Psychotropic medicines' prevalence, patterns and effects on cognitive and physical function in older adults with intellectual disability in Ireland: longitudinal cohort study, 2009-2020.

BACKGROUND: The frequent prescribing of psychotropics and high prevalence of polypharmacy among older adults with intellectual disabilities require close monitoring. AIMS: To describe change in prevalence, predictors and health outcomes of psychotropic use during the four waves (2009/2010, 2013/2014, 2016/2017, 2019/2020) of the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). METHOD: Eligible participants were adults (≥40 years) with intellectual disabilities who participated in all four waves of IDS-TILDA and who reported medication use for the entire period. Differences between groups were tested using Cochran's Q test for binary variables and the McNemar-Bowker test for variables with more than two categories. Generalised estimating equation models were used to assess associations between psychotropic use, participants' characteristics and health outcomes. RESULTS: Across waves (433 participants) there were no significant differences in prevalence of psychotropic use (61.2-64.2%) and psychotropic polypharmacy (42.7-38.3%). Antipsychotics were the most used subgroup, without significant change in prevalence between waves (47.6-44.6%). A significant decrease was observed for anxiolytics (26.8-17.6%; P < 0.001) and hypnotics/sedatives (14.1-9.0%; P < 0.05). A significant increase was recorded for antidepressants (28.6-35.8%; P < 0.001) and mood-stabilising agents (11.5-14.6%; P < 0.05). Psychotropic polypharmacy (≥2 psychotropics) was significantly associated with moderate to total dependence in performing activities of daily living over the 10-year period (OR = 1.80, 95% CI 1.21-2.69; P < 0.05). CONCLUSIONS: The study indicates an increase in usage of some classes of psychotropic, a reduction in others and no change in the relatively high rate of antipsychotic use over 10 years in a cohort of older adults with intellectual disabilities and consequent risk of psychotropic polypharmacy and medication-related harm.

Does Arterial Stiffness Predict Cardiovascular Disease in Older Adults With an Intellectual Disability?

BACKGROUND: Arterial stiffness has been associated with an increased risk of cardiovascular disease (CVD) in some patient populations. OBJECTIVES: The aims of this study were to investigate (1) whether there is an association between arterial stiffness, as measured by the Mobil-O-Graph, and risk for CVD in a population of individuals with intellectual disability and (2) whether arterial stiffness can predict the risk for CVD. METHODS: This cross-sectional study included 58 individuals who participated in wave 4 of the Intellectual Disability Supplement to the Irish Longitudinal Study on Aging (2019-2020). Statistical models were used to address the first aim, whereas machine learning models were used to improve the accuracy of risk predictions in the second aim. RESULTS: Sample characteristics were mean (SD) age of 60.69 (10.48) years, women (62.1%), mild/moderate level of intellectual disability (91.4%), living in community group homes (53.4%), overweight/obese (84.5%), high cholesterol (46.6%), alcohol consumption (48.3%), hypertension (25.9%), diabetes (17.24%), and smokers (3.4%). Mean (SD) pulse wave velocity (arterial stiffness measured by Mobil-O-Graph) was 8.776 (1.6) m/s. Cardiovascular disease risk categories, calculated using SCORE2, were low-to-moderate risk (44.8%), high risk (46.6%), and very high risk (8.6%). Using proportional odds logistic regression, significant associations were found between arterial stiffness, diabetes diagnosis, and CVD risk SCORE2 (P < .001). We also found the Mobil-O-Graph can predict risk of CVD, with prediction accuracy of the proportional odds logistic regression model approximately 60.12% (SE, 3.2%). Machine learning models, k-nearest neighbor, and random forest improved model predictions over and above proportional odds logistic regression at 75.85% and 77.7%, respectively. CONCLUSIONS: Arterial stiffness, as measured by the noninvasive Mobil-O-Graph, can be used to predict risk of CVD in individuals with intellectual disabilities.

High Levels of Psychological Distress, Sleep Disturbance, and Alcohol Use Disorder in Adults With Atopic Dermatitis.

BACKGROUND: The burden of illness associated with atopic dermatitis (AD) is significant and multidimensional, especially in those with moderate to severe disease. OBJECTIVE: Our objective was to evaluate the disease burden of patients with AD in relation to psychological distress, sleep disturbance, and alcohol misuse. METHODS: Patients with AD, attending 2 tertiary referral centers in Dublin, Ireland, were recruited. A series of validated questionnaires were used including the Patient-Oriented Eczema Measure, Dermatology Life Quality Index (DLQI), Center for Epidemiologic Studies-Depression Scale, Quality of Life in Atopic Dermatitis Questionnaire, Alcohol Use Disorders Identification Test, and Pittsburgh Sleep Quality Index. The Eczema Area and Severity Index was calculated contemporaneously with the questionnaire completion. RESULTS: One hundred patients completed the questionnaire, of whom 52% were female. Sixty-three percent of patients experienced impaired quality of life as measured by the DLQI. Higher DLQI scores correlated with decreasing age (r = 0.3277, P < 0.0009). Thirty percent were found to be at risk of clinical depression, and higher Center for Epidemiologic Studies-Depression Scale scores correlated with a younger age and eczema severity. Sleep disturbance was greater in those at risk of depression (mean = 10.40 vs 5.79, P < 0.0001). Patients with moderate to severe AD were more likely to score higher on the Alcohol Use Disorders Identification Test, and 25% met the criteria for alcohol use disorder. In relation to sleep, 73% of patients scored higher than 5 on the Pittsburgh Sleep Quality Index, which signifies poor sleep quality. CONCLUSIONS: Patients with AD endure a significant burden on health with regard to mental well-being, alcohol use, and sleep quality. Clinicians should consider screening patients for these comorbidities.

Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council.

BACKGROUND: Psoriasis severity categories have been important tools for clinicians to use in treatment decisions as well as to determine eligibility criteria for clinical studies. However, owing to the heterogeneity of severity classifications and their lack of consideration for the impact of psoriasis involvement of special areas or past treatment history, patients may be miscategorized, which can lead to undertreatment of psoriasis. OBJECTIVE: To develop a consensus statement on the classification of psoriasis severity. METHODS: A modified Delphi approach was developed by the International Psoriasis Council to define psoriasis severity. RESULTS: After completion of the exercise, 7 severity definitions were preferentially ranked. This most preferred statement rejects the mild, moderate, and severe categories in favor of a dichotomous definition: Psoriasis patients should be classified as either candidates for topical therapy or candidates for systemic therapy; the latter are patients who meet at least one of the following criteria: (1) body surface area >10%, (2) disease involving special areas, and (3) failure of topical therapy. LIMITATIONS: This effort might have suffered from a lack of representation by all relevant stakeholders, including patients. CONCLUSION: The consensus statement describes 2 categories of psoriasis severity, while accounting for special circumstances where patients may require systemic therapy.

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.

Genital Psoriasis: Impact on Quality of Life and Treatment Options.

Psoriasis involving the genital skin occurs in up to two-thirds of psoriasis patients but is often overlooked by physicians. Furthermore, psoriasis objective and subjective severity indexes for common plaque psoriasis often neglect the impact this small area of psoriasis can have on a patient. It can have a significant impact on patients' psychosocial function due to intrusive physical symptoms such as genital itch and pain, and a detrimental impact on sexual health and impaired relationships. The mainstay of treatment is topical therapy. In patients with genital psoriasis refractory to traditional topical treatment, biologic treatments may greatly improve patient outcomes.

Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial.

BACKGROUND: Psoriasis is an autoimmune disease that affects approximately 100 million people worldwide, and is a disease that can be ameliorated by anti-cytokine treatment. We aimed to compare the efficacy and safety of risankizumab with adalimumab in patients with moderate-to-severe plaque psoriasis. METHODS: IMMvent was a phase 3, randomised, double-blind, active-comparator-controlled trial completed at 66 clinics in 11 countries. Eligible patients were aged 18 years or older with moderate-to-severe chronic plaque psoriasis. Patients were randomly assigned 1:1 using interactive response technology to receive 150 mg risankizumab subcutaneously at weeks 0 and 4 or 80 mg adalimumab subcutaneously at randomisation, then 40 mg at weeks 1, 3, 5, and every other week thereafter during a 16-week double-blind treatment period (part A). For weeks 16-44 (part B), adalimumab intermediate responders were re-randomised 1:1 to continue 40 mg adalimumab or switch to 150 mg risankizumab. In part A, participants and investigators were masked to study treatment. Randomisation was stratified by weight and previous tumour necrosis factor inhibitor exposure. Co-primary endpoints in part A were a 90% improvement from baseline (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 16, and for part B was PASI 90 at week 44 (non-responder imputation). Efficacy analyses were done in the intention-to-treat population and safety analyses were done in the safety population (all patients who received at least one dose of study drug or placebo). This study is registered with ClinicalTrials.gov, number NCT02694523. FINDINGS: Between March 31, 2016, and Aug 24, 2017, 605 patients were randomly assigned to receive either risankizumab (n=301, 50%) or adalimumab (n=304, 50%). 294 (98%) of patients in the risankizumab group and 291 (96%) in the adalimumab group completed part A, and 51 (96%) of 53 patients re-randomised to risankizumab and 51 (91%) of 56 patients re-randomised to continue adalimumab completed part B. At week 16, PASI 90 was achieved in 218 (72%) of 301 patients given risankizumab and 144 (47%) of 304 patients given adalimumab (adjusted absolute difference 24·9% [95% CI 17·5-32·4]; p<0·0001), and sPGA scores of 0 or 1 were achieved in 252 (84%) patients given risankizumab and 252 (60%) patients given adalimumab (adjusted absolute difference 23·3% [16·6-30·1]; p<0·0001). In part B, among adalimumab intermediate responders, PASI 90 was achieved by 35 (66%) of 53 patients switched to risankizumab and 12 (21%) of 56 patients continuing adalimumab (adjusted absolute difference 45·0% [28·9-61·1]; p<0·0001) at week 44. Adverse events were reported in 168 (56%) of 301 patients given risankizumab and 179 (57%) of 304 patients given adalimumab in part A, and among adalimumab intermediate responders, adverse events were reported in 40 (75%) of 53 patients who switched to risankizumab and 37 (66%) of 56 patients who continued adalimumab in part B. INTERPRETATION: Risankizumab showed significantly greater efficacy than adalimumab in providing skin clearance in patients with moderate-to-severe plaque psoriasis. No additional safety concerns were identified for patients who switched from adalimumab to risankizumab. Treatment with risankizumab provides flexibility in the long-term treatment of psoriasis. FUNDING: AbbVie and Boehringer Ingelheim.

Clinical considerations for the management of psoriasis in women.

The burden of psoriasis is particularly high for women, who report lower levels of happiness (women: 18.5%; men: 11.3% lower vs. general population) and are more likely to experience stress (women: > 60%; men: 42%), loneliness (women: 25-28%; men: 19-24%), stigmatization (Feelings of Stigmatization Questionnaire score; women: 93.2; men: 78.0), and reduced sexual activity (women: 33%; men: 19%) compared with men. The onset of psoriasis is bimodal, with one incidence peak (15-30 years) that coincides with the prime reproductive age for women, which poses specific challenges for their treatment. However, well-established guidelines for the treatment of women of childbearing age are lacking. Many women experience stabilization (21%) or improvement (55%) of their skin during pregnancy, but up to a quarter can experience disease worsening, and postpartum flares are common (> 50%). Therefore, balancing the risk of treatment with the risk of uncontrolled disease is important. Because half of pregnancies are unplanned, the implications of therapeutic options must be considered for all women with psoriasis who are sexually active, irrespective of intentions to start a family. Timely initiation of these discussions by health care professionals is paramount to prevent unintentional toxicity to the developing fetus. For example, acitretin, methotrexate, and oral psoralen/ultraviolet A are all contraindicated in pregnancy. Reassuringly, safety data for other psoriasis treatments during pregnancy are increasingly available, particularly for anti-tumor necrosis factor therapies. Despite encouraging data from pregnancy exposure registries and clinical studies now being included in anti-tumor necrosis factor drug labels, comfort with prescribing these therapies to pregnant women remains low (U.S. dermatologists: 21%; EU-5 dermatologists: 10%). In this article, we review issues specific to treating women of childbearing age with psoriasis and highlight the need for treatment guidelines to ensure consistent care and optimal outcomes for these patients.

Clinical Goals and Barriers to Effective Psoriasis Care.

Engaging global key opinion leaders, the International Psoriasis Council (IPC) held a day-long roundtable discussion with the primary purpose to discuss the treatment goals of psoriasis patients and worldwide barriers to optimal care. Setting clear expectations might ultimately encourage undertreated psoriasis patients to seek care in an era in which great gains in therapeutic efficacy have been achieved. Here, we discuss the option for early treatment of all categories of psoriasis to alleviate disease impact while emphasizing the need for more focused attention for psoriasis patients with mild and moderate forms of this autoimmune disease. In addition, we encourage policy changes to keep pace with the innovative therapies and clinical science and highlight the demand for greater understanding of treatment barriers in resource-poor countries.

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.

Dietary Recommendations for Adults With Psoriasis or Psoriatic Arthritis From the Medical Board of the National Psoriasis Foundation: A Systematic Review.

Importance: Psoriasis is a chronic, inflammatory skin disease and has significant associated morbidity and effect on quality of life. It is important to determine whether dietary interventions help reduce disease severity in patients with psoriatic diseases. Objective: To make evidence-based dietary recommendations for adults with psoriasis and/or psoriatic arthritis from the Medical Board of the National Psoriasis Foundation. Evidence Review: We used literature from prior systematic reviews as well as additional primary literature from the MEDLINE database from January 1, 2014, to August 31, 2017, that evaluated the impact of diet on psoriasis. We included observational and interventional studies of patients with psoriasis or psoriatic arthritis. The quality of included studies was assessed using the Newcastle-Ottawa scale for observational studies and the Cochrane Risk of Bias Tool for interventional studies. We made evidence-based dietary recommendations, which were voted on by the National Psoriasis Foundation Medical Board. Findings: We identified 55 studies meeting the inclusion criteria for this review. These studies represent 77 557 unique participants of which 4534 have psoriasis. Based on the literature, we strongly recommend dietary weight reduction with a hypocaloric diet in overweight and obese patients with psoriasis. We weakly recommend a gluten-free diet only in patients who test positive for serologic markers of gluten sensitivity. Based on low-quality data, select foods, nutrients, and dietary patterns may affect psoriasis. For patients with psoriatic arthritis, we weakly recommend vitamin D supplementation and dietary weight reduction with a hypocaloric diet in overweight and obese patients. Dietary interventions should always be used in conjunction with standard medical therapies for psoriasis and psoriatic arthritis. Conclusions and Relevance: Adults with psoriasis and/or psoriatic arthritis can supplement their standard medical therapies with dietary interventions to reduce disease severity. These dietary recommendations from the National Psoriasis Foundation Medical Board will help guide clinicians regarding the utility of dietary interventions in adults with psoriatic diseases.

Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis.

BACKGROUND: Adalimumab is approved for the treatment of hidradenitis suppurativa (HS), plaque psoriasis, and other inflammatory conditions. OBJECTIVE: Our objective was to examine the safety of adalimumab administered every other week (EOW) and every week (EW) in patients with HS and psoriasis and to investigate informative data from non-dermatologic indications. METHODS: The safety of adalimumab 40-mg EOW versus EW dosing was examined during placebo-controlled and open-label study periods in patients with HS (three studies), psoriasis (two studies), Crohn's disease (six studies), ulcerative colitis (three studies), and rheumatoid arthritis (one study). RESULTS: No new safety risks or increased rates of particular adverse events (AEs) were identified with EW dosing. In patients with HS or psoriasis, the overall safety of adalimumab 40-mg EOW and EW was generally comparable. In studies of adalimumab for non-dermatologic indications, including Crohn's disease, ulcerative colitis, and rheumatoid arthritis, the overall AE rates were similar for EW and EOW dosing. CONCLUSION: In patients with HS or psoriasis, the safety of adalimumab EW and EOW was comparable and consistent with the expected adalimumab AE profile. The safety of adalimumab EW dosing in patients with dermatologic conditions is supported by data comparing adalimumab EW and EOW dosing for Crohn's disease, ulcerative colitis, and rheumatoid arthritis. TRIAL REGISTRATION: ClinicalTrials.gov NCT00918255, NCT01468207, NCT01468233, NCT00645814, NCT00077779, NCT00055497, NCT01070303, NCT00195715, NCT00348283, NCT00385736, NCT00408629, and NCT00573794.

Management of psoriasis in patients with inflammatory bowel disease: From the Medical Board of the National Psoriasis Foundation.

BACKGROUND: There is a significant association between psoriasis and inflammatory bowel disease (IBD). Many treatments for psoriasis and psoriatic arthritis are also used for IBD. OBJECTIVE: To assess therapeutic options for patients with psoriasis and concurrent IBD. METHODS: A systematic literature search was performed for clinical studies of biologic and systemic psoriasis medications in psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease, for the period from January 1, 1947, to February 14, 2017. Randomized, controlled, double-blinded studies were selected if available. If not, the next highest level of available evidence was selected. RESULTS: Of the 2282 articles identified, 132 were selected. Infliximab and adalimumab have demonstrated efficacy in psoriasis, psoriatic arthritis, ulcerative; colitis, and Crohn's disease. Ustekinumab has demonstrated efficacy in psoriasis, psoriatic arthritis, and Crohn's disease. Certolizumab has demonstrated efficacy in psoriatic arthritis and Crohn's disease. Etanercept, secukinumab, brodalumab, and ixekizumab have demonstrated efficacy in psoriasis and psoriatic arthritis but may exacerbate or induce IBD. Guselkumab has demonstrated efficacy in psoriasis. LIMITATIONS: There are no known clinical trials of treatment specifically for concurrent psoriasis and IBD. CONCLUSIONS: Infliximab and adalimumab have demonstrated efficacy in psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease; other agents have demonstrated efficacy for some, but not all, of these indications.

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.

The Development of the Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) to Assess the Impact of Genital Psoriasis on Sexual Health.

INTRODUCTION: Patient-reported outcome measures (PROs) exist for psoriasis but not genital psoriasis (GenPs). METHODS: This cross-sectional, qualitative study in patients with moderate-to-severe GenPs was conducted to support development of a PRO for measuring the impact of GenPs on sexual activity and to establish content validity. The impacts of GenPs were identified in a literature review. Findings from the literature review were discussed with clinicians, and then patients with GenPs were interviewed. RESULTS: From the literature review, 52 articles, 44 abstracts, and 41 clinical trials met predefined search criteria. Of these, 11 concepts emerged as having theoretical support for use as measurable impacts of psoriasis symptoms on patients; these concepts included sexual functioning and general health-related quality of life (HRQoL). These concepts were confirmed and expanded upon by two clinicians who routinely care for patients with GenPs. Interviews were then conducted with GenPs patients (n = 20) to discuss the impact of GenPs on their HRQoL. Eighty percent of patients reported that GenPs impacted sexual frequency. The two-item GenPs Sexual Frequency Questionnaire (GenPs-SFQ) was developed to assess limitations on sexual activity frequency because of GenPs. Cognitive debriefing with an additional 50 patients with GenPs confirmed the utility and understandability of the GenPs-SFQ. CONCLUSION: The GenPs-SFQ may have utility in clinical trials involving GenPs patients and in routine clinical practice. FUNDING: Eli Lilly and Company. Plain language summary available for this article.

Infection-free Clinical Response Among Patients With Hidradenitis Suppurativa Who Were Treated With Adalimumab: Results from Two Phase 3 Studies.

OBJECTIVE: The objective of this study is to assess the rates of infection-free achievement of hidradenitis suppurativa clinical response (HiSCR) using integrated data from 2 phase 3, placebo-controlled trials, PIONEER I and II. MATERIALS AND METHODS: Analyses from the first 12 weeks of both studies were examined. Patients were randomized to receive adalimumab (ADA) or placebo, and they then were assessed in the clinic at weeks 0, 2, 4, 8, and 12. All reports of an adverse or serious adverse event and infection were classified as treatment-emergent adverse events (TEAEs). The HiSCR was evaluated as the primary endpoint; infection-free HiSCR was also evaluated. RESULTS: Treatment-emergent adverse events were observed in 55.4% of the ADA group and 64.4% of the placebo (P < .023). The rates of serious TEAEs and infection-related TEAEs were slightly less in the ADA group compared with the placebo group. A significantly higher percentage of ADA-treated patients achieved HiSCR at week 12 compared with placebo (P < .001). At each visit during the study's 12 weeks, a greater proportion of ADA-treated patients achieved infection-free HiSCR compared with patients treated with placebo (P < .001). Mean durations of HiSCR and infection-free HiSCR were significantly longer in ADA-treated patients when compared with placebo-treated patients (P < .001). CONCLUSIONS: Results of this integrated analysis indicate that patients with hidradenitis suppurativa who received a short duration of ADA treatment experienced better combined efficacy and similar safety compared with placebo. Further studies investigating longer ADA treatment may demonstrate further improvements in duration of infection-free clinical response.

Patients' Perspectives on the Impact of Genital Psoriasis: A Qualitative Study.

INTRODUCTION: Plaque psoriasis is a chronic skin disease where genital involvement is relatively common. Yet health care providers do not routinely evaluate psoriasis patients for genital involvement and patients do not readily initiate discussion of it. METHODS: A qualitative study of 20 US patients with dermatologist-confirmed genital psoriasis (GenPs) and self-reported moderate-to-severe GenPs at screening was conducted to identify key GenPs symptoms and their impacts on health-related quality of life (HRQoL). RESULTS: Patients had a mean age of 45 years, 55% were female, and patients had high rates of current/recent moderate-to-severe overall (65%) and genital (70%) psoriasis. Patients reported the following GenPs symptoms: genital itch (100%), discomfort (100%), redness (95%), stinging/burning (95%), pain (85%), and scaling (75%). Genital itching (40%) and stinging/burning (40%) were the most bothersome symptoms. Impacts on sexual health included impaired sexual experience during sexual activity (80%), worsening of symptoms after sexual activity (80%), decreased frequency of sexual activity (80%), avoidance of sexual relationships (75%), and reduced sexual desire (55%). Negative effects on sexual experience encompassed physical effects such as mechanical friction, cracking, and pain as well as psychosocial effects such as embarrassment and feeling stigmatized. Males reported a higher burden of symptoms and sexual impacts. Other HRQoL impacts were on mood/emotion (95%), physical activities (70%), daily activities (60%), and relationships with friends and family (45%). These impacts significantly affected daily activities. Physical activities were affected by symptoms and flares, and increased sweat and friction worsened symptoms. Patients reported daily practices to control outcomes. CONCLUSION: The high level of reported symptoms and sexual and nonsexual impacts reflects the potential burden of moderate-to-severe GenPs. GenPs can impact many facets of HRQoL and providers should evaluate their patients for the presence of genital psoriasis and its impact on their quality of life. FUNDING: Eli Lilly and Company.

From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis.

BACKGROUND: An urgent need exists in the United States to establish treatment goals in psoriasis. OBJECTIVE: We aim to establish defined treatment targets toward which clinicians and patients with psoriasis can strive to inform treatment decisions, reduce disease burden, and improve outcomes in practice. METHODS: The National Psoriasis Foundation conducted a consensus-building study among psoriasis experts using the Delphi method. The process consisted of: (1) literature review, (2) pre-Delphi question selection and input from general dermatologists and patients, and (3) 4 Delphi rounds. RESULTS: A total of 25 psoriasis experts participated in the Delphi process. The most preferred instrument was body surface area (BSA). The most preferred time for evaluating patient response after starting new therapies was at 3 months. The acceptable response at 3 months postinitiation was either BSA 3% or less or BSA improvement 75% or more from baseline. The target response at 3 months postinitiation was BSA 1% or less. During the maintenance period, evaluation every 6 months was most preferred. The target response at every 6 months maintenance evaluation is BSA 1% or less. LIMITATIONS: Although BSA is feasible in practice, it does not encompass health-related quality of life, costs, and risks of side effects. CONCLUSION: With defined treatment targets, clinicians and patients can regularly evaluate treatment responses and perform benefit-risk assessments of therapeutic options individualized to the patient.

Psoriasis and cardiovascular disorders.

Psoriasis is associated with an increased risk of cardiovascular disease and related comorbidities such as diabetes mellitus, metabolic syndrome, dyslipidemia, and obesity. The precise mechanistic links underlying the association between psoriasis and cardiovascular disease remain unknown, however, multiple pathologic mechanisms have been proposed. Shared inflammatory pathways between psoriasis and atherosclerosis are likely involved. Other possible mechanisms include endothelial dysfunction, cytokine dysregulation, platelet upregulation, and dyslipidemia. Additional studies are needed to more clearly define the association between psoriasis and cardiovascular disease. Current, but limited, data suggests that psoriasis treatments targeting inflammation may be able to reduce the cardiovascular risks in this patient population. As new therapies become available, long-term prospective studies will be required to determine their potential effects on cardiovascular risk. This review summarizes the current literature on proposed pathogenic links between psoriasis and cardiovascular disease, the epidemiology of psoriasis and associated cardiovascular and cardiometabolic diseases, and the impact of anti-psoriatic treatments on cardiovascular risk profile. In addition, we provide a brief discussion of risk factor management strategies in patients with psoriasis.