Adult genital psoriasis: An updated review for clinicians.

Genital psoriasis is a chronic inflammatory skin condition that has been reported in up to 63% of patients with psoriasis on other parts of their skin. It has a profound impact on quality of life and sexual function which is often overlooked by current severity scores. Despite its prevalence and disease burden, genital psoriasis remains largely under-reported and under-treated. Historically, this was due to the impracticality and limited efficacy data of standard psoriasis treatments when applied to genital skin. However, there have been recent advancements with several new agents currently being developed and evaluated for genital psoriasis. This clinical review aims to provide an overview of the current evidence regarding the clinical features of genital psoriasis, available management options and tools for assessing patients' quality of life. Key takeaways from this review emphasise the recognition of genital psoriasis as a chronic and debilitating condition, unique in its impact on patients' quality of life, necessitating sensitive and attentive approaches to address their needs.

Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial.

BACKGROUND: Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment. OBJECTIVE: To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis. METHODS: DISCREET, a phase 3, placebo-controlled trial (NCT03777436), randomized patients with moderate-to-severe genital psoriasis (stratified by affected body surface area <10% or ≥10%) to apremilast or placebo for a 16-week period, followed by an apremilast extension period. Week 16 results are presented. RESULTS: Patients were randomized to apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction); treatment difference was significant (20.1%, P = .0003). Improvements in genital signs and symptoms, skin involvement, and quality of life were observed. Common treatment-emergent adverse events were diarrhea, headache, nausea, and nasopharyngitis. LIMITATIONS: Lack of active-comparator. CONCLUSIONS: Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and quality of life in this first randomized, controlled study of an oral systemic treatment in patients with genital psoriasis.

Anti-interleukin-17 and anti-interleukin-23 biologic drugs for genital psoriasis: a single-center retrospective comparative study.

Genital psoriasis affects 3-33% of patients with psoriasis during the course of the disease, usually leading to a severe reduction in the patient's quality of life. This study aims to retrospectively assess the effectiveness of interleukin (IL)-23 and IL-17 inhibitors in a real-life population affected by moderate-to-severe plaque psoriasis with genital involvement coming from our dermatology department. A total of 86 patients with a diagnosis of moderate-tosevere plaque psoriasis with severe genital involvement were enrolled. Patient characteristics, psoriasis area and severity index (PASI), and static physician global assessment of genitalia (sPGAG) at each visit were recorded. During the treatment, the mean PASI decreased from 12.8 to 0.63 at week 52; a PGA of 0/1 was reached by 97.40% at week 52 and by 100% of patients (37/37) at week 104. No significant differences between IL-23 and IL-17 inhibitors were observed; indeed, the bio-naïve group of patients demonstrated a superior response compared to the group of bioexperienced patients.Our findings confirmed that IL-23 and IL-17 inhibitors are safe and effective therapeutic options for the treatment of genital psoriasis.

A Qualitative Examination of the Preferred Language for Patients Discussing Genital Psoriasis With the Physician.

Background: Psoriasis is a chronic inflammatory disease that may affect the genitalia in up to 60% of patients. This is a significant concern to patients; however, they may be too embarrassed to report genital involvement or seek help for it spontaneously. Information on preferred language that would put patients more at ease discussing disease in sensitive areas is lacking. Objective: To address language as a barrier to care in patients with psoriasis by identifying preferred terminology when discussing genital involvement of the disease with physicians. Methods: A qualitative study was performed that consisted of one-on-one interviews with patients with psoriasis; thematic analysis was used to analyze the data. Results: Themes included (1) personal experience with genital psoriasis; (2) timespan between genital psoriasis symptom onset and diagnosis; (3) patient-provider communication; (4) patient-provider preference, and (5) patient terminology preference. Conclusion: Our study highlights providers' failure to ask psoriasis patients about genital involvement of the disease and variation in patient response on preferred language when discussing sensitive topics. Dermatologists may need to be cognizant of the patient's comfort level using verbal and nonverbal communication and tailor their approach to the individual.

Genital Psoriasis: A Prospective, Observational, Single-Centre Study on Prevalence, Clinical Features, Risk Factors, and Its Impact on Quality of Life and Sexual Health.

Background: Genital psoriasis is often under-recognized and the exact burden is unknown in Malaysia. Objectives: To identify the prevalence of genital psoriasis, its clinical features, risk factors, and impact on quality of life and sexual health. Methods: This prospective, observational study was conducted in the dermatology clinic of our hospital from 1st September 2020 until 31st March 2021, involving all adult patients with psoriasis. The genital examination was performed and the subjects were interviewed using questionnaires. Results: A total of 262 patients were recruited, with a male to female ratio of 1.5:1 (mean age of 51 years old). They comprised 42.0% Chinese, followed by 36.6% of Malay, 21.4% of Indians and others. Up to 46.1% of patients had a current or history of genital psoriasis. The most common area involved for males was the scrotum (44.1%) and labia majora (62.5%) for female patients. Itching (79.2%) was the most frequent symptom encountered. Chinese patients had 2.67 times odd (CI 1.55-4.61) of having genital psoriasis compared to non-Chinese patients. Other independent risk factors included flexural involvement, male gender, and Type 1 psoriasis. Genital psoriasis was associated with greater impairment on quality of life and sexual health (mean total Dermatology Life Quality Index: 8.8 vs 6.5, P = 0.006), International Index of Erectile Function (mean: 48.5 vs 57.0, P = 0.011) and revised version of Female Sexual Distress Scales (mean: 20.7 vs 11.4, P = 0.022). Conclusions: Genital psoriasis is common and it has a profound impact on patients.

Non-venereal genital dermatoses and their impact on quality of life-A cross-sectional study.

BACKGROUND: Lesions on the external genitalia could be venereal or non-venereal. Non-venereal genital dermatoses are common and may cause considerable anxiety to patients, particularly if noticed after sexual intercourse. However, this aspect has not been studied much till now. OBJECTIVES: Our study proposes to describe the profile of non-venereal genital dermatoses and determine their impact on quality of life both social and sexual, using the dermatology life quality index questionnaire. METHODS: We recruited patients aged 18 years and above, who were diagnosed to have non-venereal genital dermatoses during the study period. A detailed history was obtained and clinical examination done with relevant investigations when necessary. The dermatology life quality index was assessed and graded in all patients using Finlay dermatology life quality index questionnaire. RESULTS: A total of 293 patients with non-venereal genital dermatoses were seen and 25 different dermatoses were observed. Men 242(82.6%) outnumbered women. The commonest age group affected was 31-50 years 144(50%). Chronic inflammatory dermatoses 135(41.6%) constituted the majority of cases. Scrotal dermatitis 46(15.7%), lichen simplex chronicus 37(12.6%), vitiligo 31(10.6%) were seen most frequently. In the study group, 111(37.9%) patients had moderate and 133(45.4%) had large impact on the quality of life. Erectile dysfunction was seen in 48(19.8%) men and 9(3.7%) had premature ejaculation. A significant effect on dermatology life quality index was found with increasing age (P = 0.007), positive marital status (P = 0.006), history of unprotected sex (P < 0.001), history of recurrences (P = 0.002) and venereophobia. (P = 0.008). LIMITATIONS: The number of women in the study group was less compared to men and we could not ascertain the type of sexual dysfunction in them. CONCLUSION: Non-venereal genital dermatoses are common, more so among men. They have a significant impact on the quality of life of the individual. Recognizing and addressing this problem will help in managing these patients effectively.

Evaluation of treatment satisfaction misalignment between Japanese psoriasis patients and their physicians - Japanese psoriasis patients and their physicians do not share the same treatment satisfaction levels.

OBJECTIVES: High treatment satisfaction in both patients and physicians is an important factor in improving quality of life in psoriasis patients. This study aimed to evaluate treatment satisfaction alignment between psoriasis patients and physicians and to identify factors associated with satisfaction misalignment, especially "physician-predominant" misalignment. METHODS: This is a nationwide multicenter cross-sectional study. Subjects were paired moderate to severe psoriasis outpatients and their physicians. Treatment satisfaction was evaluated on a scale from 0 to 10. Subjects were defined as "misaligned" when the difference in treatment satisfaction was over ±1 between the patient-physician pair. RESULTS: A total of 425 pairs were collected from 54 facilities in Japan. The mean patient age and disease duration were 56.5 years and 18.7 years, respectively. The mean physician age was 50.6 years and 69.6% of physicians specialized in psoriasis. Treatment satisfaction misalignment was found in 49.9% of the patient-physician pairs. Among misaligned pairs, 43.6% were "physician-predominant" pairs. In the multivariate logistic regression analyses, "treatment is effective" was the most important reason for treatment satisfaction (odds ratio [OR]: 35.5; 95% confidence interval [CI]: 5.43, 231.78). Symptoms in the genital area (OR: 10.2; 95% CI: 2.55, 40.93) and lack of understanding of treatment options by patients (OR: 7.5; 95% CI: 2.19, 25.94) were key factors leading to "physician-predominant" status. CONCLUSIONS: The results suggest that genital psoriasis plays an important role in treatment satisfaction from the patient perspective, and illustrate the importance of communication between patients and physicians which potentially resolves these factors and improves misalignment.

A Randomized Controlled Ixekizumab Vs Secukinumab Trial to Study the Impact on Sexual Activity in Adult Patients with Genital Psoriasis.

Introduction: There is limited data on the effects of biologic therapies on genital psoriasis and sexual activity. Recently, Ixekizumab was reported to be effective. Aim: To compare the efficacy of ixekizumab and secukinumab for the treatment of genital psoriasis and sexual inadequacy in adult patients with moderate-to-severe psoriasis. Patients and methods: We assessed adult patients with moderate-to-severe psoriasis having genital involvement. They were randomly assigned in a 1:1 ratio to receive either ixekizumab (80 mg/2 weeks after 160-mg initial dose) or secukinumab (300 mg subcutaneous injection at Weeks 0, 1, 2, 3, and 4 then every 4 weeks). The severity was assessed using Genital Psoriasis Symptoms Scale (GPSS), and impact on sexual health by evaluating the Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ). Results: Twenty eight patients on ixekizumab, and 26 on secukinumab showed improvement in genital psoriasis symptoms, beginning week 2 (GPSS total and individual items), and from week 4 onwards, improvement in sexual activity was seen with both drugs. Conclusion: Both genital psoriasis symptoms and impact on sexual activity improved rapidly and significantly with both the IL-17 inhibitors. Limitations included small number of patients and lack of follow-up period.

Genital Psoriasis and Associated Factors of Sexual Avoidance - A People-centered Cross-sectional Study in Germany.

Patients with genital psoriasis show poorer outcomes regarding quality of life and sexual distress than those without. This study aimed to assess the occurrence of genital psoriasis and to determine factors associated with the avoidance of sexual activities due to psoriasis in a non-clinical setting. A cross-sectional, person-centered, and online-based nationwide survey was conducted in Germany between March and June 2019. A multiple logistic regression model was used to analyze the data. Furthermore, free-text answers were provided. Overall, 344 individuals with psoriasis participated. Of these, 198 (57.6%) reported having genital psoriasis and 261 (75.9%) currently received medical care. Duration of psoriasis, subjective overall severity, and pain during sex were associated with the avoidance of sexual activities. Most prevalent reasons to avoid sexual activities were 'shame,' 'pain,' and 'fear of rejection.' Sexual distress was high in this sample and a person-centered care approach needs to be further promoted.

[Intertriginous psoriasis]. / Psoriasis intertriginosa.

Intertriginous psoriasis is a variant of psoriasis that is associated with inflammatory lesions in skin folds. Patients often feel ashamed, are subjected to stigmatization, social isolation, or experience mental health issues. There is no general consensus on the definition of intertriginous psoriasis. Depending on the definition used, the prevalence varies substantially. Due to the particular location of skin lesions, therapeutic management is very challenging. Mild symptoms can be treated with topical corticosteroids or topical immunomodulators. There are encouraging data demonstrating the efficacy of ixekizumab, possibly charting the way for it to become a systemic treatment option.

Crisaborole 2% ointment for the treatment of intertriginous, anogenital, and facial psoriasis: A double-blind, randomized, vehicle-controlled trial.

BACKGROUND: Psoriasis of the intertriginous, anogenital, and facial regions remains a therapeutic challenge, with current algorithms lacking a topical agent that exhibits both high efficacy and minimal side effects. OBJECTIVE: To assess the safety and efficacy of crisaborole 2% ointment-a nonsteroidal phosphodiesterase 4 inhibitor-in the treatment of intertriginous, anogenital, and facial psoriasis. METHODS: A double-blind, randomized, vehicle-controlled trial was conducted in 21 participants. Participants were randomized 2:1 to receive 4 weeks of twice-daily treatment with either crisaborole 2% ointment (n = 14) or vehicle ointment (n = 7), followed by 4 weeks of open-label treatment with crisaborole 2% ointment. Disease severity was measured by using the Target Lesion Severity Scale (TLSS). RESULTS: After 4 weeks, participants in the crisaborole group demonstrated 66% improvement compared with 9% in the vehicle group (P = .0011). Participants in the crisaborole group continued to experience improvement through the open-label phase, demonstrating 81% lesional improvement by week 8, with 71% of these participants achieving clinical clearance. There were no adverse events. LIMITATIONS: The study was limited to a single tertiary care center and small sample size. CONCLUSION: Treatment with crisaborole 2% ointment was well-tolerated and led to clinical improvement in participants with intertriginous, anogenital, or facial psoriasis.

Treatments for inverse psoriasis: a systematic review.

Background: Inverse psoriasis often requires a targeted treatment strategy due to the inherent sensitivity, thinness, and occlusion of flexural areas. However, most treatment recommendations are based on anecdotal evidence.Methods: A systematic literature search was conducted in October 2018 in Pubmed, Scopus, Embase, and Cochrane Library with keywords 'inverse psoriasis,' 'genital psoriasis,' and 'treatment.' All prospective studies assessing efficacy of treatments for inverse psoriasis that had a sample size of at least 10 patients were included in our analysis.Results: The initial search yielded 340 results, and 14 studies were included in the final analysis. These studies comprised over 1000 patients with mild to severe psoriasis involving axillary, inframammary, facial, and/or anogenital regions. The included studies demonstrated efficacy of topical immunomodulators (N = 7), vitamin D analogs (N = 4), topical corticosteroids (N = 3), antiseptics (N = 2), and biologics (N = 1) in improving genital and flexural psoriasis symptoms.Conclusions: There is a paucity of high-quality studies on which to base treatment recommendations, especially with regard to the role of systemic and biologic therapies. Few studies, many of which are of low evidence quality, suggest that topical immunomodulators, vitamin D analogs, and mid-to-high-potency topical corticosteroids may be effective treatments, but more randomized controlled trials are needed.

Ixekizumab Results in Persistent Clinical Improvement in Moderate-to-Severe Genital Psoriasis During a 52 Week, Randomized, Placebo-Controlled, Phase 3 Clinical Trial.

Ixekizumab was efficacious in treating moderate-to-severe genital psoriasis over 12 weeks. We evaluated the long-term efficacy and safety of ixekizumab for up to 52 weeks. Patients were randomized to 80 mg ixekizumab every 2 weeks or to placebo through Week 12, then received 80 mg open-label ixekizumab every 4 weeks through Week 52. In patients initially randomized to ixekizumab, clear or almost clear genital skin was achieved for 73% of patients at Week 12 and 75% at Week 52. Persistent improvements were also observed for overall psoriasis, genital itch, and the impact of genital psoriasis on the frequency of sexual activity. The safety profile was consistent with studies of ixekizumab in patients with moderate-to-severe plaque psoriasis. Ixekizumab provided rapid and persistent improvements in the signs and symptoms of genital psoriasis for up to 52 weeks of treatment.

Ixekizumab Improved Patient-Reported Genital Psoriasis Symptoms and Impact of Symptoms on Sexual Activity vs Placebo in a Randomized, Double-Blind Study.

INTRODUCTION: Genital psoriasis (GenPs) is common and distressing for patients, but is often not discussed with physicians, and no previous clinical trials have assessed the effects of biologics specifically on GenPs and its associated symptoms. AIM: To report results for novel patient-reported outcomes (PROs) for the assessment of symptoms and the sexual impact of GenPs before and after treatment in the IXORA-Q study. METHODS: IXORA-Q (NCT02718898) was a phase III, randomized, double-blind, placebo-controlled study of ixekizumab (80 mg/2 weeks after 160-mg initial dose) vs placebo for GenPs. Men and women ≥18 years old with moderate-to-severe GenPs and body surface area (BSA) ≥1% were assessed through 12 weeks. MAIN OUTCOME MEASURE: GenPs symptoms were assessed using the 8-item Genital Psoriasis Symptoms Scale (GPSS), Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ), and Genital Psoriasis Sexual Impact Scale (GPSIS) (validation data presented in the supplemental materials), and the Dermatology Life Quality Index (DLQI) item 9. RESULTS: For patients receiving ixekizumab (N = 75) vs placebo (N = 74), statistically significant improvement in GenPs symptoms were seen from week 1 onward (GPSS total and individual items, all P < .005). Sexual activity avoidance owing to GenPs symptoms (GPSIS) decreased significantly with ixekizumab from week 4 onward (all P <.005), whereas impact of sexual activity on GenPs improved significantly with ixekizumab at weeks 2-8 (all P < 0.05). Ixekizumab resulted in significant improvement vs placebo by week 1 onward in limitations on frequency of sexual activity owing to GenPs (GenPs-SFQ item 2). Sexual difficulties caused by skin (DLQI item 9) decreased significantly with ixekizumab from week 2 onward (all P < .001). CLINICAL IMPLICATIONS: Both GenPs symptoms and impact on sexual activity improved rapidly and significantly with ixekizumab vs placebo through 12 weeks in patients with moderate-to-severe GenPs and BSA ≥1%. STRENGTH & LIMITATIONS: To our knowledge, this is the first phase III, randomized, placebo-controlled, double-blinded clinical trial to evaluate the effect of any treatment on the symptoms and sexual impact related to GenPs. The study did not include an active comparator owing to the lack of any well-established treatment for moderate-to-severe GenPs, and the period assessed herein was of relatively short duration. CONCLUSION: These validated PRO measures may aid in future clinical studies of GenPs and in facilitating discussions of GenPs symptoms and their impact between patients and clinicians. Yosipovitch G, Foley P, Ryan C. Ixekizumab improved patient-reported genital psoriasis symptoms and impact of symptoms on sexual activity vs placebo in a randomized, double-blind study. J Sex Med 2018;15:1645-1652.

The impact of genital psoriasis on quality of life: a systematic review.

Psoriasis is a chronic immune-mediated inflammatory disease with significant medical and psychological comorbidities. In addition to having increased cardiovascular risk and mortality, psoriasis patients are more likely to be depressed, anxious, and endorse suicidal ideation than the general population. These patients often have low self-esteem and feel stigmatized due to their skin disease, which can prevent them from pursuing relationships, dating, and attending social activities. Up to 63% of adult psoriasis patients experience psoriatic lesions on their genital area during their lifetime, but often do not discuss these issues with their physicians due to embarrassment, stigmatization, or shyness about this sensitive location. However, psoriasis in sensitive areas, such as the genitals, may result in quality of life impairment greater than that of patients with psoriasis elsewhere on their body, particularly in respect to romantic relationships, intimacy, and sexual function. This article evaluates the current literature regarding the impact of genital psoriasis on the quality of life of affected patients.

Treatment of Genital Psoriasis: A Systematic Review.

Genital psoriasis affects approximately 63% of psoriasis patients at least once in their lifetime. More than any other area on the body, genital lesions significantly impair patients' psychologic well-being and quality of life. We aimed to systematically review the published evidence on the safety, efficacy, and tolerability of treatments of genital psoriasis and synthesize the available clinical data. A total of 1 randomized controlled trial, 11 open-label studies, and 26 case reports were included in our analysis, representing a total of 458 patients, of which 332 were adults and 126 were children. Topical corticosteroids were commonly used first-line for genital psoriasis and were well tolerated. Nonsteroidal agents, such as topical calcineurin inhibitors or vitamin D analogs, were also efficacious, but were often irritating. One systemic agent, ixekizumab, demonstrated efficacy in reducing genital psoriasis symptoms in a large, randomized, placebo-controlled trial. Various systemic and topical medications may improve genital psoriasis lesions, but there is a lack of high-quality evidence to guide clinical decision-making. Specific reporting of efficacy for genital psoriasis in larger controlled studies of psoriasis treatments are necessary to improve the available evidence regarding the optimal treatment regimen for genital psoriasis.

Prevalence of genital psoriasis in patients with psoriasis.

BACKGROUND: Psoriatic lesions in the genital area (GenPs) can cause considerable physical and emotional distress. To increase physician awareness, we estimated the GenPs prevalence among patients with psoriasis. METHODS: An English language literature search was performed. Articles reporting GenPs prevalence met the search criteria and were included. Because GenPs is rarely reported in demographics of prospective clinical trials, GenPs prevalence and baseline demographics of patients with and without GenPs in two prospective randomized phase 3b trials (NCT02561806 and NCT02634801) involving patients with moderate-to-severe psoriasis are reported. RESULTS: Overall, 600 references were screened. Eighteen articles met the search criteria. Patient populations were highly heterogeneous across articles. Broadly, the presence of GenPs was either physician-reported (physical examinations) or patient-reported (questionnaires). In the literature, GenPs prevalence at the time of reporting ranged from 7% to 42% and the prevalence of GenPs at any time during the course of psoriasis ranged from 33% to 63%. In the two prospective clinical trials, the prevalence of GenPs at the time of enrollment was 35-42%. CONCLUSION: A substantial proportion of patients experience genital lesions at some time during the course of psoriasis. Increased awareness of GenPs prevalence may drive improved assessment and treatment.

Psoriasis in special localizations.

Psoriasis is a chronic inflammatory dermatosis affecting 1-3% of the general population. Patients with psoriasis represent a heterogeneous population with individual disease expression - different degrees and severity of skin involvement. Psoriatic lesions in particular localizations such as the face, scalp, intertriginous or palmoplantar areas significantly reduce quality of life. Patients often feel ashamed, embarrassed, or self-conscious about their symptoms. Furthermore, genital psoriasis significantly affects sexual health. Among patients with psoriasis, the prevalence of special localizations is estimated to be 23-27% on the nails, 49% on the face, 12-16% on the palms and soles, and up to 36% in intertriginous regions. Due to peculiar features of skin in these areas, adequate and specific management is required, which is discussed in this review.

The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms: The Genital Psoriasis Symptoms Scale (GPSS).

INTRODUCTION: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. METHODS: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs. RESULTS: Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS. CONCLUSION: The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs. FUNDING: Eli Lilly & Company. Plain language summary available for this article.