CO6 - Antibiotic Therapy for the Cutibacterium acnes–associated phenotype in sarcoidosis: a randomized controlled trial
Montse Janssen Bonas (Netherlands)1; R. Kraaijvanger (Netherlands)1; C.A. Ambarus (Netherlands)2; R.G.M. Keijsers (Netherlands)3; A.F. van den Hoven (Netherlands)3; J.C. Grutters (Netherlands)1 4; M. Veltkamp (Netherlands)1 4;
1 - 1. ILD Center of Excellence, member of European Reference Network-Lung, St Antonius Hospital, Nieuwegein, the Netherlands; 2 - 2. Pathologie DNA, Department of Pathology, St Antonius Hospital, Nieuwegein, the Netherlands; 3 - 3. Department of Nuclear Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands; 4 - 4. Division of Heart & Lungs, Utrecht University Medical Center, Utrecht, the Netherlands;
Keywords: Phenotypes; Treatable trait; Antibiotics;
Select the theme: Controversies in Sarcoidosis Treatment
Type: Original Papers
Presentation: Oral Communication

Introduction: Sarcoidosis is an idiopathic, systemic inflammatory disorder that predominantly affects the lungs and lymph nodes. Presence of Cutibacterium acnes has been identified in various granulomatous diseases, including sarcoidosis, hypersensitivity pneumonitis, and vasculitis. Its known mitogenic capacity, together with evidence associating its presence with a more progressive disease course in sarcoidosis, support the hypothesis that it may represent a treatable trait in a subset of patients.

Objectives: To investigate whether combined treatment with azithromycin and doxycycline reduces inflammatory activity in patients with sarcoidosis patients in whom Cutibacterium acnes was detected in biopsy tissue.

Materials and Methods: A total of 40 treatment-naive patients with biopsy-confirmed, active sarcoidosis and no current indication for therapy were stratified according to the presence or absence of Cutibacterium acnes in biopsy tissue. Following stratification, patients were randomized (1:1) to receive doxycycline plus azithromycin or placebo for 3 months. Inflammatory activity was assessed using 2-[18F]FDG-PET/CT imaging. The primary endpoint was the percentage of change in SUVmax from baseline to 3 months.

Results: All 40 patients have been enrolled. The final patient is expected to complete the 3-month treatment period in the first week of May 2026. Database lock will subsequently follow, with primary endpoint results anticipated in early June 2026.

Conclusions: This is the first randomized controlled trial to evaluate whether the presence of Cutibacterium acnes constitutes a treatable trait in sarcoidosis. Results from this study will provide novel insights into phenotype-driven therapeutic strategies. We aim to present the findings at the upcoming WASOG conference in Porto.