Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): a randomised, double-blinded, multicentre, phase 2 study
Makaleler > Tam Makale · 2026
Yazarlar: Bernt Van Den Blink, Surinder S. Birring, Nesrin MOĞULKOÇ BISHOP, Sibel Nayci Atis, Rohit Gupta, Julien Guiot, Simon P. Hart, Eva M. Carmona Porquera, Hajira B. Koeller, Natasha Arocho, Chantal M. Petit, Jill Denning, Min Lin, Robert P. Baughman, Marlies Wijsenbeek-Lourens, Theodore F. Reiss, on behalf of the RESOLVE-Lung investigators
European Respiratory Journal, Uluslararası, Scopus, 2026, cilt 68, ss 2501874-2501874
DOI: 10.1183/13993003.01874-2025
Özet
BACKGROUND: Treatment options for chronic pulmonary sarcoidosis are limited in efficacy and by tolerability concerns. Namilumab, an investigational humanised monoclonal antibody inhibiting granulocyte-macrophage colony-stimulating factor, was hypothesised to downregulate the granulomatous response in pulmonary sarcoidosis. METHODS: subcutaneous injection every 4 weeks and were required to stop IST and/or taper OCS. End-points were assessed at week 26. The primary end-point was the proportion of participants with a rescue event, such as disease worsening necessitating treatment. Secondary end-points included safety, lung function assessments and corticosteroid burden. The trial was registered at ClinicalTrials.gov (NCT05314517). RESULTS: Of 209 participants screened, 107 were randomised to receive namilumab (n=53) or placebo (n=54). The proportion of participants with a rescue event was higher for the namilumab group (37.5%) compared with the placebo group (23.5%) (stratified difference 13.6 (90% CI -1.5-28.7) percentage points; p=0.12). The least squares (LS) mean change from baseline in forced vital capacity % predicted was -3.3 (90% CI -5.1- -1.5) percentage points for namilumab and -2.9 (90% CI -4.5- -1.3) percentage points for placebo (LS mean difference -0.4 (90% CI -2.7-2.0) percentage points). The proportion of participants successfully achieving OCS taper was 53.3% for namilumab and 76.9% for placebo (difference -19.4 (90% CI -47.5-8.7) percentage points). Treatment-emergent adverse events were reported in 94% in both groups, most being mild or moderate in severity. CONCLUSION: In participants with chronic active pulmonary sarcoidosis, namilumab did not provide clinical benefit.