Pilot study of sexual dysfunction in patients with psoriasis: influence of biologic therapy.

BACKGROUND: Psoriasis is a chronic skin disease that affects 1 to 3% of the population in most industrialized countries. It is commonly associated with a variety of psychological problems including low self-esteem, depression, suicidal thoughts, and sexual dysfunction.
MATERIALS AND METHODS: WE HAVE PERFORMED A PILOT STUDY IN WHICH WE HAVE TRIED TO ASSESS THE IMPACT ON SEXUAL DYSFUNCTION IN PATIENTS WITH PSORIASIS WHO HAVE STARTED TREATMENT WITH BIOLOGICAL THERAPY USING VALIDATED INDEXES IN SPANISH: International Index of Erectile Function for men and female sexual function index in women.
RESULTS: Considering the men and women from our study, an improvement in FSFI by an average of 9.5 and 6.3 points is observed, respectively.
CONCLUSION: We considered our series as a first step for a more detailed approach to the study of sexual function in patients with psoriasis.

Introduction

Our daily clinical practice is becoming more common to complement the clinical aspects of the patients with a systematic assessment of their subjective perception about their disease. Undoubtedly, the availability of validated instruments for Spanish population (general and specific) to measure these psychological aspects in the most prevalent chronic diseases is a great contribution. Psoriasis is a chronic skin disease that affects 1 to 3% of the population in most industrialized countries. It is commonly associated with a variety of psychological problems including low self-esteem, depression, suicidal thoughts, and sexual dysfunction. These items, along with the impact related to body surface area affected, and psoriasis co-morbidities make from psoriasis, one of the states with the greatest impact on quality of life of patients suffering it, as has already been studied and published.[1] One of the aspects related to quality of life is the sexual dysfunction.[2] It is also one of the items included in the main index that evaluates the quality of life in dermatological patients (Dermatology life quality index). The introduction of biological therapies have revolutionized the management of patients with psoriasis and increased their quality of life, including sexual dysfunction problems.

In this pilot study, we have tried to assess the impact on sexual dysfunction in patients with psoriasis who have started treatment with biological therapy using validated indexes in Spanish: International Index of Erectile Function (IIEF) for men[34] and female sexual function index (FSFI) in women.[56]

Materials and Methods

Study population

We have evaluated 20 patients, 10 men and 10 women with moderate to severe psoriasis with BSA (Body surface area) over 10, PASI (psoriasis activity skin index) over 10, with poor tolerance or contraindication to systemic therapy which were going to begin biological treatment (seven men and seven women under etanercept treatment, and three men and three women under adalimumab treatment). None of the patients had been treated with acitretin, but with methotrexate or cyclosporine. Previously to the introduction of the biological therapy, all patients were just with topical treatment for 1 month, during which we applied for our routine protocol (blood count, biochemistry, urinalysis, serology for hepatitis viruses and HIV, CXR-chest X-ray, and TST-tuberculin skin test).

Those patients who had a sexually active couple were included; meanwhile, patients with pulmonary, hepatic, hematological, renal, or endocrine diseases (thyroid disease and diabetes mellitus) or under anxiolytic or antidepressant medications that may interfere with their sexual life were excluded from our study (None of our patients had a clinical diagnosis of depression). In female patients, we requested a hormone study pituitary-gonadal axis to rule out associated pathology. Considering that our study is a pilot one, we have enrolled a small number of patients. They have been included consecutively if they met the selection criteria previously reported.

Recruitment period have been extended for one year. Regarding male patients, IIEF questionnaire was used to assess sexual function (Appendix A). It was filled at baseline and at 6 months from the beginning of the treatment. Patients selected for the study had met all the PASI 75 (regardless of the biological agent used) and had not experienced adverse events that led to suspension of treatment. The results are presented as mean with corresponding Standard Deviation (confidence interval 95%). We have used student t test in order to compare the mean's differences with P value <0.05.

IIEF has an adequate sensitivity and specificity. It has been translated and validated to Spanish.[4] It is composed of 15 questions that assess the following five aspects in the last four weeks: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. It is useful to detect areas of difficulty and determine the degree of severity. The maximum score of the erectile function section is 30. Between 6 and 10 points is considered as serious dysfunction, moderate between 11 and 16, slight between 17 and 25, and finally normal erectile function if the patient get a score between 26 and 30. The total score is ranged between 7 and 70 points. The higher score reached, the better the sexuality of men is.

On female patients, FSFI test was used.[6] The FSFI (Appendix B) has an adequate sensitivity and specificity and has been translated and validated into Spanish. It is composed of 19 questions grouped into the following six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each question has 5 or 6 options, assigning a score ranging from 0 to 5. The value of each domain is multiplied by a factor determined by Rosen et al.[5] and the final result is the arithmetic sum of the different domains. The higher score reached, the better the sexuality of women is.

Results

All patients in our series had at baseline, PASI, and BSA over 10, being then, candidates for biologic therapy for psoriasis. In all cases, the treatment used was naive after a clearance period of one month from cessation of systemic therapy with either methotrexate or cyclosporine.

The average age was 38.56±3.18 years and 34.47±5.43 years for male and female patients, respectively. The remaining demographics data from our series could be appreciated in Table 1. The mean PASI in males at the beginning of treatment was 12.45. Six months later, this mean was reduced to 1.8, reaching in all cases, the PASI 75 response. We found similar results on female patients with a PASI reduction from 15.25 to 1.4.

Table 1

Demographic date from male and female patients in our study

Considering the women from our study, an improvement in FSFI by an average of 6.3 points is observed, with special modifications to the parameters of satisfaction and excitement [Table 2]. In male patients, the IIEF mean indicates a mild erectile dysfunction (22.5), which improved at 6 months of biologic therapy with an average increase of 9.5 points in the IIEF. All variations experimented for each domain are detailed in Table 3.

Table 2

Domains of female sexual function and evolution

Table 3

Domains of male sexual function and evolution

Discussion

We considered our series as a first step for a more detailed approach to the study of sexual function in patients with psoriasis. As we have previously stated, this is a pilot study. The number of patients has been small and we have included them consecutively if they met the selection criteria previously reported. However, despite the limitations that can be extracted, we believe that the results are relevant on focusing in the improvement of the sexual dimension of quality of life from our patients.

Sexual function is clearly impaired in patients with chronic diseases of all kinds, pulmonary, rheumatology, urology, etc. There are not many studies regarding the impact of psoriasis on sexual life΄s quality.[78]

Gupta and Gupta[9] in 1997 was pioneer in the study of the sexual dimension on psoriatic patients. 40.8% of patients from his research have sexual dysfunction, although alcohol abuse and depression state could condition their sexual function. For this reason, we have excluded those patients with anxiolytic or antidepressant treatment. Türel Ermertcan et al.[10] in 2006 performed his study comparing a control group with two different groups of patients suffering from psoriasis (with or without depression). They concluded that sexual function for both men and women with psoriasis is decreased compared with the control group regardless of whether or not associated with their depressive status.

In our series, we have observed a clear improvement in FSFI and IIEF rates associated with a good response to treatment with biological therapy. These results reveal the impairment of the sexual dimension in the quality of life of patients with moderate to severe psoriasis, so we consider necessary to extend the sample and the assessment of the quality of life in a generic way besides using the questionnaires exposed to explore the sexual dimension.

International index of erectile function (IIEF) questionnaire

Female sexual function index (FSFI) questionnaire