of being socially active (participating in events, practising sports, going to the beach or swimming pool) were addressed by the headings “shame” (mean score: 6.58; SD: ± 3.61) and “social life” (mean score: 5.82; SD: ± 3.27). “Health” and “peace of mind” were overall impaired with a score of 5.48 and 6.10, respectively. Moreover, 60% of patients scored psoriasis-associated pruritus as ≥ 5, with a mean value of 5.97 (SD: ± 3.35) (table 2). Subgroup analyses showed that PsoDisk outcomes were not affected by any variant, including age, sex, joint involvement and educational level. The latter did not influence the use of the questionnaire which was easily filled out without the physician’s help. Nevertheless, we observed a different perception of disease with a poorer QoL in females, in subjects suffering from psoriatic arthritis or in over 50-year-old subjects compared to males who suffered from plaquetype psoriasis or under-50 patients, respectively. However, these differences were not statistically significant (data not shown).
Table 2. PsoDisk assessment of patients’ quality of life during adalimumab therapy. PsoDisk scores and comparison at each time-point: Baseline, Week 4, Week 12, Week 24, and Week 48.
Overall health Pain Itch Sleep Peace of mind Social life Work Sexual life Shame Skin involvement
66
Baseline
Week 4
p value week4/baseline
Week 12
p value week12/baseline
Week 24
p value week24/baseline
Week 48
p value week48/baseline
5.48 6.00 5.97 4.10 6.10 5.82 6.74 5.68 6.58 7.13
4.16 3.77 3.90 2.68 3.74 3.55 4.06 3.90 3.94 4.45
0.036
Clinical report Andrea CHIRICOZZI Luca BIANCHI Arianna ZANGRILLI Mauro BAVETTA Alessandro GIUNTA Sergio CHIMENTI Rosita SARACENO Department of Dermatology, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy
Reprints: A. Chiricozzi
Article accepted on 10/21/2014
P
Quality of life of psoriatic patients evaluated by a new psychometric assessment tool: PsoDisk Background: Psoriasis is a chronic skin disorder which negatively impacts a patient’s quality of life (QoL). A recently published assessment tool, PsoDisk, has been proposed to evaluate patient’s QoL. Objective: The aim of this study was to test PsoDisk as a QoL assessment tool in psoriatic patients undergoing treatment with adalimumab. Methods: A retrospective, monocentric study, including patients who completed at least 48 weeks of both adalimumab therapy and PsoDisk assessment. PASI was assessed by the physician whereas the PsoDisk test was self-performed by the patient. Both were evaluated at each control visit throughout the study-period in order to detect changes in disease severity and the impact of quality of life, respectively. Results: In total, we evaluated 31 patients selected from our database. At baseline, all aspects of patients’ psycho-emotional and social lives were impaired. PASI score reduction correlated with a PsoDisk score decrease (r = 0.97; p = 0.02), reflecting an overall improvement of patient’s QoL. Conclusion: PsoDisk was found to be easy to administer and intuitive for interpreting clinical results. Key words: psoriasis, quality of life, biologicals, adalimumab, Psodisk
64
proposed [21]. It is designed to make it easy for both the patient and the physician to define and read the patient’s overall feelings. Its ease of use and its intuitiveness derive from a striking graphic representation. This study evaluated: 1) the impact of psoriasis on QoL assessed by PsoDisk in a group of patients undergoing treatment with adalimumab; 2) the correlation between clinical response and PsoDisk changes.
Materials and methods Study population A retrospective study of the clinic database at the Department of Dermatology, University of Rome Tor Vergata was performed, using the term “adalimumab”. The study was approved by the local ethical committee. From the whole generated database list, we selected consecutive subjects from the period starting from October 2012 until January 2013, who both reached 48 week-treatment with adalimumab and performed PsoDisk test at every follow-up visit. We reviewed the patients’ clinical and personal histories: age, sex, educational level, job, psoriasis phenotype, onset of disease, comorbidities, previous topical and systemic antipsoriatic therapy and any concurrent medication. All patients treated with adalimumab were unresponsive or contraindicated to at least two systemic conventional therapies. Patients with active or treated (in the previous five years) neoplastic disease, severe heart failure, demyelinating disorders or HIV infection were excluded. EJD, vol. 25, n◦ 1, January-February 2015
To cite this article: Chiricozzi A, Bianchi L, Zangrilli A, Bavetta M, Giunta A, Chimenti S, Saraceno R. Quality of life of psoriatic patients evaluated by a new psychometric assessment tool: PsoDisk. Eur J Dermatol 2015; 25(1): 64-69 doi:10.1684/ejd.2014.2473
doi:10.1684/ejd.2014.2473
soriasis is a common, disabling skin disorder affecting 2-3% of the Italian population [1]. Mildto-moderate psoriasis, which represents 70-80% of cases, is usually treated with topical agents and/or phototherapy, whereas for moderate-to-severe psoriasis a systemic treatment is usually prescribed, including traditional therapeutics (cyclosporine, methotrexate, acitretin), phototherapy (PUVA, RE-PUVA) and biologic agents. Anti-TNF␣ agents, namely etanercept, adalimumab, infliximab and golimumab, are the most common biologics used for the treatment of plaque-type psoriasis and/or psoriatic arthritis [2, 3]. Psoriasis may have a negative impact on a patient’s quality of life (QoL), impairing physical, social, sexual and emotional spheres [4-8]. A high-grade severity of disease usually correlates with a relevant psycho-social impact but even mild psoriasis localized in “sensitive” areas (face, hands, genital areas, scalp) may negatively affect QoL. This psychological impact may be so burdensome as to reduce work activity and productivity, to impair social relationships, and, in the worst cases, leading to suicidal ideation [9-18]. In clinical practice, this aspect is not adequately considered because it implies that extra time is needed for each visit and dermatologists may be not skilled in addressing and managing the psychological aspects of disease. Various clinical tools, including dermatology life quality index (DLQI) and 36-Item Short Form Health Survey (SF36), are widely used and represent a relevant parameter to define severe psoriasis [19, 20]. However, they may be difficult for patients to understand and cumbersome for health care operators to analyze. Recently, a novel instrument, PsoDisk, evaluating the QoL of psoriatic patients, has been
Table 1. Demographic features of the study population. Absolute count (n) and percentage (%) were reported for all variables. Mean age and standard deviation (SD) were calculated. Variable
n (%)
Total patient number
31
Male
18/31 (58.1)
Female
13/31 (41.9)
Mean age (years)
52.16 (SD = ± 14.16)
Psoriasis vulgaris
12/31 (38.7)
Psoriasis arthritis
19/31 (61.3)
Previously treated with biologic agents
15/31 (48.4)
Patients naive to any previous biologic therapy College school
16/31 (51.6) 14/31 (45.2)
Graduate school Employed
17/31 (54.8) 26/31 (83.9)
Retired
5/31 (16.1)
Educational level
Work activity
According to the approved therapeutic scheme, patients affected by plaque-type psoriasis were treated with 80 mg adalimumab at week 0, followed by 40 mg adalimumab at Week 1 and every two weeks, while patients with psoriatic arthritis received 40 mg adalimumab every other week from Week 0. Clinical response was evaluated by PASI score and QoL was assessed by PsoDisk. Joint involvement was assessed by Pain-Visual Analog Scale (VAS) included in the PsoDisk questionnaire, termed as “pain”.
PASI PASI is a quantitative rating score for assessing the severity of disease, widely used in both trials and clinical practice [22]. We calculated the PASI score at the Baseline and at weeks 4, 12, 24, and 48.
Pso Disk PsoDisk is a recently proposed questionnaire evaluating a patient’s QoL [21]. The patient is required to answer the questions on a numbered visual analogue scale. The answers were then marked on a coloured disc, finally allowing the drawing of a polygon. Whenever the burden of the disease on the patient decreases, the area of the polygon shrinks, thus providing both the physician and the patient with an immediate and intuitive representation of the progress achieved. It was administered at the Baseline and at weeks 4, 12, 24, and 48. The PsoDisk questionnaire consists of 10 items addressing various aspects of a patient’s life namely: overall health, pain, itch, sleep, social life, work and other daily activities, peace of mind, sexual life, shame, skin involvement. Each item was briefly described by a short sentence. Although PsoDisk is designed to be filled out jointly by the dermatologist and the patient, all subjects self-completed the questionnaires. Answers ranges from “absolutely no” EJD, vol. 25, n◦ 1, January-February 2015
(scored as 0) to “definitely yes” (scored as 10), referring to the previous week as time frame. Because of the facilitated colored graphics, drawing a line joining each score (which reflects the patient’s answers), a polygon is obtained: a large polygon area suggests a low QoL, whereas a small polygon area suggests a high QoL.
Statistical analysis Patients’ characteristics were reported as mean and standard deviation (SD) for continuous variables, frequencies and percentages, for each category. Time-point comparisons were carried out using paired t-test, whereas the statistical significance of inter-group comparisons was evaluated by unpaired t-test. P-values lower than 0.05 were considered statistically significant. The assumption of normal distribution was checked using the Kolmogorov Smirnov and Shapiro Wilks as well as by graphical inspection. Pearson’s correlation coefficient was calculated in order to test the correlation between PASI score and PsoDisk score.
Results Adalimumab therapy showed high efficacy throughout 48 weeks of treatment From the database revision we obtained thirty-one patients who were continuously treated for at least 48 weeks with adalimumab and, concomitantly, were tested with PsoDisk throughout the 48-week study period. Of thirty-one patients, 18 were male and 13 were female (table 1). The mean age was 50 years (SD: ± 14.27), with a range from 25 to 74 years. Twelve of thirty-one patients (38.7%) and 19/31 (61.3%) subjects had plaque-type psoriasis and psoriatic arthritis, respectively. All patients
65
70 60
60 50
38
40 30
23
22
20
15
7.9
10
3
1
1
1.1
T12
T24
T48
0 Baseline
T4
Mean PSODISK score Mean PASI score
Figure 1. Amelioration of PASI score correlated with improvement of PsoDisk score: Variation of quality of life and disease severity during 48-week adalimumab therapy, measured by PsoDisk assessment and PASI evaluation, respectively. The reduction of PASI score was associated with a decrease in PsoDisk values. Both scores decreased with a correlation coefficient of 0.97 (p = 0.02).
suffering from moderate-to-severe psoriasis (mean PASI score at the Baseline: 7.9) were contraindicated and/or nonresponders to traditional systemic therapeutics and they were successfully screened for starting a biologic therapy. Among them, 15 patients had been previously treated with at least one biologic agent (table 1). A rapid response to adalimumab therapy was observed, with a reduced mean PASI score of 3 after 4 weeks and, at Week 48, mean PASI score declined to 1.01 (figure 1).
PsoDisk showed poor QoL in psoriatic patients The PsoDisk test at the Baseline showed high scores for all items proposed, reflecting a negative impact on QoL. The overall mean PsoDisk score was 60.00: specifically the most affected aspect was the item “skin involvement” (mean score: 7.13; SD: ± 3.35), whereas the least impaired was “sleep” (mean score: 4.10; SD: ± 3.40) (table 2). Notably, sexual life, work (at the office or at home), and other daily activities (studying, running households, cultivating hobbies, sports, etc), were strongly impacted by
psoriasis (mean score: 6.74; SD: ± 2.85). The impact of psoriasis on these activities referred to a real functional limitation due to the disease, while reticence and shame of being socially active (participating in events, practising sports, going to the beach or swimming pool) were addressed by the headings “shame” (mean score: 6.58; SD: ± 3.61) and “social life” (mean score: 5.82; SD: ± 3.27). “Health” and “peace of mind” were overall impaired with a score of 5.48 and 6.10, respectively. Moreover, 60% of patients scored psoriasis-associated pruritus as ≥ 5, with a mean value of 5.97 (SD: ± 3.35) (table 2). Subgroup analyses showed that PsoDisk outcomes were not affected by any variant, including age, sex, joint involvement and educational level. The latter did not influence the use of the questionnaire which was easily filled out without the physician’s help. Nevertheless, we observed a different perception of disease with a poorer QoL in females, in subjects suffering from psoriatic arthritis or in over 50-year-old subjects compared to males who suffered from plaquetype psoriasis or under-50 patients, respectively. However, these differences were not statistically significant (data not shown).
Table 2. PsoDisk assessment of patients’ quality of life during adalimumab therapy. PsoDisk scores and comparison at each time-point: Baseline, Week 4, Week 12, Week 24, and Week 48.
Overall health Pain Itch Sleep Peace of mind Social life Work Sexual life Shame Skin involvement
66
Baseline
Week 4
p value week4/baseline
Week 12
p value week12/baseline
Week 24
p value week24/baseline
Week 48
p value week48/baseline
5.48 6.00 5.97 4.10 6.10 5.82 6.74 5.68 6.58 7.13
4.16 3.77 3.90 2.68 3.74 3.55 4.06 3.90 3.94 4.45
0.036
