Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of a phase 3 open-label extension study

Zouboulis, Christos C.; Okun, Martin; Prens, Errol P.; Gniadecki, Robert; Foley, Peter; Lynde, Charles; Weisman, Jamie; Gu, Yihua; Williams, David A.; Jemec, Gregor B. E.

doi:10.1016/j.jaad.2018.05.040

Cited by 142 publications

(187 citation statements)

References 19 publications

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“…Recommendations for treatment strategy based on HS severity and HRQoL changes, as is now standard in psoriasis, may be beneficial. This approach was already taken concerning long‐term adalimumab efficacy in HS patients …”

Section: Discussionmentioning

confidence: 99%

Quality of life measurement in hidradenitis suppurativa: position statement of the European Academy of Dermatology and Venereology task forces on Quality of Life and Patient‐Oriented Outcomes and Acne, Rosacea and Hidradenitis Suppurativa

Chernyshov

Zouboulis

Tómas-Aragonés

et al. 2019

Acad Dermatol Venereol

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This paper is organized jointly by the European Academy of Dermatology and Venereology (EADV) Task Force (TF) on Quality of Life (QoL) and Patient‐Oriented Outcomes and the EADV TF on acne, rosacea and hidradenitis suppurativa (ARHS). The purpose of this paper was to present current knowledge about QoL assessment in HS, including data on HS‐specific health‐related (HR) QoL instruments and HRQoL changes in clinical trials, and to make practical recommendations concerning the assessment of QoL in people with HS. HS results in significant quimp that is higher than in most other chronic skin diseases. HS impact in published studies was assessed predominantly (84% of studies) by the Dermatology Life Quality Index (DLQI). There is a lack of high‐quality clinical trials in HS patients where HRQoL instruments have been used as outcome measures. One double‐blind randomized placebo‐controlled trial on infliximab with low number of participants reported significantly better HRQoL improvement in the treatment group than in the placebo group. Well‐designed clinical studies in HS patients to compare different treatment methods, including surgical methods and assessing long‐term effects, are needed. Because of lack of sufficient validation, the Task Forces are not at present able to recommend existing HS‐specific HRQoL instruments for use in clinical studies. The EADV TFs recommend the dermatology‐specific DLQI questionnaire for use in HS patients. The EADV TFs encourage the further development, validation and use of other HS‐specific, dermatology‐specific and generic instruments but such use should be based on the principles presented in the previous publications of the EADV TF on QoL and Patient‐Oriented Outcomes.

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Section: Discussionmentioning

confidence: 99%

Quality of life measurement in hidradenitis suppurativa: position statement of the European Academy of Dermatology and Venereology task forces on Quality of Life and Patient‐Oriented Outcomes and Acne, Rosacea and Hidradenitis Suppurativa

Chernyshov

Zouboulis

Tómas-Aragonés

et al. 2019

Acad Dermatol Venereol

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“…Previous studies found conflicting results about the relationship between HS and serious infections. Multiple phase III and open‐label clinical trials of adalimumab treatment of HS did not find any increased infection risk . However, these studies excluded any patients with a history of infection requiring intravenous anti‐infectives within 30 days of baseline or oral anti‐infectives within 14 days of baseline; any other active skin disease or condition (e.g.…”

Section: Discussionmentioning

confidence: 99%

Associations of cutaneous and extracutaneous infections with hidradenitis suppurativa in U.S. children and adults

et al. 2019

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Summary Background Hidradenitis suppurativa (HS) is associated with bacterial colonization, skin‐barrier disruption, immune dysregulation and treatments that can increase infection risk. Objectives To determine whether HS is associated with cutaneous and extracutaneous infections and related outcomes. Methods Data from the 2002–2012 National Inpatient Sample were analysed, including a 20% sample of U.S. hospitalizations (n = 87 053 155). Results The prevalence (with 95% confidence interval) of infections was higher in adults (34·0%, 33·2–34·7% vs. 23·4%, 23·2–23·6%) and children (31·8%, 28·7–34·9% vs. 12·6% (12·1–13·1%) with vs. without HS. Inpatients with HS had higher prevalences of infections overall (excluding cellulitis and erysipelas) than those with psoriasis, but lower than those with atopic dermatitis. In multivariable logistic regression models adjusting for sociodemographics, HS was associated with 18 of 45 infections examined (adults: 16 of 45; children: six of 45), including acute infections (herpes simplex virus, herpes zoster, necrotizing fasciitis, septicaemia, bone infection, Clostridium difficile, methicillin‐sensitive and methicillin‐resistant Staphylococcus aureus, Streptococcus, Pseudomonas, mycobacterial, fungal, viral), chronic infections (HIV, hepatitis B) and antibiotic‐resistant infections. HS alone was associated with increased infections. Patients with comorbid cancer; HIV; cardiometabolic, autoimmune or mental health diagnoses or acne had even higher odds of infections. Inpatients with HS with vs. without serious infection had increased inpatient mortality (0·71% vs. 0·16%), mean length of stay (7·3 vs. 4·8 days) and cost of care (US$13 578 vs. $9242), with a mean annual excess 41 050 days and $71 622 339 cost of hospitalization. Conclusions Adults and children with HS had increased acute and chronic, cutaneous, extracutaneous and systemic infections, which were associated with increased mortality and cost. What's already known about this topic? Little is known about the risk of infection in patients with hidradenitis suppurativa (HS). What does this study add? Adults and children with HS had increased cutaneous, extracutaneous and systemic infections, at even higher rates than in patients with psoriasis and atopic dermatitis. These infections were associated with increased inpatient mortality and cost. Respond to this article

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“…The latter part of the flare definition presumes that an increase in lesions is detectable and reliable on clinician assessment, which may not be the case, and neglects the possibility that flare is a worsening of existing lesions. No validation studies of flare definitions were identified, and so no information is available on the validity, repeatability or sensitivity to change of any of the described definitions, including those published more recently …”

Section: Discussionmentioning

confidence: 99%

A narrative review of the definition of ‘flare’ in hidradenitis suppurativa

et al. 2019

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Summary Background Hidradenitis suppurativa (HS) is a chronic, inflammatory condition that can have periodic worsening or flares. Measurement of flare is important because it can inform treatment efficacy; however, it is unclear how HS flare should be defined. Objectives This study reviewed the literature for definitions of HS flare. Methods The PubMed MEDLINE online database was searched on 10 January 2018 and the search was repeated on 8 December 2018 for new publications. Titles and abstracts were screened for inclusion. Subsequently, full articles were screened for inclusion. Papers were included if the publication was a systematic review, clinical trial, cohort study, case report or series, or cross‐sectional study. Studies were excluded if they were journalistic reviews, did not discuss clinical findings of HS or did not use the words ‘flare’, ‘exacerbation’, ‘relapse’ or ‘recurrence’. Results Two hundred and seventy‐four papers were identified and 154 fulfilled the study criteria. Of these, 27 (17.5%) included the term ‘flare’ and 16 (10.4%) included the term ‘exacerbation’. Two of the 27 papers (7%) defined the term flare and both included patient report of changes in symptoms or signs. One of 16 papers (6%) defined exacerbation, which was taken as one new HS lesion. The terms ‘recurrence’ and ‘relapse’ were more apt to be defined: 13% (13 of 100) and 14% (six of 44), respectively. Conclusions The lack of a specific and measurable definition of HS flare is a barrier to assessment of this important outcome. Once a specific and measurable definition is established, validated and reliable measures of HS flare can be incorporated into future studies. What's already known about this topic? Hidradenitis suppurativa (HS) is a chronic, relapsing inflammatory skin condition. The ability to assess flares is important to people who have HS; however, it is unclear how this is defined. HS flare is one of the core outcomes in the core outcome set for HS clinical trials; however, it is unclear how this should be assessed. What does this study add? This literature review reveals the paucity of measurable definitions associated with the use of the term ‘flare’ in the HS literature. It also highlights the variation and lack of a validated and reliable measure of HS flare.

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Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of a phase 3 open-label extension study

Cited by 142 publications

References 19 publications

Quality of life measurement in hidradenitis suppurativa: position statement of the European Academy of Dermatology and Venereology task forces on Quality of Life and Patient‐Oriented Outcomes and Acne, Rosacea and Hidradenitis Suppurativa

Quality of life measurement in hidradenitis suppurativa: position statement of the European Academy of Dermatology and Venereology task forces on Quality of Life and Patient‐Oriented Outcomes and Acne, Rosacea and Hidradenitis Suppurativa

Associations of cutaneous and extracutaneous infections with hidradenitis suppurativa in U.S. children and adults

A narrative review of the definition of ‘flare’ in hidradenitis suppurativa

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