Real-world effectiveness and safety of the LAight-therapy in patients with hidradenitis suppurativa.

acne inversa hidradenitis suppurativa laight‐therapy outpatient setting

Journal

Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG
ISSN: 1610-0387
Titre abrégé: J Dtsch Dermatol Ges
Pays: Germany
ID NLM: 101164708

Informations de publication

Date de publication:
28 May 2024
Historique:
received: 04 08 2023
accepted: 18 02 2024
medline: 29 5 2024
pubmed: 29 5 2024
entrez: 28 5 2024
Statut: aheadofprint

Résumé

Hidradenitis suppurativa (HS)/Acne inversa (Ai) is a chronic debilitating disease with limited therapy options. The device-based LAight therapy was approved in Europe in 2017. The aim of this study was to evaluate the effect of real-world care with at least one treatment with LAight therapy on disease activity and burden in 3,437 patients. Patients were included in the analysis if they had a diagnosis of HS and received at least one treatment. The endpoints Hidradenitis Suppurativa Severity Score System (IHS4), pain on the numeric rating scale (pain-NRS) and Dermatology Life Quality Index (DLQI) were analyzed using a linear mixed model for repeated measures (MMRM) over 26 weeks of care with LAight therapy. Furthermore, responder rates were calculated for all endpoints, and the therapy's safety profile and patient satisfaction were thoroughly examined. A significant decrease in IHS4, pain-NRS, and DLQI was achieved during 26 weeks of care with LAight. The BMI at baseline had a significant negative effect on therapy response for pain-NRS and DLQI. This study confirms that LAight therapy leads to satisfactory disease control in all stages of severity and is a valuable addition to the therapeutic repertoire of HS.

Sections du résumé

BACKGROUND AND OBJECTIVES OBJECTIVE
Hidradenitis suppurativa (HS)/Acne inversa (Ai) is a chronic debilitating disease with limited therapy options. The device-based LAight therapy was approved in Europe in 2017. The aim of this study was to evaluate the effect of real-world care with at least one treatment with LAight therapy on disease activity and burden in 3,437 patients.
PATIENTS AND METHODS METHODS
Patients were included in the analysis if they had a diagnosis of HS and received at least one treatment. The endpoints Hidradenitis Suppurativa Severity Score System (IHS4), pain on the numeric rating scale (pain-NRS) and Dermatology Life Quality Index (DLQI) were analyzed using a linear mixed model for repeated measures (MMRM) over 26 weeks of care with LAight therapy. Furthermore, responder rates were calculated for all endpoints, and the therapy's safety profile and patient satisfaction were thoroughly examined.
RESULTS RESULTS
A significant decrease in IHS4, pain-NRS, and DLQI was achieved during 26 weeks of care with LAight. The BMI at baseline had a significant negative effect on therapy response for pain-NRS and DLQI.
CONCLUSIONS CONCLUSIONS
This study confirms that LAight therapy leads to satisfactory disease control in all stages of severity and is a valuable addition to the therapeutic repertoire of HS.

Identifiants

pubmed: 38807028
doi: 10.1111/ddg.15403
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : LENICURA GmbH

Informations de copyright

© 2024 The Author(s). Journal der Deutschen Dermatologischen Gesellschaft published by Wiley‐VCH GmbH on behalf of Deutsche Dermatologische Gesellschaft.

Références

Kurzen H, Kurokawa I, Jemec GB, et al. What causes hidradenitis suppurativa? Exp Dermatol. 2008;17:455‐456;discussion 57–72.
Fimmel S, Zouboulis CC. Comorbidities of hidradenitis suppurativa (acne inversa). Dermatoendocrinol. 2010;2:9‐16.
Zouboulis CC, Bechara FG, Fritz K, et al. [S1 guideline for the treatment of hidradenitis suppurativa /acne inversa * (number ICD‐10 L73.2)]. J Dtsch Dermatol Ges. 2012;10(Suppl 5):S1‐31.
Gulliver W, Zouboulis CC, Prens E, et al. Evidence‐based approach to the treatment of hidradenitis suppurativa/acne inversa, based on the European guidelines for hidradenitis suppurativa. Rev Endocr Metab Disord. 2016;17:343‐351.
Kimball AB, Okun MM, Williams DA, et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016;375:422‐434.
Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate‐to‐severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo‐controlled, double‐blind phase 3 trials. The Lancet. 2023;401:747‐761.
Hafner J, Löser CR, Roka F.Dermatosurgery – from surgical option to integral part of dermatologic therapy. J Dtsch Dermatol Ges. 2023;21:355‐358.
Scholl L, Schneider‐Burrus S, Fritz B, et al. The impact of surgical interventions on the psychosocial well‐being of patients with hidradenitis suppurativa. J Dtsch Dermatol Ges. 2023;21:131‐139.
Garg A, Neuren E, Cha D, et al. Evaluating patients' unmet needs in hidradenitis suppurativa: Results from the Global Survey Of Impact and Healthcare Needs (VOICE) Project. J Am Acad Dermatol. 2020;82:366‐376.
Schultheis M, Grabbe S, Staubach P, et al. Klinische Merkmale von Betroffenen mit Akne inversa. Dtsch Arztebl International. 2023;120:345‐346.
van der Zee HH, van de Bunte M, van Straalen KR. Management of mild hidradenitis suppurativa: our greatest challenge yet. Br J Dermatol. 2022;186:355‐356.
Wilden S, Friis M, Tuettenberg A, et al. Combined treatment of hidradenitis suppurativa with intense pulsed light (IPL) and radiofrequency (RF). J. Dermatol. Treat. 2021;32:530‐537.
Schultheis M, Staubach P, Nikolakis G, et al. LAight® Therapy Significantly Enhances Treatment Efficacy of 16 Weeks of Topical Clindamycin Solution in Hurley I and II Hidradenitis Suppurativa: Results from Period A of RELIEVE, a Multicenter Randomized, Controlled Trial. Dermatology. 2022;238:476‐486.
Schultheis M, Staubach P, Grabbe S, et al. LAight® Therapy Is an Effective Treatment Option to Maintain Long‐Term Remission of Hurley I and II Hidradenitis Suppurativa: Results from Period B of RELIEVE, a Multicenter Randomized, Controlled Trial. Dermatology. 2022;238:1092‐1103.
Zouboulis CC, Tzellos T, Kyrgidis A, et al. Development and validation of the International Hidradenitis Suppurativa Severity Score System (IHS4), a novel dynamic scoring system to assess HS severity. Br J Dermatol. 2017;177:1401‐1409.
Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003;4:407‐414.
Basra MK, Fenech R, Gatt RM, et al. The Dermatology Life Quality Index 1994–2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008;159:997‐1035.
Tzellos T, van Straalen KR, Kyrgidis A, et al. Development and validation of IHS4‐55, an IHS4 dichotomous outcome to assess treatment effect for hidradenitis suppurativa. J Eur Acad Dermatol Venereol. 2023;37:395‐401.
Basra MK, Salek MS, Camilleri L, et al. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230:27‐33.
Pasquale TR, Tan JS. Nonantimicrobial effects of antibacterial agents. Clin Infect Dis. 2005;40:127‐135.
Scheinfeld N. Why rifampin (rifampicin) is a key component in the antibiotic treatment of hidradenitis suppurativa: a review of rifampin's effects on bacteria, bacterial biofilms, and the human immune system. Dermatol Online J. 2016;22.
Mendes‐Bastos P, Macedo R, Duarte R. Treatment of hidradenitis suppurativa with rifampicin: have we forgotten tuberculosis? Br J Dermatol. 2017;177:e150‐e151.
Join‐Lambert O, Ribadeau‐Dumas F, Jullien V, et al. Dramatic reduction of clindamycin plasma concentration in hidradenitis suppurativa patients treated with the rifampinclindamycin combination. Eur J Dermatol. 2014;24:94‐95.
Yang JH, Cho SI, Kim DH, et al. Pilot study of fractional microneedling radiofrequency for hidradenitis suppurativa assessed by clinical response and histology. Clin Exp Dermatol. 2022;47:335‐342.
Zouboulis CC, Desai N, Emtestam L, et al. European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa. J Eur Acad Dermatol Venereol. 2015;29:619‐644.
Karagiannidis I, Nikolakis G, Sabat R, Zouboulis CC. Hidradenitis suppurativa/Acne inversa: an endocrine skin disorder? Rev Endocr Metab Disord. 2016;17:335‐341.
Sabat R, Chanwangpong A, Schneider‐Burrus S, et al. Increased prevalence of metabolic syndrome in patients with acne inversa. PLoS One. 2012;7:e31810.
van Straalen KR, Vanlaerhoven AMJD, Ardon CB, van der Zee HH. Body mass index at the onset of hidradenitis suppurativa. J Dtsch Dermatol Ges. 2021;19:437‐439.
Kromann CB, Ibler KS, Kristiansen VB, Jemec GB. The influence of body weight on the prevalence and severity of hidradenitis suppurativa. Acta Derm Venereol. 2014;94:553‐557.
Kromann CB, Deckers IE, Esmann S, et al. Risk factors, clinical course and long‐term prognosis in hidradenitis suppurativa: a cross‐sectional study. Br J Dermatol. 2014;171:819‐824.
Kaleta KP, Nikolakis G, Hossini AM, et al. Metabolic Disorders/Obesity Is a Primary Risk Factor in Hidradenitis Suppurativa: An Immunohistochemical Real‐World Approach. Dermatology. 2022;238:251‐259.
Nosrati A, Torpey ME, Shokrian N, et al. Adalimumab efficacy is inversely correlated with body mass index (BMI) in hidradenitis suppurativa. Int J Dermatol. 2023;62:764‐769.
Williams J, Guzik C, Wadhera A, Naik H. Increased Doses of Adalimumab are Associated With Clinical Improvement of Hidradenitis Suppurativa. J Drugs Dermatol. 2023;22:615‐618.
Schultheis M, Staubach P, Nikolakis G, et al. A centre‐based, ambulatory care concept for Hidradenitis suppurativa improves disease activity, burden, and patient satisfaction: results from the randomised controlled trial EsmAiL. Br J Dermatol. 2023;189:170‐179.
Kirsten N, Frings V, Nikolakis GD, et al. [Epidemiology, patient quality of life, and treatment costs of hidradenitis suppurativa/acne inversa]. Hautarzt. 2021;72:651‐657.
Kirby JS, Miller JJ, Adams DR, Leslie D. Health care utilization patterns and costs for patients with hidradenitis suppurativa. JAMA Dermatol. 2014;150:937‐944.
Tsentemeidou A, Sotiriou E, Ioannides D, Vakirlis E. Hidradenitis suppurativa‐related expenditure, a call for awareness: systematic review of literature. J Dtsch Dermatol Ges. 2022;20:1061‐1072.
Gáspár K, Hunor Gergely L, Jenei B, et al. Resource utilization, work productivity and costs in patients with hidradenitis suppurativa: a cost‐of‐illness study. Expert Rev Pharmacoecon Outcomes Res. 2022;22:399‐408.
Faverio K, Peitsch WK, Görig T, et al. Patient Preferences in Hidradenitis Suppurativa (APProach‐HS): a discrete choice experiment. J Dtsch Dermatol Ges. 2022;20:1441‐1452.
Schultheis M, Scheuern M, Radkov I. Combining Deroofing with LAight® Therapy for Long‐Term Disease Control of Hurley Stage II Hidradenitis Suppurativa: Case Report. Clin Pract. 2021;11:26‐31.

Auteurs

Alexandra Strobel (A)

Institute of Medical Epidemiology, Biostatistics, and Informatics, Faculty of Medicine, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany.
Profile Centre of Health Sciences Halle, Faculty of Medicine, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany.

Michael Schultheis (M)

Dept. of Dermatology, University Medical Center, Johannes Gutenberg, University, Mainz, Germany.

Petra Staubach (P)

Dept. of Dermatology, University Medical Center, Johannes Gutenberg, University, Mainz, Germany.

Stephan Grabbe (S)

Dept. of Dermatology, University Medical Center, Johannes Gutenberg, University, Mainz, Germany.

Caroline Mann (C)

Dept. of Dermatology, University Medical Center, Johannes Gutenberg, University, Mainz, Germany.

Katharina Hennig (K)

Dept. of Dermatology, University Medical Center, Johannes Gutenberg, University, Mainz, Germany.

Jacek C Szepietowski (JC)

Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.

Lukasz Matusiak (L)

Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.

Piotr Krajewski (P)

Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.

Esther von Stebut (E)

Department of Dermatology, Faculty of Medicine, University of Cologne, Cologne, Germany.

Simone Garcovich (S)

Dermatology Outpatient Office Dr. Simone Garcovich, Rome, Italy.

Hans Bayer (H)

Dermatology Outpatient Office Hautmedizin Bad Soden, Bad Soden, Germany.

Marcus Heise (M)

Profile Centre of Health Sciences Halle, Faculty of Medicine, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany.
Institute for Health- and Nursing Science, Faculty of Medicine, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany.
Institute of General Practice and Family Medicine, Faculty of Medicine, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany.

Maurizio Podda (M)

Department of Dermatology, Medical Center Klinikum Darmstadt, Teaching Hospital Goethe-University Frankfurt, Darmstadt, Germany.

Uwe Kirschner (U)

Dermatology Outpatient Office Dr. Uwe Kirschner, Mainz, Germany.

Georgios Nikolakis (G)

Departments of Dermatology, Venereology, Allergology and Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane and Faculty of Health Sciences Brandenburg, Dessau, Germany.

Classifications MeSH