Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa

Kimball, Alexa B.; Okun, Martin; Williams, David A.; Gottlieb, Alice B.; Papp, Kim; Zouboulis, Christos C.; Armstrong, April W.; Kerdel, Francisco A.; Gold, Michael H.; Forman, Seth; Korman, Neil J.; Giamarellos‐Bourboulis, Evangelos J.; Crowley, Jeffrey; Lynde, Charles; Réguiai, Z.; Prens, E.P.; Alwawi, Eihab; Mostafa, Nael M.; Pinsky, Brett; Sundaram, Murali; Gu, Yihua; Carlson, Dawn M.; Jemec, Gregor B. E.

doi:10.1056/nejmoa1504370

Cited by 592 publications

(713 citation statements)

References 25 publications

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“…Administration of adalimumab with a cumulative response rate of 58% (improvement ≥50% in 23 patients) has been reported in case reports with 42 patients with moderate-to-severe HS [19,100,101,102,103]. Adalimumab efficacy in HS is also supported by prospective open studies [19,104] and prospective, randomized, double-blind, placebo-controlled surveys [17,105] involving over 800 HS patients, the vast majority of whom were included in 2 phase III studies [106]. Moreover, the European Medicine Agency has recently accepted HS as an indication for adalimumab.…”

Section: Treatmentmentioning

confidence: 94%

Medical and Surgical Treatment of Hidradenitis Suppurativa: A Review

Scuderi

Monfrecola

Dessy

et al. 2017

Skin Appendage Disord

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Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease presenting with painful nodules, abscesses, sinus tracts, and scarring primarily affecting apocrine gland-rich intertriginous areas. HS prevalence ranges from 0.05 to 1%. The central pathogenic event in HS is believed to be the occlusion of the upper part of the folliculopilosebaceous unit, leading to the rupture of the sebofollicular canal with the consequent development of perifollicular lymphohistiocytic inflammation. The HS treatment choices are influenced by disease severity and its individual subjective impact, involving both medical and surgical interventions. However, given the chronic nature of HS, its destructive impact on social, working, and daily life of patients, its management is often frustrating for both the patient and physician. Hence, prompt and effective management strategies are urgently needed and a multidisciplinary approach is advocated. Therefore, in this article, we highlighted the main features of HS (clinical aspects, epidemiology, pathogenesis, diagnostic criteria, classifications, comorbidities, and treatments), so that awareness of this disease might be heightened in primary care physicians and surgeons, who may be the first health care providers to see patients with this disease owing to its characteristic clinical presentation (inflammatory nodules, abscesses, sinus tract, etc.).

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Section: Treatmentmentioning

confidence: 94%

Medical and Surgical Treatment of Hidradenitis Suppurativa: A Review

Scuderi

Monfrecola

Dessy

et al. 2017

Skin Appendage Disord

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“…While clinical trials have demonstrated the efficacy of adalimumab in reducing disease burden, they did not sufficiently examine the clinical response in patients with SOC (Table 1) [33-36]. One study was conducted solely in Caucasian and Romany individuals, while another consisted of 80–88% Caucasians [33, 35]. A Danish trial did not report race for any participants [36].…”

Section: Treatment Response In Socmentioning

confidence: 99%

Hidradenitis Suppurativa: Disease Burden and Etiology in Skin of Color

2017

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Hidradenitis suppurativa (HS) is a chronic, debilitating skin disease. Although most studies on HS are conducted in largely Caucasian populations, evidence demonstrates a higher prevalence in patients with skin of color, including African and Hispanic populations. These racial subgroups are likely at risk for greater disease burden due to a higher prevalence of components of the metabolic syndrome, comorbid depression, and low socioeconomic status; however, there is a paucity of research in these populations. Additionally, studies examining the genetic and anatomical basis for HS, as well as the response to HS therapies, are lacking for patients with skin of color. Complicating this issue is the limited access to effective medical care, including dermatologists, for African and Hispanic populations as well as other minority groups. In this review, we identify gaps in the knowledge base, highlight the association between HS and patients with skin of color, and provide direction for much needed research into this condition.

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“…1 Two phase III multicenter trials of adalimumab were recently completed, PIONEER I and II, enrolling 633 patients. 97 Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab 40 mg weekly than for the placebo groups: 41.8% versus 26.0% in PIONEER I and 58.9% versus 27.6% in PIO-NEER II. 97 The differences between the two trials could be related to the fact that in PIONEER I, patients receiving oral antibiotics had to stop treatment for at least 28 days before baseline whereas in PIONEER II they were allowed to continue treatment with antibiotics (tetracycline class) in stable doses.…”

Section: -Biologic Agentsmentioning

confidence: 89%

“…97 Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab 40 mg weekly than for the placebo groups: 41.8% versus 26.0% in PIONEER I and 58.9% versus 27.6% in PIO-NEER II. 97 The differences between the two trials could be related to the fact that in PIONEER I, patients receiving oral antibiotics had to stop treatment for at least 28 days before baseline whereas in PIONEER II they were allowed to continue treatment with antibiotics (tetracycline class) in stable doses. Adalimumab 160 mg week 0, 80 mg week 2, then 40 mg weekly since week 4 is currently approved for the treatment of moderate to severe HS.…”

Section: -Biologic Agentsmentioning

confidence: 89%

Update on Hidradenitis Suppurativa (Part I): Epidemiology, Pathogenesis, Severity assessment and Comorbidities

Silva

Azevedo

Lisboa

2018

SPDV

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Hidradenitis suppurativa (HS) is as a chronic, inflammatory and recurrent skin disease of the hair follicle. Prevalence of HS is a matter of debate, with estimate rates as low as 0.00033% and as high as 4.1%. HS prevalence appears significantly higher in women and has a mean age of onset in the early 20s. The primary histopathologic event seems to be a follicular hyperkeratosis with plugging, dilatation and rupture of the hair follicle resulting with subsequent inflammation and formation of abscesses and sinus tracts. The cause of this is likely multifactorial, involving genetic factors, cigarette smoking, mechanical stress, obesity, immune aberrant response and hormonal abnormalities. HS, as a chronic inflammatory dermatosis, is associated with a variety of concomitant and secondary diseases such as metabolic syndrome, inflammatory and rheumatologic diseases, depression and malignancy, and, for this reason HS management often requires a multidisciplinary team.

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Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa

Cited by 592 publications

References 25 publications

Medical and Surgical Treatment of Hidradenitis Suppurativa: A Review

Medical and Surgical Treatment of Hidradenitis Suppurativa: A Review

Hidradenitis Suppurativa: Disease Burden and Etiology in Skin of Color

Update on Hidradenitis Suppurativa (Part I): Epidemiology, Pathogenesis, Severity assessment and Comorbidities

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