Evidence map›Paper›PMID 35679831›Full record

Trial reportDermatology (Basel, Switzerland)2022

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.

Michael Schultheis, Petra Staubach, Stephan Grabbe, Christian Ruckes, Esther von Stebut, Uwe Kirschner, Łukasz Matusiak, Jacek C Szepietowski, Georgios Nikolakis

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Dermatology (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Michael SchultheisDepartment of Dermatology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.
Petra StaubachDepartment of Dermatology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.
Stephan GrabbeDepartment of Dermatology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.
Christian RuckesInterdisciplinary Centre for Clinical Studies, University Medical Center, Johannes Gutenberg University, Mainz, Germany.
Esther von StebutDepartment of Dermatology, Faculty of Medicine, University of Cologne, Cologne, Germany.
Uwe KirschnerDermatology Outpatient Office Dr. Uwe Kirschner, Mainz, Germany.
Łukasz MatusiakDepartment of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.
Jacek C SzepietowskiDepartment of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.
Georgios NikolakisDepartments of Dermatology, Venereology, Allergology and Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane and Faculty of Health Sciences Brandenburg, Dessau, Germany.

Funding

Austrian Science Fund FWF I 4229
6 · The paper itself

Abstract

backgroundHidradenitis 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® therapy can sustain or even increase remission after a first topical antibiotic treatment cycle.

methodsThe 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® 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® therapy for an additional 16 weeks (8 sessions, group TC + L/L and group TC/L).

resultsIn 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.

conclusionLAight® 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® 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.

Indexed as

Hidradenitis SuppurativaAnti-Bacterial AgentsClindamycinHumansSeverity of Illness IndexTreatment OutcomeAnti-Bacterial AgentsClindamycinHidradenitis suppurativaLAight®Noninvasive deviceTopical treatment

Identifiers

PMID35679831
PMCPMC9808664

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.