Background Treatment options for chronic pulmonary sarcoidosis are limited in efficacy and by tolerability concerns. Namilumab, an investigational humanized monoclonal antibody inhibiting granulocyte macrophage colony-stimulating factor, was hypothesized to downregulate the granulomatous response in pulmonary sarcoidosis. Methods RESOLVE-Lung was a double-blind, placebo-controlled trial in participants with chronic active pulmonary sarcoidosis on oral corticosteroids (OCS) and/or immunosuppressive therapies (ISTs). Participants were randomized (1:1) to receive 150 mg namilumab or placebo via subcutaneous injection every 4 weeks and were required to stop ISTs and/or taper OCS. Endpoints were assessed at week 26. Primary endpoint was proportion of participants with a rescue event, such as disease worsening necessitating treatment. Secondary endpoints included safety, lung function assessments, and corticosteroid burden. Trial registration: NCT05314517 . Findings Of 209 participants screened, 107 were randomized to receive namilumab (n=53) or placebo (n=54). Proportion of participants with a rescue event was higher for the namilumab group (37·5%) compared with the placebo group (23·5%); stratified difference of 13·6% (90% CI: −1·5 to 28·7; p=0·12). LS mean change from baseline in ppFVC was −3·3% (90% CI: −5.1 to −1.5) for namilumab and −2·9% (90% CI: −4.5 to −1.3) for placebo (LS mean difference: −0·4%, 90% CI: −2·7 to 2·0). Proportion of participants successfully achieving OCS taper was 53·3% for namilumab and 76·9% for placebo (difference −19·4% 90% CI: −47·5 to 8·7). Treatment-emergent adverse events were reported in 94% in both groups, most being mild or moderate in severity. Interpretation In participants with chronic active pulmonary sarcoidosis, namilumab did not provide clinical benefit. Funding Kinevant Sciences GmbH.
Blink et al. (Thu,) studied this question.