Patients Perspective on the Impact of Moderate-to-Severe Genital Psoriasis

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1 4664 Patients Perspective on the Impact of Moderate-to-Severe Genital Psoriasis Jennifer Clay Cather, 1 Alison Potts Bleakman, 2 April Naegeli, 2 Jiat Ling Poon, 3 Ashley Wallace, 4 Kristin Hollister, 2 Scott Fretzin 4 1 Modern Dermatology, Dallas, USA; 2 Eli Lilly and Company, Indianapolis, USA; 3 Evidera, Bethesda, USA; 4 Dawes & Fretzin Dermatology Group, Indianapolis, USA This study was sponsored by Eli Lilly and Company.

2 Disclosures J. Cather is in the speaker bureau of: AbbVie, Allergan, Celgene, Janssen, received honoraria from: AbbVie, Eli Lilly and Company, Janssen, Novartis, is a consultant for: AbbVie, Eli Lilly and Company, Janssen, Novartis, is an investigator for: Allergan, Celgene, Cutanea, Dermira, Galderma Labs, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, Tolmar Pharma, Vitae, Xenoport, has received grants from: Allergan, Celgene, Cutanea, Dermira, GlaxoSmithKline, Galderma Labs, Janssen, MSD, Novartis, Pfizer, Regeneron, Sandoz, Tolmar Pharma, Vitae, Xenoport, has received other financial benefit from: AbbVie This study was sponsored by Eli Lilly and Company. Medical writing services were provided by Samantha Forster, PhD of ProScribe part of the Envision Pharma Group, and were funded by Eli Lilly and Company

3 Background and Objective Background Surveys of patients with psoriasis suggest that genital involvement occurs in 29%-63% of the population at some point in the course of the disease 1,2 Data from studies that involve physical examination show that 38% of patients have current genital psoriasis involvement 2,3 Patients with genital psoriasis experience greater impairment in health-related quality of life (HRQoL) and sexual health than patients without genital lesions 2,4 Fewer than 50% of patients with genital psoriasis discuss their symptoms with their physician 5 Better understanding of the impact of genital psoriasis is required to improve the treatment and HRQoL of patients Objective To assess the impact of moderate-to-severe genital psoriasis on sexual health and HRQoL 1. Meeuwis KA, et al. Acta Dermatol Venereol. 2011;91: Ryan C, et al. J Am Acad Dermatol. 2015;72: Ji S, et al. Int J Impot Res. 2016;28: Meeuwis KA, et al. Br J Dermatol. 2011;164: Meeuwis KA, et al. Dermatology. 2012;224;

4 Patients and Methods Inclusion Criteria Aged 18 years Physician-diagnosed chronic plaque psoriasis of duration 6 months Involvement of 1% body surface area Past or current genital psoriasis confirmed by dermatologist and self-reported current or recent ( 3 months) moderate-to-severe genital psoriasis (per Patient Global Assessment 4) Response failure or intolerance of 1 topical therapy used for the treatment of genital psoriasis In-depth Patient Interviews One-on-one, semi-structured interviews conducted with patients from 5 US-based clinics Interviews were designed based on literature reviews and clinicians clinical experience of symptom concepts of genital psoriasis that are of greatest clinical relevance to patients Intended to elicit information about genital psoriasis symptoms and their impact on sexual function and HRQoL Patients were given a choice between an in-person interview and a telephone interview Transcripts were coded and analyzed to identify key themes and responses using ATLAS.ti 7.5.9

5 Baseline Demographics and Characteristics Patients (N=20) Age, years 45 (14.2) Sex, n (%) Male 9 (45) Race, n (%) White Other Duration of disease, a years Psoriasis Genital psoriasis Current moderate-to-severe, b n (%) Psoriasis Genital psoriasis a From diagnosis b Self-reported severity of symptoms. Values are mean (standard deviation) unless otherwise stated 18 (90) 2 (5) 18 (14.0) 7.5 (9.7) 18 (90) 19 (95) All patients indicated preference for a telephone interview

6 Impact of Genital Psoriasis on Sexual Activity and Sexual Satisfaction, N=20 Sexual Activity Status a Sexual Satisfaction 10% 45% Active 20% 25% Negatively impacted: Very much 45% Not Active Declined to Answer 30% 25% Quite a bit Not at all Other b a Sexual activity was defined to the patient as not limited to sexual intercourse and inclusive of activities such as masturbation. Interviewer phraseology may have varied b Other includes: Somewhat (10%), A little bit (5%), and Have not had genital psoriasis symptoms in the past week (5%) An equal proportion of patients (45%) reported sexual activity and inactivity Genital psoriasis affected sexual satisfaction either very much or quite a bit in 50% of patients

7 Impact of Genital Psoriasis on Sexual Health Symptom Worsening a Impaired Sexual Experience Reduced Sexual Frequency N=20 patients Impact Reported 80% 80% 80% Avoidance of Sexual Relationships 75% Reduced Sexual Desire 55% Symptom Reported Spontaneous vs. Probed b 60% 65% 35% 60% 10% 20% 15% 45% 15% 45% a Worsening of genital psoriasis symptoms after sexual activity. The presence/absence of each impact was assessed independently of symptom worsening b The interviewer asked probing questions to obtain information regarding specific impacts if not spontaneously mentioned Individual sexual impacts were reported by the majority of patients interviewed Most (90%) spontaneously reported 1 impact of genital psoriasis on sexual health

8 Representative Patient Quotes: Impacts on Sexual Health if there s patches on the penis itself and you get a full erection, then the skin can tear, so you have to limit [sexual activity] to when that s not the case So sometimes you make a calculated decision as to how badly do I want to engage in this activity given what the cost is going to be and pain and discomfort post activity for hours and/or days if his stuff gets on there, it sets it [my skin] on fire, so you just have to immediately sit in another Epsom salt bath it s just like three days of hell, so it s not worth it to me it s taken it [sexual desire] away just because it s just too painful I told him if it comes between having sex because it s so painful and not being married, then I choose not to be married Selected quotes are from different patients and have been edited to minimize repetitive language

9 Impact of Genital Psoriasis on HRQoL N=20 patients Impact Reported Negative Impact on: Symptom Reported Spontaneously vs. Probed a Mood/Emotion Physical Activities Daily Activities 95% 70% 60% Social/Leisure Activities 45% Relationships with Friends & Family 45% Work/School 35% 25% 10% 10% 10% 20% 5% 70% 60% 50% 35% 25% 30% a The interviewer asked probing questions to obtain information regarding specific impacts if not spontaneously mentioned The majority of patients expressed HRQoL impacts on mood/emotion (95%), physical activities (70%), and daily activities (60%) Patients were more likely to report impacts on HRQoL after probing, rather than spontaneously

10 Representative Patient Quotes: Impacts on HRQoL it s affected my life in so many ways What I can wear, what activities I can involve myself in I don t really like to do a whole lot because I am feeling discomfort with the stress, and a lack of confidence whether it be with my partner or just in every day life I m not social any more. I don t get out much. I ve become a recluse if it starts itching or something, it s not seemly that you would, be able to take care of yourself in a public situation running and jogging is something I really I ve had to take [time] off work because I just couldn t stand it even your pants that you don t think are tight are still tight enjoy when that process of cracking and the skin is peeling off you can t jog or run Selected quotes are from different patients and have been edited to minimize repetitive language

11 Conclusions Nearly all patients reported at least one negative impact on sexual aspects of their quality of life Genital psoriasis was reported to negatively impact patients general well-being, affecting personal relationships and physical, social, and daily activities Patients spontaneously reported sexual health impacts more frequently than they reported general HRQoL impacts Dermatologists are encouraged to discuss the impact of genital psoriasis with patients, as they may disclose more information when asked

12 Supplementary Information

13 Interview Guide: Sexual Health 1. Are you sexually active? 2. Have your genital psoriasis symptoms affected your sexual life? a a. How do your genital psoriasis symptoms affect your sexual desire? b. How do your genital psoriasis symptoms physically affect your sexual experience? I. How do genital psoriasis symptoms affect your sexual frequency? II. Do your genital psoriasis symptoms worsen during/following intercourse? a III. Does your genital psoriasis cause you to avoid having sexual relationships? If so, why? Do you avoid sexual relationships due to the: Appearance of your genital psoriasis symptoms? Pain experienced during intercourse? Discomfort experienced during intercourse? Worsening of your genital psoriasis symptoms during intercourse? Way your genital psoriasis makes you feel? a Questions followed by If so, in what way(s)?

14 Interview Guide: Overall HRQoL Impact 1. How have your genital psoriasis symptoms affected your life in general? Note: Spontaneously reported symptoms were noted first without any probing 2. Which of these symptoms affects your life the most? How? 3. Have your genital psoriasis symptoms affected your physical activities? a 4. Have your genital psoriasis symptoms affected your mood or emotional status? a 5. Have your genital psoriasis symptoms affected your social or leisure activities? a 6. Have your genital psoriasis symptoms affected your work (or school)? a 7. Have your genital psoriasis symptoms affected your daily activities? a 8. Have your relationships with friends or family been affected? a a Questions followed by If so, in what way(s)?

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