Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort

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1 26 Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort Majed Khraishi 1 2, Jennifer Hulburt, Sarah Khraishi and Courtney Youden 2 1 Memorial University of Newfoundland, St. John s, Newfoundland, Canada 2 Nexus Clinical Research, St. John s, Newfoundland, Canada Corresponding author: Address for correspondence Dr. Majed Khraishi 120 Stavanger Drive Suite 102 St. John s, NL, Canada A1A 5E8 Fax: mkhraishi@nexusresearch.com ABSTRACT Psoriatic arthritis (PSA) is a serious disease affecting 10-35% of patients with psoriasis (PSO). The combination of joint and skin manifestations of PSA can have a profound impact on patient function and quality of life (QoL). Skin manifestations of the disease have an impact on work and social interactions, while joint damage in PSA also has a negative effect on function and QoL. The SF36 (Short Form with 36 questions) and the Dermatology Life Quality Index (DLQI) are well-documented, self-administered QoL scoring assessments which have been widely used. However the impact of the skin disease in PSA and the joint disease in PSO is rarely taken into consideration when assessing QoL in these patients, particularly in early stages of PSA. In the following we attempt to illustrate the impact of early stage PSA on QoL through assessment of patients response to the DLQI and SF-36 questionnaires. INTRODUCTION Psoriatic arthritis (PSA) is a serious inflammatory disease affecting 10-35% of patients with psoriasis (PSO). In approximately 80% of patients with PSA, the skin disease manifests itself before arthritis, typically 8-10 years before the arthritis symptoms [1]. The combination of joint and skin manifestations of PSA can have a profound impact on a patient s function and quality of life (QoL). Patients with PSO are concerned with visible manifestations of the condition and how it is perceived by others, often resulting in a negative body image, and feeling embarrassed and self conscious [2]. Many feel stigmatized because of their condition [3], and skin manifestations of the disease have a significant impact on work and social interactions [2]. At the same time, joint damage in PSA also has a negative affect on function and QoL [4]. Patients with PSA have significantly more limitations in dressing, walking, and overall activities of daily living limitations compared to those without PSA [5]. Even though joint damage has been reported to be less severe in PSA than in rheumatoid arthritis, PSA has a similar impact on function and QoL [6]. In addition, people with PSA report more bodily pain and role limitations from emotional problems than those with other

2 Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort 27 types of arthritis [7]. These findings suggest that the dual manifestation of skin and joint disease characteristics may have profound implications among this group. Despite this, many treatments for PSA focus on physical disease measures as the primary determinant of efficacy. Therefore, factors influencing choice of treatment for PSA should include QoL, and a standard QoL assessment tool could be included to define disease severity. Assessing QoL can complement clinical assessments of disease characteristics by providing a multidimensional appraisal of the patient s overall well-being. A variety of instruments have been proposed for evaluation of QoL in patients with PSA. While some are widely used across many diseases (i.e. the SF 36 Health Survey (Short Form with 36 questions), the EuroQol, the Health Assessment Questionnaire), others are more specific to dermatologic conditions (i.e. the Dermatology Life Quality Index). It has been recommended that the combination of a generic and a dermatology-specific quality of life instrument may provide the most comprehensive assessment in patients suffering from skin and joint disease manifestation [8]. The SF 36 has been validated in PSA studies, assessing QoL in several clinical trials [9, 10]. The DLQI is the most commonly used instrument in psoriasis, and has been used in several studies on PSA [11-15]. However, there are only a few studies on PSA using the SF 36 and DLQI in combination to assess QoL in PSA (Gladman, Mease et al. 2007; Feldman, Gottlieb et al. 2008). The HAQ has been widely used in clinical trials to capture functional impairment associated with joint damage in PSA. However, it has not been shown to correlate well with all measures of disease severity and disease activity [16]. The SF36 Health Assessment Questionnaires (HAQ) and the Dermatology Life Quality Index (DLQI) are well-documented, self-administered, QoL scoring assessments which have been widely used. However the impact of the skin disease in PSA and the joint disease in PSO is rarely taken into consideration when assessing QoL in these patients, particularly in early stages of PSA. In the following we attempt to illustrate the impact of early stages PSA on QoL by examining the associations between QoL and skin and joint disease characteristics in a cohort of early PSA patients. METHODS Patients This study presents results from a subset of 48 patients from a prospective study on PSA patients in Newfoundland, Canada from January 2008 to December The patients were referred by dermatologists or general practitioners to a rheumatology clinic specializing in PSA for assessment of possible arthritis. Epidemiologic, clinical and serological data were collected at base line and at six month intervals.the diagnosis of PSA was made according to the CASPAR criteria [17]. Inclusion criteria Patients who were 19 years of age or older, and had a medical diagnosis of psoriasis within the last 10 years were included in this study. They also had less than two years of arthritic

3 Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort 28 symptoms duration [17]. Patients were not included if any of the following criteria were met: subject had an active skin disease other than psoriasis that would interfere with the assessment of the PASI, subject has a history of, or current inflammatory joint disease other than PSA, (e.g. mixed connective tissue disease, systemic lupus erythematosus etc.), or subject has a history of clinically significant drug or alcohol abuse in the last year [17]. All eligible patients who gave their written informed consent were recruited into the study. Clinical Assessment After medical history was obtained, detailed examinations were performed by the rheumatologist (e.g. tender and/or swollen joints), involvement of axial joints (e.g. spine and SI joints). An experienced nurse in psoriasis research and the rheumatologist assessed separately the nail involvement and the degree of psoriasis involvement. This was measured as a percentage of the total body surface area involved (BSA). Specifically, four body regions (i.e. head, upper extremities, trunk, lower extremities) involvement was calculated in addition to the severity of psoriasis, expressed as. Quality of Life The HAQ, DLQI, and SF 36 were administered during the baseline visit, and then every 6 months. We included in this study the first assessments completed ( at the screen/baseline visit). The HAQ assesses the physical function and health-related quality of life of each subject, with the following eight scales: dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. Patients were asked to rate the level of difficulty of the individual items over the past week on a 4-point scale (0= no difficulty performing, 3= unable to do). Scoring instructions for the physical disability scales are provided by the HAQ authors [18]. Responses are calculated to provide a score in a range of 0-3, with higher scores reflecting greater disability and pain. The SF-36 is an established QoL tool that was designed to be applicable to a wide range of types and severity of conditions. It assesses the functional status, well-being, and general perceptions of health. It includes 36 items in a Likert-type format to measure the following eight dimensions: physical functioning (PF, limitations in physical activities because of health problems, role-physical (RP, limitations in daily activities as a result of physical health), bodily pain (BP, limitations and severity of pain), general health (GH, self-evaluation of general personal health), vitality (VT, feeling tired and worn out vs. feeling full of energy), social functioning (SF, interference with normal social activities due to physical or emotional problems), role-emotional (RE, limitations with daily activities as a result of emotional problems), and mental health (MH, feeling nervous and depressed vs. peaceful, happy, and calm). Patients were asked to rate level of functioning and well-being over the past week. In addition there is a single item directed at possible changes in respondents health over the past year. Subscale scores from each domain are calculated by summing the individual items and transforming the scores from each domain to a 0 to 100 range, with high scores indicating a better status. A physical health and mental health summary score was computed for this study. The DLQI is a dermatology-specific instrument consisting of ten items which measures symptoms, feelings, daily activities, leisure, work and school, personal relationships, and treatment domains [19]. Patients were asked to rate the level of impairment they

4 Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort 29 experienced (i.e. Very much to Not at all ) in each of the six domains. Total scores are computed to range from 0 and 30, with higher scores indicating poorer QoL. DLQI score of 0 1 means no effect on QoL ; 2 5, small effect ; 6 10, moderate effect ; 11 20, very large effect ; and 21 30, extremely large effect. ANALYSIS Continuous variables were reported as means standard deviation (SD). Pearson s correlation coefficient was used to assess associations between clinical disease characteristics and quality of life measures (i.e. SF 36, HAQ, and DLQI). Before performing the regression analysis, those variables with asymmetric distribution (i.e. severity of psoriasis (BSA), duration of PSA symptoms, skin involvement (head, upper extremity, trunk, lower extremity), HAQ scores, SF-36 scores, joint distribution, and DLQI scores) were transformed with natural logarithm and square root logarithm transformations. A set of multivariable analyses were constructed to adjust for factors potentially associated with QoL scores. Covariates chosen a priori included disease duration (years from disease onset as a continuous variable) and severity of psoriasis (body surface area percentage as a continuous variable). These factors were then introduced as covariates in multiple regression models in which the DLQI, HAQ, and SF 36 were dependent variables. All variables were entered simultaneously. A p value < 0.05 was considered statistically significant. Data were analyzed with SPSS, release RESULTS The demographic, clinical, and laboratory characteristics of the patients are summarized in Table 1. Forty eight patients who met the CASPAR criteria were included at the time of this analysis, 61 % of them were females with a mean age of 48 years Average PSA symptoms duration was 12.6 months 9.3. the mean age of diagnosis of psoriasis was 41.3 (SD 13,8 years). Thus the mean duration of psoriasis symptoms before the onset of PSA was about 7 years in this cohort. At clinical examination, polyarthritis was the most frequent disease subset, occurring in 66% of patients while spondylitis was less common, occurring in 28% of patients. Results of the QoL scores (mean SD) were DLQI , SF-36 mental domain , SF-36 physical domain , and HAQ On the DLQI questionnaire, 71% of early PSA patients reported psoriasis to have either no effect or a small effect on their QoL. The correlations among the QoL scores and disease measures are presented in Table 2. As predicted, positive correlations were found between the DLQI and psoriasis severity as manifested by BSA (r=.62, p <.01), duration of skin disease symptoms (r=.33, p <.05), and percentage of skin involvement on the head (r=.57, p<.01), trunk (r=.70, p <.05), and lower extremity (r=.71, p <.01). No significant correlation was found between DLQI scores and skin involvement of the upper extremity. DLQI scores were inversely related to patient age (r= -.29, p <.05). Multiple linear regression analysis was used to develop a model for predicting QoL scores from disease characteristics. The results of multiple variable regression analyses are summarized in Table 3. Covariates chosen a priori included disease-related characteristics

5 Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort 30 (BSA, skin involvement, disease duration, and joint distribution). All these factors were introduced as covariates in multiple regression models in which SF-36 physical and mental domain summary scores, DLQI scores, and HAQ scores were dependent variables. BSA was the most important predictor for QoL scores as measured by the DLQI. BSA and SF 36 mental domain scores were better predictors of DLQI scores than a combination of the BSA and SF 36 physical domain scores. After controlling for polyarthritis, BSA and disease duration still accounted for 70% of the variance in DLQI scores. BSA and disease duration did not predict scores on the SF 36 or HAQ questionnaires. The three predictor model (mental domain SF 36 scores, BSA, and disease duration) accounted for 70% of the variance in DLQI scores (adjusted R 2 = 0.441). In summary, the BSA was the most important predictor for DLQI scores. DISCUSSION Measurement of PSA and PSO impact on the patients often involves assessment of both the physical characteristics as well as its effect on patient driven outcomes such as QoL scores and the subjective experience of the patient. Although the impact of the skin disease is often measured by changes in the skin psoriasis severity utilizing the PASI score and other clinical measurements, they do not always provide a complete picture of the patient s health status. Measuring QoL provides a complementary assessment of the patient s overall well-being because it describes the patient s perception of the disease, encompassing physical and psychosocial factors related to the disease. Some authors examined the clinical presentation and radiological outcomes of early psoriatic arthritis patients [20, 21]. While Kane et al. (2003) included a QoL measure (HAQ), the main objective of the study was to determine the clinical presentation and outcomes of early psoriatic arthritis. In reality PSA studies in general often overlook the specific impact of the skin disease on the PSA patients. To our knowledge, no studies have assessed the relations between QoL scores with disease characteristics in a cohort of early psoriatic arthritis patients. In our study, we found that higher percentages of skin involvement, longer disease duration, and more severe psoriasis as manifested by BSA were associated with poorer QoL scores on the DLQI. Patient age was negatively associated with the DLQI scores. This study confirms that PSA, even at an earlier stage, can result in significant impairments of patients perception of QoL. The DLQI [22], HAQ [23], and SF-36 [24] have been validated for the assessment of function in PSA. In this study, BSA, disease duration, and SF-36 scores predicted DLQI scores at an early stage in PSA. Nearly 30% of our patients reported some impact of their skin disease on their quality of life though the mean DLQI scores were lower in this study than other recent studies have reported. [12] Feldman for example studied PSA patients with an average disease duration of years (as compared to one year in our cohort). Measuring QoL in patients with longer disease duration may result in lower ratings of QoL. However, the results of our study indicate that even in early stages, skin involvement in PSA may affect quality of life. As rheumatologists often concentrate on the joint disease in PSA, understanding the impact of psoriasis in these patients may influence their choice of optimal therapy to assure that both components, skin and joints, are targeted. Measuring QoL in PSA requires multiple instruments because of the dual manifestation of both skin and joint diseases. In this study, we employed both generic and disease-specific

6 Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort 31 measures. As expected the skin disease-specific QoL scores of the DLQI were highly correlated with BSA (.62, p <.01), but correlated to a lesser extent with disease duration (.33, p <.05). The DLQI scores were not significantly associated with joint distribution (polyarthritis or spondylitis). Still BSA, disease duration, and SF-36 scores were the best predictors of DLQI scores in early PSA patients. The results support our hypothesis that BSA is associated with QoL perception in early PSA patients. In addition, we found that skin and joint disease duration is associated with DLQI scores. The SF-36 mental domain summary score was a better predictor than the SF-36 physical domain summary scores in these patients. This emphasizes the psychological component influencing PSA and supports our hypothesis that even in early PSA patients, the disease has a significant impact on not only patients physical health, but their mental health as well. We acknowledge that there are some limitations in our study. The small number of patients to assess QoL scores at this time in our study is an important limitation. However as we continue to add patients to our cohort we hope to reinforce our findings using a larger patient group is needed. We also looked at these patients quality of life at a specific point of time (there first study visit). A better understanding of the impact of the skin and joint disease and the interplay between them may come to light. Also the serial assessments will hopefully shed a light on the effect of various therapies on QoL in PSA patients in early stages of the disease. In conclusion, we feel that PSA has a significant impact on QoL even in early stages. QoL scores are related to skin disease manifestations (BSA), disease duration, and mental domain summary scores, as measured by the SF-36. This implies that including QoL measures in the assessment of patients with early PSA onset is important and may provide a more comprehensive view of the disease and better outcomes for these patients. Table 1: Characteristics of Patients with PSA and Disease Characteristics

7 Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort 32 (Min-Max) Total Patients 48 Gender Distribution Females 29 Males 19 Age (years) 48 (28-70) Mean age at diagnosis of 44 psoriasis PSA Disease duration (months) BSA affected (%) Skin involvement (%) Skin H 1.5 (0-10) Skin T 1.6 (0-15) Skin UE 1.3 (0-30) Skin LE 2.2 (0-50) Table 2: Intercorrelations between QoL measures and disease characteristics Variables DLQI SF Physical 1. SF Mental 1. HAQ Patient Age 1. BSA 1. DSPSA p <.05, p <.01 Abbreviations: DLQI= Dermatology Life Quality Index; SF-36 Physical = Short Form 36 Health Survey physical domain summary score; SF-36 Mental= Short Form 36 Health Survey mental domain summary score; HAQ= Health Assessment Questionnaire; BSA= body surface area; SkinH= percentage of skin involvement of the head; DSPSA = duration of symptoms of PSA; SkinT= percentage of skin involvement of the trunk; SkinUE= percentage of skin involvement of the upper extremity; SkinLE= percentage of skin involvement of the lower extremity Table 3: QoL Scores Related to Disease Characteristics (N= 46)

8 Patient Reported Quality of Life in an Early Psoriatic Arthritis Cohort 33 B (SE) b R R 2 BSA 1.27* (0.39) ** SF-36 Mental -2.71* (1.21) DSPSA.935 (0.46) **.568 *p < 0.05, **p < REFERENCES

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