A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

I Miller; C D Lynggaard; S Lophaven; C Zachariae; D N Dufour; G B E Jemec

doi:10.1111/j.1365-2133.2011.10339.x

A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

I Miller, C D Lynggaard, S Lophaven, C Zachariae, D N Dufour, G B E Jemec

Department of Clinical Medicine

140 Citations (Scopus)

Abstract

BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed.

OBJECTIVES: To test the efficacy of adalimumab in HS.

METHODS: This was a prospective, randomized, double-blinded, placebo-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring. Recruitment was terminated early due to expiry date of trial medication.

RESULTS: Twenty-one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after 6 weeks and an almost significant reduction was seen after 12 weeks of active treatment (-10·7 vs. 7·5, P = 0·024 and -11·3 vs. 5·8, P = 0·07) when compared with the placebo group.

CONCLUSIONS: A significant reduction in HS severity was gained after 6 weeks. No long-term curative effect was uniformly seen.

Original language	English
Journal	British Journal of Dermatology
Volume	165
Issue number	2
Pages (from-to)	391-398
Number of pages	8
ISSN	0007-0963
DOIs	https://doi.org/10.1111/j.1365-2133.2011.10339.x
Publication status	Published - Aug 2011

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title = "A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa",

abstract = "BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed.OBJECTIVES: To test the efficacy of adalimumab in HS.METHODS: This was a prospective, randomized, double-blinded, placebo-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring. Recruitment was terminated early due to expiry date of trial medication.RESULTS: Twenty-one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after 6 weeks and an almost significant reduction was seen after 12 weeks of active treatment (-10·7 vs. 7·5, P = 0·024 and -11·3 vs. 5·8, P = 0·07) when compared with the placebo group.CONCLUSIONS: A significant reduction in HS severity was gained after 6 weeks. No long-term curative effect was uniformly seen.",

keywords = "Adult, Anti-Inflammatory Agents, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Double-Blind Method, Female, Hidradenitis Suppurativa, Humans, Injections, Subcutaneous, Male, Middle Aged, Pain, Pain Measurement, Prospective Studies, Quality of Life, Treatment Outcome",

author = "I Miller and Lynggaard, {C D} and S Lophaven and C Zachariae and Dufour, {D N} and Jemec, {G B E}",

note = "{\textcopyright} 2011 The Authors. BJD {\textcopyright} 2011 British Association of Dermatologists 2011.",

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doi = "10.1111/j.1365-2133.2011.10339.x",

language = "English",

volume = "165",

pages = "391--398",

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T1 - A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

AU - Miller, I

AU - Lynggaard, C D

AU - Lophaven, S

AU - Zachariae, C

AU - Dufour, D N

AU - Jemec, G B E

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N2 - BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed.OBJECTIVES: To test the efficacy of adalimumab in HS.METHODS: This was a prospective, randomized, double-blinded, placebo-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring. Recruitment was terminated early due to expiry date of trial medication.RESULTS: Twenty-one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after 6 weeks and an almost significant reduction was seen after 12 weeks of active treatment (-10·7 vs. 7·5, P = 0·024 and -11·3 vs. 5·8, P = 0·07) when compared with the placebo group.CONCLUSIONS: A significant reduction in HS severity was gained after 6 weeks. No long-term curative effect was uniformly seen.

AB - BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed.OBJECTIVES: To test the efficacy of adalimumab in HS.METHODS: This was a prospective, randomized, double-blinded, placebo-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring. Recruitment was terminated early due to expiry date of trial medication.RESULTS: Twenty-one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after 6 weeks and an almost significant reduction was seen after 12 weeks of active treatment (-10·7 vs. 7·5, P = 0·024 and -11·3 vs. 5·8, P = 0·07) when compared with the placebo group.CONCLUSIONS: A significant reduction in HS severity was gained after 6 weeks. No long-term curative effect was uniformly seen.

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KW - Antibodies, Monoclonal, Humanized

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KW - Female

KW - Hidradenitis Suppurativa

KW - Humans

KW - Injections, Subcutaneous

KW - Male

KW - Middle Aged

KW - Pain

KW - Pain Measurement

KW - Prospective Studies

KW - Quality of Life

KW - Treatment Outcome

U2 - 10.1111/j.1365-2133.2011.10339.x

DO - 10.1111/j.1365-2133.2011.10339.x

M3 - Journal article

C2 - 21457202

SN - 0007-0963

VL - 165

SP - 391

EP - 398

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 2

ER -

A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

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