Dataset Information

Baseline patient-reported outcomes from UNITE: an observational, international, multicentre registry to evaluate hidradenitis suppurativa in clinical practice.

ABSTRACT:

Background

Hidradenitis suppurativa (HS) is a chronic, inflammatory, skin condition associated with many comorbidities and often has a substantial impact on patients' lives.

Objectives

To evaluate symptom burden and health-related quality of life (HRQoL) at baseline in patients with HS in an observational, real-world, clinical setting using several tools including a validated HS-specific instrument.

Methods

This study evaluated HRQoL data from the international UNITE HS disease registry. Administration of patient-reported outcome (PRO) instruments and collection of data were executed per local regulations. All data were assessed using descriptive statistical methods.

Results

PRO data from 529 adults and 65 adolescents were evaluated. Most adults (64.5%) and adolescents (73.8%) were classified as Hurley Stage II with substantial disease burden at baseline. HS had a large effect (mean DLQI = 12.6) and moderate effect (mean CDLQI = 6.9) on the lives of adults and adolescents, respectively. Approximately 58% of adults and 41% of adolescents had anxiety scores beyond the normal range; 30% of adults and 16% of adolescents exhibited symptoms of depression. Based on HSSA and HSIA scores, approximately 30% of adults reported a substantial burden of multiple HS clinical symptoms and more than 45% reported a significant emotional impact of HS that adversely affected their intimate relationships. Only 60% of adults were employed and of those, 64% reported at least some degree of impairment while working because of HS.

Conclusions

Based on PROs collected from patients enrolled in the UNITE registry, a real-world, clinical setting, HS has a significant negative impact on the everyday lives of patients affected by this disease.

SUBMITTER: Kimball AB

PROVIDER: S-EPMC7317945 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Baseline patient-reported outcomes from UNITE: an observational, international, multicentre registry to evaluate hidradenitis suppurativa in clinical practice.

Kimball A B AB Crowley J J JJ Papp K K Calimlim B B Duan Y Y Fleischer A B AB Sobell J J

Journal of the European Academy of Dermatology and Venereology : JEADV 20200301 6

<h4>Background</h4>Hidradenitis suppurativa (HS) is a chronic, inflammatory, skin condition associated with many comorbidities and often has a substantial impact on patients' lives.<h4>Objectives</h4>To evaluate symptom burden and health-related quality of life (HRQoL) at baseline in patients with HS in an observational, real-world, clinical setting using several tools including a validated HS-specific instrument.<h4>Methods</h4>This study evaluated HRQoL data from the international UNITE HS dis ...[more]

PMID: 31800124

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Project description:IntroductionHidradenitis suppurativa (HS) is considered to be the most burdensome dermatosis, with a well-documented negative influence on quality of life (QoL). The patient's perception of the disorder, assessed as the self-reported severity, has been used in other dermatoses but not in HS. The aim of this study was to evaluate the usefulness of self-reported HS severity in clinical practice.MethodsThe study was performed on a group of 130 Spanish HS patients. HS severity was assessed for all the subjects. Hurley staging and patient self-reported severity were used. Moreover, QoL impairment was evaluated using the Dermatology Life Quality Index (DLQI) and the Hidradenitis Suppurativa Quality of Life 24 (HSQoL-24) questionnaire.ResultsThe severity of HS according to the Hurley staging was most commonly assessed as Hurley II (47.7%), indicating moderate disease, followed by severe disease (Hurley III, 26.9%) and mild disease (Hurley I, 25.4%). According to the patient self-reported HS severity, most of the patients reported having mild disease (76 patients, 58.5%), followed by moderate disease (31 patients, 23.8%). Only 23 patients (17.7%) assessed their disease as severe. Moreover, men reported mild disease significantly more frequently than women (70.9% and 49.3%, respectively; p = 0.014). The self-reported HS severity correlated positively with the effect of the disease on patient QoL assessed with DLQI (r = 0.288, p < 0.001). Likewise, a strong positive correlation was found between self-reported HS severity and QoL impairment assessed with HSQoL-24 (r = 0.404, p = 0.001). No statistically significant correlation between Hurley severity stage and DLQI or HSQoL-24 was found. Moreover, there were significant differences in both DLQI and HSQoL-24 total score between different self-reported HS severities. This was not seen for any of the QoL instruments or for Hurley severity staging.ConclusionThe results show that self-assessment severity may reflect patients' subjective feelings more adequately than popular objective instruments, and there should be a place for its use in daily clinical practice.

Project description:IntroductionManagement of hidradenitis suppurativa (HS) often requires a combined medical/procedural approach. Biologics are frequently reserved for severe cases after irreversible tissue damage has occurred. We evaluated the association between consistent biologic use and the need for procedural interventions, systemic medications, and healthcare utilization.MethodsUNITE, a 4-year, global, prospective, observational, HS disease registry, documented the natural history, diagnostic/treatment patterns, and clinical outcomes of HS. Patients aged 12 years or more, with active HS were enrolled between October 2013 and December 2015 and evaluated every 6 months for 48 months at 73 sites across 12 countries (data cutoff December 2019). Proportions of patients requiring different HS procedures, systemic medications, and healthcare utilization were assessed during the 6-month periods before, during, and after biologic initiation for 12 weeks or more (i.e., consistent use).ResultsThere were 63 instances of initiation of consistent biologic use (adalimumab [81%], infliximab [16%], and ustekinumab [3%]) in 57 patients. Patients' mean age was 40 years, 58% were female, and 53%/47% had Hurley stage II/III disease, respectively. Fewer patients required surgical/procedural interventions and systemic medications for the 6-month period during/6-month period after biologic initiation versus the 6-month period before biologic initiation, including intralesional corticosteroid injections (22%/14% vs 24%), incision and drainage (I&D) by physician (10%/10% vs 17%), I&D by patient (10%/10% vs 14%), surgical excision (8%/10% vs 11%), deroofing (5%/2% vs 5%), systemic antibiotics (43%/41% vs 54%), and systemic immunosuppressants (10%/6% vs 13%). Fewer patients required hospital admission for HS (17%/13% vs 21%) or emergency department visits for HS (8%/8% vs 16%) during the 6-month periods in which consistent biologics use started and continued versus the 6-month period before consistent biologic use.ConclusionFollowing initiation of consistent biologic use (12 weeks or more), fewer patients required acute procedural interventions, systemic medications, and healthcare utilization, supporting the importance of early biologic initiation.

Project description:IntroductionHidradenitis 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.MethodsData 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.ResultsFifty-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.ConclusionsAll 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.

Dataset Information

Baseline patient-reported outcomes from UNITE: an observational, international, multicentre registry to evaluate hidradenitis suppurativa in clinical practice.

Background

Objectives

Methods

Results

Conclusions

Publications

Baseline patient-reported outcomes from UNITE: an observational, international, multicentre registry to evaluate hidradenitis suppurativa in clinical practice.

Similar Datasets

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