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
; 238(6): 1092-1103, 2022.
Article
en En
| MEDLINE
| ID: mdl-35679831
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® 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® 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).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® 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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
Problema de salud:
1_doencas_nao_transmissiveis
Asunto principal:
Hidradenitis Supurativa
Tipo de estudio:
Clinical_trials
Aspecto:
Patient_preference
Límite:
Humans
Idioma:
En
Revista:
Dermatology
Asunto de la revista:
DERMATOLOGIA
Año:
2022
Tipo del documento:
Article
País de afiliación:
Alemania