Burden of Hidradenitis Suppurativa: A Systematic Literature Review of Patient Reported Outcomes.

INTRODUCTION: Hidradenitis suppurativa (HS) has a profound negative impact on patients' health-related quality of life (HRQoL). Here we summarize the evidence on HRQoL and Patient Reported Outcomes (PROs) in patients with HS in real-world settings by conducting a systematic literature review (SLR) of observational studies. METHODS: Data sources included MEDLINE, Embase & PsycINFO between January 1, 2010 and August 29, 2021, and conference proceedings between 2019 and 2021. Identified abstracts were reviewed and screened independently by two reviewers. Eligibility criteria included patients with HS of any severity, sample size ≥ 100, reporting PROs including HRQoL measures. Included studies were critically appraised. RESULTS: Fifty-eight observational studies matched inclusion criteria. Dermatology Life Quality Index (DLQI) was the most commonly utilized instrument: 57% of included studies reported mean baseline DLQI scores, ranging between 8.4 and 16.9, indicating a very large impact on the patients' HRQoL. Higher scores were reported with increasing disease severity and among female patients. Pain was assessed mostly by an 11-point (0-10) numeric rating scale (NRS) with a mean baseline score ranging from 3.6 to 7.7 indicating moderate to high pain levels. There was a negative impact of HS on patients' psychological well-being, based on PRO scores related to depression and anxiety. A high proportion of sexual dysfunction was reported, with a larger impact on women than men. Work productivity and leisure activity were consistently found to be impaired in patients with HS. CONCLUSIONS: All included studies reported a negative impact of HS on patients' lives. A diverse set of disease- and non-disease-specific PRO instruments were utilized highlighting the need for more consistent use of HS-specific validated PRO instruments to assess the impact of HS on the different aspects of patients' HRQoL to allow for data to be more meaningfully interpreted and compared in real-world settings. Patients with HS need better disease management approaches that address the observed low quality of life.

Hidradenitis suppurativa (HS) is a skin disease, which mainly involves the hair follicles, and may greatly affect the health of those with the illness. HS often causes painful or itchy bumps or swelling of the skin, especially in the intimate areas. These occasionally drain and have an odor. When they heal, sometimes they leave dark spots or scars. People with HS can feel depressed, anxious, or embarrassed, among other things. In this study, we looked at how existing studies measured the impact of HS on the physical, mental, and social quality of people's lives. When searching the Internet, we found 58 publications on studies around this topic. Across all of the studies, HS had a large negative effect on patients' quality of life. We found that the groups of people which were impacted more by HS had worse cases of the disease. Patients with more severe HS felt higher levels of pain. Women were also affected more than men. Many studies showed that patients with HS often felt depressed and anxious. Three studies showed that HS greatly affected women's sexual health. Many patients said that HS made it hard to work and do things for fun. More and better treatments are needed since HS can have such a big impact on people's lives.

Electronic Patient-Reported Outcomes in Hidradenitis Suppurativa: Content Validity and Usability of the Electronic Hidradenitis Suppurativa Symptom Daily Diary, Hidradenitis Suppurativa Symptom Questionnaire, and Hidradenitis Suppurativa Quality of Life Questionnaire.

BACKGROUND: Hidradenitis suppurativa (HS), a chronic skin condition that causes pain and physical dysfunction, can impact significantly on quality of life. Disease-specific tools have been designed to assess the impact of HS on patients, including the HS Symptom Daily Diary (HSSDD), the HS Symptom Questionnaire (HSSQ), and the HS Quality of Life (HiSQOL©) questionnaire, which have been developed into electronic instruments (eHSSDD, eHSSQ, and eHiSQOL©). OBJECTIVES: The objective of this study was to establish the content validity of the electronic version of the HSSDD and HSSQ, and the acceptability and usability of the HSSDD, HSSQ, and HiSQOL©, using concept elicitation and cognitive debriefing interviews. METHODS: This was a non-interventional qualitative video interview study involving participants aged ≥18 years with moderate to severe HS recruited from a single clinical site in the USA. Interviews gathered feedback on participants' symptom experience, followed by training and completion of the eHSSDD, eHSSQ, and eHiSQOL© questionnaires on electronic handheld devices. Participants were then interviewed on the content of the eHSSDD and eHSSQ and the acceptability and usability of all three instruments. Interviews were transcribed and qualitatively analysed. RESULTS: Twenty participants with moderate to severe HS (median age: 41.5 [range: 20.0-64.0]; n = 16/20 female) were included. All participants found the eHSSDD, eHSSQ, and eHiSQOL© instructions clear and described the instruments as "easy", "simple" and "self-explanatory". Overall understanding of individual items within the eHSSDD and eHSSQ was high; however, 6/20 participants had difficulty in understanding the average skin pain item in the eHSSDD. All participants were able to accurately recall their symptoms within the recall periods of the eHSSDD and eHSSQ, although 4/20 participants found the 24-h recall period of the eHSSDD limiting. Completion time was quick across all instruments, and usability was high, with the majority of participants reporting no difficulty in completing questionnaires on electronic devices. CONCLUSION: The concepts covered in the eHSSDD and eHSSQ are relevant and important to patients, supporting their content validity. The findings also provide evidence of acceptability and usability of the eHSSDD, eHSSQ, and eHiSQOL©. A limitation was that all participants were recruited from a single site, which may have introduced selection bias and thus limited the generalisability of results.

Real-World Findings on the Characteristics and Treatment Exposures of Patients with Hidradenitis Suppurativa from US Claims Data.

INTRODUCTION: Hidradenitis suppurativa (HS) is a chronic, debilitating, and painful inflammatory skin disease that significantly and negatively impacts patients' quality of life. The prevalence of HS in the USA is estimated to be 0.10%, with worldwide reports suggesting a prevalence closer to 1%. There is limited real-world evidence available on the care of patients with HS. We aimed to evaluate the trends in clinical care and treatment in the patient population with HS in the USA in a real-world setting. METHODS: A cohort study was conducted using claims data from IBM MarketScan Databases, including the US Commercial Claims and Encounters with Medicare Supplemental and Coordination of Benefits (CCAE+MDCR) database and IBM US Medicaid database. RESULTS: The annual prevalence of HS increased from 0.06% (2008) to 0.14% (2017), and from 0.17% (2008) to 0.31% (2017) among CCAE+MDCR and Medicaid patients, respectively. Dermatologist visits increased from 31.9% (2008) to 47.8% (2019) in CCAE+MDCR patients, and decreased from 10.9% (2008) to 8.5% (2018) in Medicaid patients. Opioid use decreased from 45.4% (2008) to 25.5% (2019) among CCAE+MDCR patients, and from 71.3% (2008) to 48.1% (2018) among Medicaid patients. Only 8.4% of CCAE+MDCR patients and 5.8% of Medicaid patients were exposed to any biologic in 2018. CONCLUSIONS: Improved care and treatment of HS over the last decade, including the emergence of new treatments, have been accompanied by an increase in awareness and reported prevalence of the disease. However, there are still gaps in access to dermatologic care and low utilization of biologic therapies among patients with HS. INFOGRAPHIC.

Improvements in productivity and increased participation in daily activities over 52 weeks of certolizumab pegol treatment of rheumatoid arthritis: results of a Belgian observational study.

Objectives: To report changes in productivity and social participation - alongside clinical and patient-reported outcomes (PROs) - in patients with rheumatoid arthritis (RA) receiving certolizumab pegol (CZP) during routine clinical practice in Belgium. Methods: This was a prospective, non-interventional study, in which patients were prescribed CZP at their physicians' discretion and followed during routine clinical visits. The primary outcomes were household productivity and social participation at the last visit (~52 weeks), measured through responses to the Work Productivity Survey. Secondary outcomes included workplace productivity and achievement of DAS28(ESR) clinical response, low disease activity and remission at the last visit. Baseline demographics and adverse events (AEs) were recorded for all patients who received ≥1 dose CZP. Results: A total of 141 patients were enrolled in the study, of whom 119 (84.4%) formed the full analysis set (received ≥1 dose CZP and had ≥1 post-baseline measurement for ≥1 primary outcome). At Visit 1 (baseline), patients reported an average of 11.0 paid work days, 16.8 household work days and 5.5 days of social participation affected by their disease over the previous month. Rapid improvements in household productivity and social participation were evident from Visit 2 (2-8 weeks). By the final visit, mean improvements were observed for all aspects of productivity, participation and clinical/PROs. A total of 24 AEs were reported. Conclusion: CZP has a positive impact on productivity and social participation in patients with RA in the Belgian daily practice setting, with safety and efficacy profiles that mirror those observed in the trial setting.