Universität zu Köln

Schultheis, Michael, Staubach, Petra, Grabbe, Stephan, Ruckes, Christian, von Stebut, Esther, Kirschner, Uwe, Matusiak, Lukasz, Szepietowski, Jacek C. and Nikolakis, Georgios (2022). LAight (R) 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, 238 (6). S. 1092 - 1104. BASEL: KARGER. ISSN 1421-9832

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Abstract

Background: Hidradenitis suppurativa is a chronic, inflammatory, burdensome skin disease where current first-line treatments are limited to topical and/or systemic antibiotics which cannot be applied for long-term disease management. Period B of the RELIEVE study analyzes whether LAight (R) therapy can sustain or even increase remission after a first topical antibiotic treatment cycle. Methods: The RELIEVE study was performed as a two-period multicenter randomized controlled trial with blinded assessment. For period A from week 0 to week 16, the 88 participating Hurley I and II patients were randomized to either a group receiving topical clindamycin 1% solution combined with 8 additional bi-weekly treatments with LAight (R) therapy (group TC + L) or a group which was treated with topical clindamycin 1% solution only (group TC). After 16 weeks, patients entered open-label period B and both groups were treated exclusively with LAight (R) therapy for an additional 16 weeks (8 sessions, group TC + L/L and group TC/L). Results: In total, 88 patients were enrolled in RELIEVE. Seventy-eight patients entered period B; 39 belonged to group TC + L/L and 39 to group TC/L. The IHS4-response at the start of period B was 62% (group TC + L/L) and 33% (group TC + L). During the 16 weeks of additional monotherapy with LAight, in both groups > 90% of patients who responded to therapy in period A maintained their IHS4-response at week 32. IHS4 response rates continued to rise up to 79% of the TC + L/L group and up to 71% of the TC/L group during period B at week 32. Achievement of HiSCR and certain patient reported outcomes confirmed primary endpoint results. Conclusion: LAight (R) therapy is an effective approved therapy option for Hurley I and II HS that can be used continuously to maintain treatment success. During 16 weeks of follow-up in period B, over 90% of patients with response after period A maintained their treatment outcome, while more than 60% of prior nonresponders gained response. The fact that LAight (R) therapy can be applied continuously, is very effective and is well tolerated makes it a valuable treatment tool in the design of HS long-term treatment modalities. (C) 2022 The Author(s).Published by S. Karger AG, Basel

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schultheis, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Staubach, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Grabbe, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruckes, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED von Stebut, Esther UNSPECIFIED UNSPECIFIED UNSPECIFIED Kirschner, Uwe UNSPECIFIED UNSPECIFIED UNSPECIFIED Matusiak, Lukasz UNSPECIFIED UNSPECIFIED UNSPECIFIED Szepietowski, Jacek C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nikolakis, Georgios UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-682551
DOI:	10.1159/000524739
Journal or Publication Title:	Dermatology
Volume:	238
Number:	6
Page Range:	S. 1092 - 1104
Date:	2022
Publisher:	KARGER
Place of Publication:	BASEL
ISSN:	1421-9832
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CLINDAMYCIN; COMBINATION; ADALIMUMAB; VALIDATION; RIFAMPICIN Multiple languages Dermatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/68255