Key points

Introduction

Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, scarring, debilitating skin disease that usually presents after puberty. HS also inflicts a significant burden on patients. Epidemiologic studies also highlight that patients with HS present several cardiovascular risk factors, such as smoking, obesity, dyslipidemia (low high-density lipoprotein levels and hypertriglyceridemia), diabetes, and metabolic syndrome, at a significantly higher rate compared with healthy controls. This evidence indicates that HS is more than a disease limited to skin and that it displays systemic chronic inflammation characteristics, like psoriasis.

In the evaluation of trials and reported treatment results, disease quantification is of the outmost importance. Hurley stage ( Table 1 ), Modified Sartorius Score (MSS), and HS Physician’s Global Assessment (HS-PGA) ( Table 2 ) are measures that have been used to classify and assess HS disease severity ( Box 1 ). A new score was recently developed, evaluated, and validated as a clinical outcome for assessment of treatment effectiveness, especially for the inflammatory manifestations: the Hidradenitis Suppurativa Clinical Response (HiSCR). The use of this validated, easy-to-use score is recommended in both research and daily clinical practice and it allows easier comparisons when assessing different trials. At present the inconsistencies in reported outcomes make such comparisons difficult.

A variety of treatment methods are available for HS, but only a few of them are based on high-quality evidence. This article gives an overview of the currently available evidence for the pharmacologic as well as invasive treatment modalities of HS to facilitate rational decision making in daily clinical practice and elucidate recommendations for future randomized clinical trials.

Introduction

Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, scarring, debilitating skin disease that usually presents after puberty. HS also inflicts a significant burden on patients. Epidemiologic studies also highlight that patients with HS present several cardiovascular risk factors, such as smoking, obesity, dyslipidemia (low high-density lipoprotein levels and hypertriglyceridemia), diabetes, and metabolic syndrome, at a significantly higher rate compared with healthy controls. This evidence indicates that HS is more than a disease limited to skin and that it displays systemic chronic inflammation characteristics, like psoriasis.

In the evaluation of trials and reported treatment results, disease quantification is of the outmost importance. Hurley stage ( Table 1 ), Modified Sartorius Score (MSS), and HS Physician’s Global Assessment (HS-PGA) ( Table 2 ) are measures that have been used to classify and assess HS disease severity ( Box 1 ). A new score was recently developed, evaluated, and validated as a clinical outcome for assessment of treatment effectiveness, especially for the inflammatory manifestations: the Hidradenitis Suppurativa Clinical Response (HiSCR). The use of this validated, easy-to-use score is recommended in both research and daily clinical practice and it allows easier comparisons when assessing different trials. At present the inconsistencies in reported outcomes make such comparisons difficult.

A variety of treatment methods are available for HS, but only a few of them are based on high-quality evidence. This article gives an overview of the currently available evidence for the pharmacologic as well as invasive treatment modalities of HS to facilitate rational decision making in daily clinical practice and elucidate recommendations for future randomized clinical trials.

Methodology

In order to objectively identify all randomized controlled clinical trials (RCTs) for the treatment of HS, a systematic search was undertaken in the electronic databases MEDLINE, EMBASE, and CENTRAL up to January 30 2015, using a draft search strategy for RCTs for MEDLINE (OVID), as suggested in the Cochrane Handbook. Eligible criteria were RCTs that included patients with HS. Study designs other than RCTs were excluded. Conference abstracts and review articles were also excluded. There was a restriction for the English language. Information from each study was extracted using a standardized data extraction form. To assess the methodological quality, the Risk-of-bias tool suggested in the Cochrane Handbook for Systematic Reviews of Interventions was used. The following items were critically appraised and extracted: method of generation of the randomization sequence, allocation concealment, blinding of participants, researchers and outcome assessors, incomplete outcome data (attrition bias), and selective reporting (reporting bias). In addition, the baseline characteristics of study groups were checked for confounding factors in order to rule out selection bias.

Results

The systematic search provided 197 results. After screening, 11 studies met the inclusion criteria. The selection process is summarized in Fig. 1 . General study characteristics are summarized in Table 3 and the most important results in Table 4 . Four studies involved biologic therapy with anti–tumor necrosis factor (TNF) alpha. Two studies investigated the role of antibiotics, and 1 study investigated hormonal therapy. Also, 3 studies on laser treatment and 1 study of surgical treatment were included. The methodological quality of all studies is separately presented in Fig. 2 and pooled in a graph in Fig. 3 .

Search strategy. Eleven RCTs were identified and included in this review. The general characteristics of these studies are included in Table 3 .

Table 3

Characteristics of RCTs for the treatment of HS

Citation	Setting	Methods	Patients	Intervention Groups	Control Group	Limitations
Clemmensen, 1983	Denmark	Single-center, double-blind, placebo-controlled trial	30 patients with HS Hurley I and mild Hurley II	13 Topical CL 1% (dosing schedule unknown) for 12 wk	14 PL for 12 wk	Unjustifiable sample size, no intention-to-treat analysis
Mortimer et al, 1986	United Kingdom	Single-center, double-blind, controlled, crossover trial	24 F patients with HS with moderate to severe HS	10 oral ethinyl estradiol 50 μg/CPA 50 mg (each menstrual cycle) for 12 mo (with crossover at 6 mo)	8 oral ethinyl estradiol 50 μg/norgestrel 500 μg (each menstrual cycle) for 12 mo (with crossover at 6 mo)	Unjustifiable sample size, no intention-to-treat analysis
Jemec & Wendelboe, 1998	Denmark	Single-center, randomized, double-blind, controlled trial	46 patients with HS (39 F, 7 M), Hurley I and II	16 (13 F, 3 M) oral TCN 500 mg bid plus topical PL, minimum of 3 mo	18 (15 F, 3 M) topical CL 1% bid plus oral PL, minimum of 3 mo	Unjustifiable sample size, no intention-to-treat analysis
Buimer et al, 2008	Netherlands	Single-center, randomized, controlled trial	200 patients with HS	124 (108 F, 16 M) surgical excision with PC plus GC	76 (72 F, 4 M) surgical excision with PC alone	No clear assessment of baseline severity
Mahmoud et al, 2010	United States	Single-center, randomized, controlled split-body trial	22 patients with HS (19 F, 3 M), Hurley II	Nd:YAG laser monthly for 4 mo plus BP wash 10% and CL 1% lotion	BP wash 10% and CL 1% lotion alone	No clear report on side effects
Adams et al, 2010	United States	Single-center, randomized, double-blind, placebo-controlled trial	20 patients with HS with moderate to severe HS	10 (6 F, 4 M), ETA SC 50 mg twice/wk for 12 wk	10 (7 F, 3 M), PL SC 50 mg twice/wk for 12 wk	Unjustifiable sample size
Grant et al, 2010	United States	Single-center, randomized, double-blind, placebo-controlled, crossover trial	38 patients with HS with moderate to severe HS	15 (12 F, 3 M) IFX (5 mg/kg) IV on wk 0, 2, and 6	23 (14 F, 9 M) PL (5 mg/kg) IV on wk 0, 2, and 6 (with crossover at 8 wk)	—
Highton et al, 2011	United Kingdom	Single-center, randomized, controlled split-body trial	18 HS (15 F, 3 M) patients, Hurley II and III	IPL twice/wk for 4 wk	No treatment	Unjustifiable sample size, no clear report on side effects
Miller et al, 2011	Denmark	Two-center, randomized, double-blind, placebo-controlled trial	21 patients with HS with moderate to severe HS	15 (12 F, 3 M) ADA SC 80 mg at baseline, 40 mg eow for 12 wk	6 (5 F, 1 M) PL SC 80 mg at baseline, 40 mg eow for 12 wk	Early termination of recruitment, difference in baseline severity
Kimball et al, 2012	United States, Denmark, Netherlands, Germany	Multicenter, randomized, double-blind, placebo-controlled trial	154 patients with HS with moderate to severe HS	51 (36 F, 15 M) ADA SC 160 mg wk 0, 80 mg wk 2, 40 mg weekly for 16 wk 52 (38 F, 14 M) ADA SC 80 mg wk 0, 40 mg eow for 16 wk	51 (36 F, 15 M) PL for 16 wk	—
Fadel & Tawfik, 2015	Egypt	Single-center, randomized, controlled, split-body trial	10 patients with HS (7 F, 3 M) 4 Hurley I, 4 Hurley II, 2 Hurley III	NMB gel plus IPL, twice monthly, maximum 6 mo	Free NMB gel plus IPL, twice monthly, maximum of 6 mo	Unjustifiable sample size

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