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Meta-Analysis
. 2015 Oct 7;2015(10):CD010081.
doi: 10.1002/14651858.CD010081.pub2.

Interventions for hidradenitis suppurativa

John R Ingram  1 , Pick-Ngor Woo, Ser Ling Chua, Anthony D Ormerod, Nemesha Desai, Anneke C Kai, Kerry Hood, Tara Burton, Francisco Kerdel, Sarah E Garner, Vincent Piguet
Affiliations
Meta-Analysis

Interventions for hidradenitis suppurativa

John R Ingram et al. Cochrane Database Syst Rev. .

Abstract

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterised by recurrent painful boils in flexural sites, such as the axillae and groin, that affects about 1% of the population, with onset in early adulthood.

Objectives: To assess the effects of interventions for HS in people of all ages.

Search methods: We searched the following databases up to 13 August 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 7, 2015), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We also searched five trials registers and handsearched the conference proceedings of eight dermatology meetings. We checked the reference lists of included and excluded studies for further references to relevant trials.

Selection criteria: Randomised controlled trials (RCTs) of all interventions for hidradenitis suppurativa.

Data collection and analysis: Two review authors independently assessed study eligibility and methodological quality and performed data extraction. Our primary outcomes were quality of life, measured by a validated dermatology-specific scale, and adverse effects of the interventions.

Main results: Twelve trials, with 615 participants, met our inclusion criteria. The median number of participants in each trial was 27, and median trial duration was 16 weeks. The included studies were conducted over a 32-year time period, from 1983 to 2015. A single RCT that was underpowered to detect clinically meaningful differences investigated most interventions.There were four trials of anti-TNF-α (tumour necrosis factor-alpha) therapies, which included etanercept, infliximab, and adalimumab. Adalimumab 40 mg weekly improved the Dermatology Life Quality Index (DLQI) score in participants with moderate to severe HS by 4.0 points relative to placebo (95% confidence interval (CI) -6.5 to -1.5 points), an effect size approximately equal to the DLQI minimal clinically important difference. We reduced the evidence quality to 'moderate' because the effect size was based on the results of only one study. In a meta-analysis of two studies with 124 participants, standard dose adalimumab 40 mg every other week was ineffective compared with placebo (moderate quality evidence). In a smaller study of 38 participants, of whom only 33 provided efficacy data, infliximab 5 mg/kg treatment improved DLQI by 8.4 DLQI points after eight weeks. Etanercept 50 mg twice weekly was well tolerated but ineffective.In a RCT of 200 participants, no difference was found in surgical complications (week one: risk ratio (RR) 0.78, 95% CI 0.58 to 1.05, moderate quality evidence) or risk of recurrence (after three months: RR 0.96, 95% CI 0.68 to 1.34, moderate quality evidence) in those randomised to receive a gentamicin-collagen sponge prior to primary closure compared with primary closure alone.RCTs of other interventions, including topical clindamycin 1% solution; oral tetracycline; oral ethinylestradiol 50 mcg with either cyproterone acetate 50 mg or norgestrel 500 mcg; intense pulsed light; neodymium-doped yttrium aluminium garnet (Nd:YAG) laser; methylene blue gel photodynamic therapy; and staphage lysate, were relatively small studies, preventing firm conclusions due to imprecision.

Authors' conclusions: Many knowledge gaps exist in RCT evidence for HS. Moderate quality evidence exists for adalimumab, which improves DLQI score when 40 mg is given weekly, twice the standard psoriasis dose. However, the 95% confidence interval includes an effect size of only 1.5 DLQI points, which may not be clinically relevant, and the safety profile of weekly dosing has not been fully established. Infliximab also improves quality of life, based on moderate quality evidence.More RCTs are needed in most areas of HS care, particularly oral treatments and the type and timing of surgical procedures. Outcomes should be validated, ideally, including a minimal clinically important difference for HS.

PubMed Disclaimer

Conflict of interest statement

John R Ingram: John R Ingram is a local PI (principal investigator) for an observational study sponsored by AbbVie, manufacturers of adalimumab. He has not acted as a consultant for the manufacturer or taken part in paid Advisory Boards. Pick‐Ngor Woo: nothing to declare. Ser Ling Chua: nothing to declare. Anthony D Ormerod: nothing to declare. Nemesha Desai: "I have received consulting fees for advisory board work for AbbVie, which produces adalimumab." Anneke C Kai: nothing to declare. Kerry Hood: nothing to declare. Tara Burton: "I have received honorarium for speaking at AbbVie meetings in July 2014 and January 2015 about my personal patient journey. In June 2015, the HS Trust received a £5000 core funding grant from AbbVie, which produces adalimumab." Francisco Kerdel: "I have received honorariums for research or speaking agreements from Janssen Biotech, Inc., which produces Remicade® (infliximab); AbbVie, formally Abbott, which produces Humira® (adalimumab); and Amgen/Pfizer, which produces Enbrel® (etanercept)." Sarah E Garner: nothing to declare. Vincent Piguet: "I undertake personal advisory work with Pfizer, AbbVie, Janssen, Novartis, and Almirall. I have received support to my Department from AbbVie, Almirall, Alliance, Beiersdorf UK Ltd, Biotest, Celgene, Galderma, Genus Pharma, Janssen, LEO Pharma, Meda, MSD, Novartis, Pfizer, Sinclair Pharma, Spirit Pharmaceuticals, Stiefel, Sumed, and TyPham. The Department also received financial support from Dermatology Life Quality Index (DLQI) copyright. Please note: adalimumab is produced by AbbVie; ustekinumab is produced by Janssen; infliximab is produced by MSD; and etanercept is produced by Pfizer."

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' graph: review authors' judgements about each 'risk of bias' item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each 'risk of bias' item for each included study.
1.1
1.1. Analysis
Comparison 1 Topical clindamycin versus placebo, Outcome 1 Number of participants reporting non‐serious adverse effects.
2.1
2.1. Analysis
Comparison 2 Oral tetracycline versus topical clindamycin, Outcome 1 Participant global assessment VAS (higher scores associated with more severe disease).
2.2
2.2. Analysis
Comparison 2 Oral tetracycline versus topical clindamycin, Outcome 2 Pain VAS (higher score is associated with more pain).
2.3
2.3. Analysis
Comparison 2 Oral tetracycline versus topical clindamycin, Outcome 3 Nodules score.
2.4
2.4. Analysis
Comparison 2 Oral tetracycline versus topical clindamycin, Outcome 4 Abscesses score.
2.5
2.5. Analysis
Comparison 2 Oral tetracycline versus topical clindamycin, Outcome 5 Physician Global Assessment VAS (higher scores associated with more severe disease).
3.1
3.1. Analysis
Comparison 3 Ethinylestradiol and cyproterone acetate versus ethinylestradiol and norgestrel, Outcome 1 Number of participants reporting non‐serious adverse effects.
3.2
3.2. Analysis
Comparison 3 Ethinylestradiol and cyproterone acetate versus ethinylestradiol and norgestrel, Outcome 2 Participant global assessment VAS (higher number indicates improvement).
4.1
4.1. Analysis
Comparison 4 Infliximab versus placebo, Outcome 1 At least 50% decrease in HS Severity Index.
4.2
4.2. Analysis
Comparison 4 Infliximab versus placebo, Outcome 2 Physician Global Assessment (judged to be clear, excellent, or good clinical response).
5.1
5.1. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 1 Change in DLQI score (LOCF) (negative values indicate improvement in DLQI).
5.2
5.2. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 2 Frequency of serious adverse effects.
5.3
5.3. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 3 Frequency of treatment discontinuation.
5.4
5.4. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 4 Proportion of participants with infectious adverse effects.
5.5
5.5. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 5 Change in Pain VAS (lower number indicates improvement).
5.6
5.6. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 6 Proportion with improvement in pain.
5.7
5.7. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 7 Change in Sartorius scale score (LOCF) (higher scores associated with more severe disease).
5.8
5.8. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 8 Physician Global Assessment (at least a grade 2 improvement from baseline).
5.9
5.9. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 9 Total Work Productivity Impairment (TWPI) score (imputation) (lower number indicates less impairment).
5.10
5.10. Analysis
Comparison 5 Adalimumab every other week versus placebo, Outcome 10 Total Work Productivity Impairment (TWPI) score (LOCF) (lower number indicates less impairment).
6.1
6.1. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 1 Change in DLQI score (imputation) (negative values indicate improvement in DLQI).
6.2
6.2. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 2 Change in DLQI score (LOCF) (negative values indicate improvement in DLQI).
6.3
6.3. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 3 Frequency of serious adverse effects.
6.4
6.4. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 4 Frequency of treatment discontinuation.
6.5
6.5. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 5 Proportion of participants with infectious adverse effects.
6.6
6.6. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 6 Proportion of participants with improvement in pain.
6.7
6.7. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 7 Change in modified Sartorius scale score (imputation) (higher scores associated with more severe disease).
6.8
6.8. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 8 Change in modified Sartorius scale score (LOCF) (higher scores associated with more severe disease).
6.9
6.9. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 9 Physician Global Assessment (at least a grade 2 improvement from baseline).
6.10
6.10. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 10 Total Work Productivity Impairment (TWPI) score (imputation) (lower number indicates less impairment).
6.11
6.11. Analysis
Comparison 6 Adalimumab weekly versus placebo, Outcome 11 Total Work Productivity Impairment (TWPI) score (LOCF) (lower number indicates less impairment).
7.1
7.1. Analysis
Comparison 7 Gentamicin sponge versus primary closure alone, Outcome 1 Adverse effects ‐ complication rate at 1 week after surgery.
7.2
7.2. Analysis
Comparison 7 Gentamicin sponge versus primary closure alone, Outcome 2 Adverse effects ‐ complication rate at 3 months after surgery.
7.3
7.3. Analysis
Comparison 7 Gentamicin sponge versus primary closure alone, Outcome 3 Recurrence rate at 3 months after surgery.
8.1
8.1. Analysis
Comparison 8 Intense pulsed light versus no treatment, Outcome 1 Participant global assessment: satisfaction with treatment.
9.1
9.1. Analysis
Comparison 9 Nd:YAG laser versus topical control, Outcome 1 Modified HS‐LASI score after 3 months (higher scores associated with more severe disease).
9.2
9.2. Analysis
Comparison 9 Nd:YAG laser versus topical control, Outcome 2 Percentage change in modified HS‐LASI score after 5 months compared with baseline (higher scores associated with more severe disease).
10.1
10.1. Analysis
Comparison 10 Niosomal methylene blue gel PDT versus free methylene blue gel PDT, Outcome 1 HS‐LASI score at end of study (6 months) (higher scores associated with more severe disease).
11.1
11.1. Analysis
Comparison 11 Staphage lysate versus placebo broth, Outcome 1 Physician Global Assessment (judged to be 'improved').
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD010081

References

References to studies included in this review

Adams 2010 {published data only}
    1. Adams DR, Yankura JA, Fogelberg AC, Anderson BE. Treatment of hidradenitis suppurativa with etanercept injection. Archives of Dermatology 2010;146(5):501‐4. [MEDLINE: ] - PubMed
Angel 1987 {published data only}
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Buimer 2008 {published data only}
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    1. Grant A, Gonzalez T, Montgomery MO, Cardenas V, Kerdel FA. Infliximab therapy for patients with moderate to severe hidradenitis suppurativa: a randomized, double‐blind, placebo‐controlled crossover trial. Journal of the American Academy of Dermatology 2010;62(2):205‐17. [MEDLINE: ] - PubMed
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Highton 2011 {published data only}
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Jemec 1998 {published data only}
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    1. Gottlieb A, Menter A, Armstrong A, Cui N, Yamaguchi Y. Adalimumab treatment in women with moderate to severe hidradenitis suppurativa using a novel endpoint, HISCR (hidradenitis suppurativa clinical response): Analysis from the placebo‐controlled portion of a phase ii, randomized, double‐blind study. 61st Annual Scientific Meeting of the Society for Gynecologic Investigation, SGI 2014 Florence Italy. Conference Start: 20140326 Conference End: 20140329. Reproductive Sciences 2014;21(3 Suppl 1):220A‐221A. [EMBASE: 71380256]
    1. Gottlieb AB, Menter A, Belknap K, Chen K, Teixeira HD. Efficacy and safety of adalimumab treatment in women with moderate to severe hidradenitis suppurativa: Analysis from the placebo‐controlled portion of a phase ii, randomized, double‐blind study. 20th FIGO World Congress of Gynecology and Obstetrics Rome Italy. Conference Start: 20121007 Conference End: 20121012. International Journal of Gynaecology and Obstetrics 2012;119:S360. [EMBASE: 70905615]
    1. Jemec G, Sobell J, Scheinfeld N, Sood S, Gu Y. Efficacy results using a novel hidradenitis suppurativa endpoint, HiSCR (hidradenitis suppurativa clinical response), from the placebo‐controlled phase of a phase 2 adalimumab study. Conference: 72nd Annual Meeting of the American Academy of Dermatology Denver, CO United States. Conference Start: 20140321 Conference End: 20140325. Journal of the American Academy of Dermatology 2014;70(5 Suppl 1):AB42. [EMBASE: 71390261]
    1. Kimball A, Jemec G, Okun M, Gu Y. Efficacy and safety of adalimumab in treatment of moderate to severe hidradenitis suppurativa: results from the placebo‐controlled portion of a phase ii, randomized, double‐blind study. Conference: 69th Annual Meeting of the American Academy of Dermatology New Orleans, LA United States. Conference Start: 20110204 Conference End: 20110208. Journal of the American Academy of Dermatology 2011;64(2 Suppl 1):AB155. [EMBASE: 70331898]
    1. Kimball A, Williams D, Jemec G, Gu Y. Efficacy and safety of adalimumab for moderate to severe hidradenitis suppurativa: Results from the open‐label phase of a 52‐week phase II, randomized, study. 70th Annual Meeting of the American Academy of Dermatology San Diego, CA United States. Conference Start: 20120316 Conference End: 20120320. Journal of the American Academy of Dermatology 2012;66(4 Suppl 1):AB50. [EMBASE: 70704053]
Miller 2011 {published data only}
    1. Miller I, Lynggaard CD, Lophaven S, Zachariae C, Dufour DN, Jemec GB. A double‐blind placebo‐controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa. British Journal of Dermatology 2011;165(2):391‐8. [MEDLINE: ] - PubMed
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Tierney 2009 {published data only}
    1. Hamzavi I, Mahmoud B, Tierney E, Hexsel C, Pui J, Ozog O. Prospective clinical and histopathologic study of hidradenitis suppurativa treated with laser. 29th Annual Conference of the American Society for Laser Medicine and Surgery National Harbor, MD United States. Conference Start: 20090401 Conference End: 20090405. Lasers in Surgery and Medicine 2009;41:100. [EMBASE: 70332912]
    1. Mahmoud B, Hexsel C, Ozog D, Tierney E, Hamzavi I. Clinical and histopathologic evaluation of hidradenitis suppurativa treated with long‐pulsed Nd:YAG laser. 67th Annual Meeting of the American Academy of Dermatology, AAD San Francisco, CA United States. Conference Start: 20090306 Conference End: 20090310. Journal of the American Academy of Dermatology 2009;60(3 Suppl 1):AB192. [EMBASE: 70142480]
    1. Mahmoud BH, Tierney E, Hexsel CL, Pui J, Ozog DM, Hamzavi IH. Prospective controlled clinical and histopathologic study of hidradenitis suppurativa treated with the long‐pulsed neodymium:yttrium‐aluminium‐garnet laser. Journal of the American Academy of Dermatology 2010;62(4):637‐45. [MEDLINE: ] - PubMed
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References to studies excluded from this review

Morgan 1983 {published data only}
    1. Morgan WP, Harding KG, Hughes LE. A comparison of skin grafting and healing by granulation, following axillary excision for hidradenitis suppurativa. Annals of the Royal College of Surgeons of England 1983;65(4):235‐6. [MEDLINE: ] - PMC - PubMed
NCT00722800 {unpublished data only}
    1. NCT00722800. A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS. clinicaltrials.gov/ct2/show/NCT00722800 (accessed 2 April 2015).
Puri 2011 {published data only}
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References to studies awaiting assessment

EUCTR2006‐005405‐67 {published data only}
    1. EUCTR2006‐005405‐67. Study of the effectiveness and tolerance of L35 versus placebo in the treatment of hidradenitis suppurativa (Verneuil 's Disease) [Etude de l'efficacité et de la tolérance du L35 versus placebo dans le traitement de l'hidradénite suppurée (Maladie de Verneuil)]. www.clinicaltrialsregister.eu/ctr‐search/search?query=2006‐005405‐67 (accessed 2 April 2015).
EUCTR2007‐000534‐39 {published data only}
    1. EUCTR2007‐000534‐39. Comparative randomised study on the effectiveness of the treatment of hidradenitis suppurative disease or verneuil by sub cutaneous injections of botulinum toxin versus placebo [Etude comparative randomisee intra‐individuelle de l'efficacite du traitement d'hidradenite suppuree ou maladie de verneuil par injections sous cutanee de toxine botulinique versus placebo]. www.clinicaltrialsregister.eu/ctr‐search/trial/2007‐000534‐39/FR (accessed 2 April 2015).
Servant 2002 {published data only (unpublished sought but not used)}
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References to ongoing studies

NCT01063270 {unpublished data only}
    1. NCT01063270. Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa. clinicaltrials.gov/show/NCT01063270 (accessed 17 September 2014).
NCT01468207 {published and unpublished data}
    1. Jemec GB, Sundaram M, Pinsky B, Gu Y, Williams D, Bao Y. Adalimumab improves treatment satisfaction with medication (TS‐M) in patients with moderate to severe Hidradenitis Suppurativa (HS) in a 12‐week randomised controlled trial (PIONEER I). 44th Annual Meeting of the European Society for Dermatological Research Copenhagen Denmark. Conference Start: 20140910 Conference End: 20140913. Journal of Investigative Dermatology 2014;134:S31. [EMBASE: 71606497]
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    1. NCT01468207. Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa (PIONEER I). clinicaltrials.gov/show/NCT01468207 (accessed 17 September 2014).
NCT01468233 {unpublished data only}
    1. Armstrong A, Pinsky B, Sundaram M, Shu L, Okun M, Bao Y. Adalimumab improves health‐related quality of life (HRQoL) in patients with moderate to severe hidradenitis suppurativa (HS): results from the first 12 weeks of PIONEER II. 73rd Annual Meeting of the American Academy of Dermatology San Francisco, CA United States. Conference Start: 20150320 Conference End: 20150324. Journal of the American Academy of Dermatology 2015;72(5 Suppl 1):AB38. [EMBASE: 71894918]
    1. Jemec G, Gottlieb A, Forman S, Giamarellos‐Bourboulis E, Reguiai Z, Gu Y, et al. Efficacy and safety of adalimumab in patients with moderate to severe hidradenitis suppurativa: Results from PIONEER II, a phase 3, randomized, placebo‐controlled trial. 73rd Annual Meeting of the American Academy of Dermatology San Francisco, CA United States. Conference Start: 20150320 Conference End: 20150324. Journal of the American Academy of Dermatology 2015;72(5 Suppl 1):AB45. [EMBASE: 71894944]
    1. Jemec GBE, Sundaram M, Pinsky B, Shu L, Okun, M, Bao Y. Adalimumab improves treatment satisfaction with medication (TS‐M) in patients with moderate to severe hidradenitis suppurativa (HS) in a 12‐week randomized controlled trial (PIONEER II). Journal of the American Academy of Dermatology 2015;72(5 Suppl 1):AB39. [EMBASE: 71894919]
    1. Kimball AB, Pinsky B, Sundaram M, Geng Z, Okun M, Bao Y. Adalimumab is associated with reduced skin pain in patients with moderate to severe hidradenitis suppurativa (HS): Results from the first 12 weeks of PIONEER II. 73rd Annual Meeting of the American Academy of Dermatology San Francisco, CA United States. Journal of the American Academy of Dermatology 2015;72(5 Suppl 1):AB39. [EMBASE: 71894920]
    1. NCT01468233. Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER II). clinicaltrials.gov/show/NCT01468233 (accessed 17 September 2014).
NCT01558375 {unpublished data only}
    1. NCT01558375. Anakinra in Hidradenitis Suppurativa. clinicaltrials.gov/show/NCT01558375 (accessed 17 September 2014).
NCT01818167 {published data only}
    1. NCT01818167. An Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide Wash for the Treatment of Hidradenitis Suppurativa. clinicaltrials.gov/ct2/show/NCT01818167 (accessed 2 April 2015).
NCT01838499 {published data only}
    1. NCT01838499. Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa. clinicaltrials.gov/ct2/show/NCT01838499 (accessed 2 April 2015).
NCT02163746 {published data only}
    1. NCT02163746. Study to Compare Two Treatments for Axillary Hidradenitis Suppurativa: Carbon Dioxide Laser Versus Surgical Deroofing. clinicaltrials.gov/ct2/show/NCT02163746 (accessed 2 April 2015).
NCT02421172 {published data only}
    1. NCT02421172. Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients. clinicaltrials.gov/ct2/show/NCT02421172 (accessed 2 April 2015).

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