Circulating C-reactive protein (CRP) levels may identify patients with chronic obstructive pulmonary disease (COPD) who are likely to respond to bone marrow-derived allogeneic mesenchymal stromal cells (remestemcel-L), a therapy that has previously shown to induce clinically meaningful improvements in pulmonary and functional outcomes in this patient population, according to study results published in Respiratory Research.
Researchers conducted a post hoc analysis of a study that evaluated the safety and efficacy of 4 monthly infusions of remestemcel-L vs placebo in 62 patients with COPD (ClinicialTrials.gov Identifier: NCT00683722). Patients were followed for 2 years in the original study. In this post hoc analysis, investigators re-evaluated lung function, exercise performance, patient-reported responses, and exacerbation frequency in subgroups stratified by CRP levels of ≥4 mgL (n=29) and <4 mg/L (n=33).
A total of 12 patients with CRP ≥4 mg/L and 18 patients with CRP <4 mg/L received remestemcel-L. In the group of patients with baseline CRP ≥4 mg/L, the researchers reported a trend towards CRP reductions over the first 6 months in the remestemcel-L-treated group relative to the placebo group. These reductions did not correlate with observed changes in forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), or 6-minute walk distance (6MWD) in the overall study.
Improvements were also noted in FEV1, FVC, and 6MWD in remestemcel-L-treated patients with baseline CRP levels ≥3 mg/dl. Similar improvements were seen in FVC in remestemcel-L-treated patients with baseline CRP levels ≥2 mg/dL. No change was found in the number of COPD exacerbations over 2 years between the remestemcel-L vs placebo groups stratified by CRP ≥4 mg/dL or <4 mg/dL.
Limitations of this study included its post hoc nature as well as the lack of data on other inflammatory markers.
The investigators concluded that their observation of “a trend for an association between highest CRP levels and degree of clinical response suggests that the inflammatory component of COPD may amplify potential beneficial immunomodulatory effects of remestemcel-L” in patients with COPD.
Disclosure: This research was supported by Mesoblast. Please see the original reference for a full list of authors’ disclosures.
Weiss DJ, Segal K, Casaburi R, Hayes J, Tashkin D. Effect of mesenchymal stromal cell infusions on lung function in COPD patients with high CRP levels. Respir Res. 2021;22(1):142. doi:10.1186/s12931-021-01734-8