Eur J Dermatol 2014; 24(6): 662-9

Investigative report Francisco VANACLOCHA1 ´ 2 Isabel BELINCHON ´ José L. SANCHEZ-CARAZO3 Raquel RIVERA1 José M. CARRASCOSA4 Luis CEA-CALVO5 ´5 Berta JULIA Lluìs PUIG6 1

Dpt Dermatology, Hospital 12 de Octubre, Av de Córdoba, s/n, 28041 Madrid, Spain 2 Dpt Dermatology, Hospital General Universitario, Alicante, Spain 3 Dpt of Dermatology, Hospital General Universitario, Valencia, Spain 4 Dpt of Dermatology, Hospital Germans Trias i Pujol, Badalona, Spain 5 Medical Affairs, Merck Sharp & Dohme of Spain, Josefa Valcárcel 38, 28027 Madrid, Spain 6 Dpt of Dermatology, Hospital de la St Creu i S Pau, Barcelona, Spain

Reprints: L. Cea-Calvo

Article accepted on 7/23/2014

D

Cardiovascular risk factors and cardiovascular diseases in patients with moderate to severe psoriasis under systemic treatment. PSO-RISK, descriptive study Background: The prevalence of cardiovascular risk factors (CVRF) in psoriasis has not been studied in large Spanish samples. Objective: To assess the prevalence of major CVRFs in psoriasis patients requiring systemic treatments. Material and Methods: Cross-sectional study in psoriasis patients from 33 hospital dermatology offices throughout Spain. Blood pressure (BP) was measured and a fasting lab test was performed. Each CVRF was diagnosed according to the recommendations of international societies. Results: In 368 patients (mean age 48 years old, 36% women), 80.2% had at least one CVRF. The prevalence of each CVRF was similar in men and women and slightly higher in patients with psoriatic arthritis and in patients with a history of more severe disease. The percentage of patients treated with drugs to control CVRF was low (∼50% of those with each CVRF). A total of 20.7% had experienced some cardiovascular disease (CVD) episode. Conclusion: The prevalence of CVRF was high, higher than in the general Spanish population, and 20% had already suffered CVD. However, the percentage with drug treatments for CVRF was low. Key words: cardiovascular disease, cardiovascular risk factors, psoriasis, prevalence

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their control. In Spain, however, no studies have systematically evaluated the prevalence CVRF and CVD in patients with psoriasis. The primary objective of the PSO-RISK study (Psoriasis and Cardiovascular Risk) was to assess the prevalence of obesity and other CVRFs, as well as the prevalence of CVD in patients with psoriasis receiving systemic treatment.

Patients and methods The PSO-RISK study was a cross-sectional, multicenter, non-interventional study involving 33 investigators from dermatology clinics of representative hospitals throughout Spain. The study was approved by the corresponding clinical research ethics committees. Data were collected between February and October 2012 and each investigator enrolled 10-12 patients. The primary study objective was to assess the proportion of patients with obesity and major CVRF (hypertension, hypercholesterolemia, diabetes mellitus and smoking). The secondary objectives included evaluation of the prevalence of established CVD.

Selection of participating subjects Patients from hospital dermatology clinics were consecutively screened to reduce inclusion bias and were included EJD, vol. 24, n◦ 6, November-December 2014

To cite this article: Vanaclocha F, Belinchón I, Sánchez-Carazo JL, Rivera R, Carrascosa JM, Cea-Calvo L, Juliá B, Puig L. Cardiovascular risk factors and cardiovascular diseases in patients with moderate to severe psoriasis under systemic treatment. PSO-risk, descriptive study. Eur J Dermatol 2014; 24(6): 662-9 doi:10.1684/ejd.2014.2440

doi:10.1684/ejd.2014.2440

ifferent studies have shown that patients with psoriasis have a high prevalence of cardiovascular risk factors (CVRF) [1-3]. In fact, it is debated if psoriasis must be considered an independent CVRF in itself [4], as an increased risk of cardiovascular disease (CVD) has been reported for psoriasis patients, independently of the presence of CVRF in some studies [5-7] but not in others [8, 9]. On the other hand, evaluation of CVRF is important for the management of psoriasis. Some studies have revealed an association between body mass index (BMI) and the severity of psoriasis [10], obese patients being susceptible to psoriasis of greater severity. A poorer response to treatment has also been described in obese patients, particularly when biological agents are used at fixed doses and not adjusted to weight [11, 12], and increased BMI has been associated with an increased risk of treatment discontinuation due to lack of effectiveness [13]. Moreover, some therapies frequently used for psoriasis can have deleterious effects on CVRF [14, 15], which warrants careful evaluation and follow-up in this regard. Psoriasis is a disease that generally develops before 30 years of age, though with a second incidence peak at about 5560 years of age [1, 16, 17]. Many patients are young and possibly have never been evaluated for CVRF at the time of visiting the dermatologist. The dermatologist therefore may play an important role in the detection of CVRF and can work with primary care or other specialists to secure

in the study after signing an informed consent form. The study included patients 18 years or older with an established diagnosis of psoriasis requiring systemic treatment (whether biological or otherwise). Patients could be receiving systemic treatment or be prescribed such treatment at the time of inclusion in the study. We excluded patients with mental disorders precluding correct interpretation of the results or participation in the study, patients with concomitant serious disease implying a short life expectancy or an unfavorable baseline situation according to the criterion of the investigator and patients who were participating in another study.

Procedures After inclusion of the subject in the study, data collection was carried out in a structured manner based on a direct interview, a review of the medical history, and a physical examination. Demographic data (age and sex) and anthropometric parameters (weight (kg), height (cm) and abdominal circumference (cm)) were recorded. Weight and height were registered using equipment available at the hospital; patients were weighed without shoes and wearing light clothing, rounding values to the nearest 0.1 kg and 1 cm, respectively. Waist circumference was measured with the patient standing, at the midpoint between the iliac crest and the costal margin on the mid-axillary line. Blood pressure (BP) was obtained at each center using validated devices and a cuff size adapted to the arm circumference. BP recordings were made twice and spaced one minute apart, taking the average of both values as representing the true BP of the patient [18]. Laboratory data were collected from a blood test performed under fasting conditions. Clinical manifestations of psoriasis were documented. Disease activity was assessed by physical examination, calculating the Psoriasis Area Severity Index (PASI). The medication used by the patient for psoriasis was recorded by therapeutic groups (topical, systemic non-biological and biological treatments). Finally, the following variables were defined to characterize patients with a history of more severe psoriasis: a) moderate or severe psoriasis activity in the past; b) active disease >50% of the time; c) >50% of time needing systemic therapies or phototherapy and d) history of hospitalizations due to psoriasis.

Definition of the main variables The CVRF analyzed for the primary study objective were smoking, obesity, hypertension, hypercholesterolemia and diabetes mellitus (DM). In addition, information was collected on HDL-cholesterol, triglycerides and abdominal waist circumference, as well as lifestyle (active or sedentary) and a family history of early CVD. Evaluation of CVRF was made in accordance with the definitions of the scientific societies, considering the data collected from the medical history, physical examination and laboratory tests. Obesity was defined by a body mass index (BMI) ≥30 kg/m2 , while overweight was defined as BMI≥25 and 250 mg/dL (6.45 mmol/L). In the case of patients with DM or CVD, hypercholesterolemia was defined as >200 mg/dL (5.17 mmol/L) [20]. A patient was considered to have DM if he or she met any of the criteria of the American Diabetes Association: glycosylated hemoglobin (HbA1c) ≥6.5%; fasting blood glucose ≥126 mg/dL (7.0 mmol/L); 2-hour blood glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose overload test; or randomized blood glucose ≥200 mg/dL (11.1 mmol/L) in a patient with classical hyperglycemic symptoms or hyperglycemic episodes [21]. The data were collected from the laboratory tests performed in the clinic but oral glucose overload was not performed as a diagnostic test for DM. The presence of CVD was assessed using the data collected from the medical history of the patients. The following were recorded: coronary disease (history of myocardial infarction, angina or coronary revascularization), cerebrovascular disease (history of stroke or transient ischemic attack), heart failure and peripheral arterial disease (diagnosis of intermittent claudication or peripheral artery revascularization).

Statistical analysis For the calculation of sample size, the prevalence of obesity and other CVRF of 30% were estimated. Assuming a confidence level of 95% and a precision of 5%, the sample size required for analysis was found to be 323 patients. The sample size was increased by 10% to compensate for cases in which the variables were not correctly collected, or in which patients were excluded due to other reasons (total sample size: 359 patients). Descriptive methods and estimations based on standard confidence intervals were used for the uni- and bivariate analyses. The chi-squared test, linear trend chi-squared test or Fisher exact test was used for the comparison of proportions. Given the basically descriptive nature of the study, no multiplicity global alpha adjustments were made. Rather than being conclusive, the results of the inferential tests should be regarded as exploratory.

Results Descriptive data Three hundred and sixty-eight patients were enrolled into the study: 133 women (36.1%) and 235 men (63.9%), with a mean age of 48.4 years (SD 14.1). A total of 43.2% were patients under 45 years of age (n = 159). The median duration of psoriasis was 18 years (interquartile range (IQR): 10-25), and 53.3% had a family history of the disease. The most common diagnosis was plaque psoriasis (95.9%). The median PASI score on the study visit was 2.7 (IQR 25-75: 0.9-6.8). A total of 22.8% had psoriatic arthritis. Most patients were receiving or had received systemic treatment, including immune modulators and/or biological drugs. Table 1 completes the description of the sample.

Prevalence of cardiovascular risk factors and therapies A total of 80.2% (95%CI: 75.8-83.9) had at least one of the major CVRF (smoking, obesity, hypertension, hyperc-

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Table 1. Characteristics of the 368 patients included in the PSO-RISK study.

Age Sex Body mass index (classification)

Smoking Lifestyle

Family history of psoriasis

Classification of psoriasis (most frequent)

Location of psoriasis (most frequent)

Comorbidities Treatments received up until inclusion in the study

Men Women Obesity Normal weight Overweight Smoker Ex-smoker Sedentary Active Not documented Yes No Not documented Plaque Guttate Inverted Pustular Elbows Knees Trunk Sacrum Acral Scalp Psoriatic arthritis Topical Non-biological immune suppressor Biological agent Anti-TNF-alfa Non-anti-TNF-alfa

Mean

SD

48.4 Number 235 133 119 92 157 111 79 194 167 7 196 136 36 353 32 39 6 303 279 287 201 161 242 84 306 292 228 185 43

14.05 Proportion 63.9% 36.1% 32.3% 25.0% 42.7% 30.2% 21.5% 52.7% 45.4% 1.9% 53.3% 37.0% 9.9% 95.9% 8.7% 10.6% 1.6% 82.3% 75.8% 78.0% 54.6% 43.8% 65.8% 22.8% 83.2% 79.3% 62.0% 50.3% 11.7%

SD: standard deviation

Table 2. Number and proportion of subjects with cardiovascular risk factors. No CVRF

All (n = 368) Men (n = 235) Women (n = 133)

73 (19.8%) 41 (17.4%) 32 (24.1%)

At least one CVRF

295 (80.2%) 194 (82.6%) 101 (75.9%)

Number of CVRFs 1

2

3

4

5

107 (29.1%) 69 (29.4%) 38 (28.6%)

100 (27.2%) 64 (27.2%) 36 (27.1%)

64 (17.4%) 47 (20.0%) 17 (12.8%)

21 (5.7%) 11 (4.7%) 10 (7.5%)

3 (0.8%) 3 (1.3%) 0 (0.0%)

The table displays the number of patients and the percentage in each category. CVRF: Cardiovascular risk factors. The 5 cardiovascular risk factors considered are: obesity, smoking habit, arterial hypertension, hypercholesterolemia and diabetes mellitus

holesterolemia and DM). The mean number of CVRF was 1.6 (SD: 1.2), with a median of 2 (IQR 25-75: 1-2). A total of 29.1% had one CVRF, 27.2% had two CVRF, 17.4% had three CVRF, 5.7% had four CVRF and 0.8% had all 5 of the above-mentioned CVRF. The distribution of the number of CVRF was similar in men and women (table 2), and 82.6% of the men (95%CI: 77.2-86.9) and 75.9% of the women had at least one CVRF (95%CI: 68.0-82.4).

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A total of 30.2% of the patients (95%CI: 25.7-35.0) were active smokers, while 21.5% were ex-smokers. In turn, 32.3% (95%CI: 27.8-37.3) were obese (BMI ≥ 30 kg/m2 ) and 42.7% were overweight (BMI 25-29.9 kg/m2 ). Only 25.0% of the patients showed weights within the normal range. A total of 154 patients (41.8% (95%CI: 36.947.0)) had been previously diagnosed with hypertension or showed high office BP and, of these, only 84 (54.5%) were EJD, vol. 24, n◦ 6, November-December 2014

Table 3. Prevalence of cardiovascular risk factors by age and sex.

Smokers

Obesity

Arterial hypertension

Hypercholesterolemia

Diabetes mellitus

All Men Women All Men Women All Men Women All Men Women All Men Women

30.2% 31.5% 28.0% 32.3% 34.0% 29.3% 41.8% 45.1% 36.1% 41.6% 40.4% 43.6% 16.6% 17.9% 14.3%

0.05 for all comparisons). The percentages of patients with antihypertensive, lipid-lowering or antidiabetic therapy were also similar in men and women. In addition to the above, 52.7% of the subjects reported a sedentary lifestyle (patients who do not walk regularly, e.g., 20-30 minutes a day, or perform any type of exercise), and 15.8% had a family history of early CVD (father, mother, male or female sibling with coronary disease, myocardial infarction or sudden death before 55 years (men) or 65 years of age (women)). Some 29.8% had low HDL-cholesterol levels (26.7% of the men had levels < 40 mg/dL and 35.4% of the women had levels

Cardiovascular risk factors and cardiovascular diseases in patients with moderate to severe psoriasis under systemic treatment. PSO-RISK, descriptive study.

The prevalence of cardiovascular risk factors (CVRF) in psoriasis has not been studied in large Spanish samples...
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