Rituximab with mycophenolate mofetil improves symptoms in ILD patients

In patients with interstitial lung disease (ILD) with an nonspecific interstitial pneumonia (NSIP) pattern, the combination of rituximab and mycophenolate mofetil (MMF) outperformed MMF alone, says an article published in European Respiratory Journal.

Mycophenolate mofetil is one of the first-line medications for interstitial lung disease with a nonspecific interstitial pneumonia pattern, and rituximab is utilized as rescue therapy. As a result, Julie Mankikian and colleagues undertook this trial to evaluate the effectiveness of rituximab with mycophenolate mofetil in patients with interstitial lung disease.

In this randomized, two-parallel group, double-blind, placebo-controlled trialPatients with connective tissue disease-associated interstitial lung disease (ILD) or idiopathic interstitial pneumonia (IIP) and an NSIP pattern (defined on NSIP pathological trends or on integration of clinico-biological data and an NSIP-like high-resolution computed tomography pattern) were randomly assigned in a 1:1 ratio to receive rituximab (1000 mg) or placebo on days 1 and 15 in addition to standard care. The major end-point measured by a linear mixed model for repeated measures analysis was the variation in percent predicted forced vital capacity (FVC) from baseline to six months. Safety and progression-free survival (PFS) for the first six months were secondary endpoints.

The key findings of this study were:

1. 122 randomly selected patients were given at least one dose of either rituximab (n = 63) or a placebo (n = 59) between January 2017 and January 2019.

2. The rituximab+MMF group's least-squares mean change in FVC (% predicted) from baseline to six months was 1.60 (se 1.13) while the placebo+MMF group's change was 2.01 (se 1.17).

3. In the rituximab+MMF group, PFS was better. 26 (41%) participants in the rituximab+MMF group and 23 (39%) patients in the placebo+MMF group experienced serious side events.

4. Five bacterial infections, three virus infections, and one other infection were recorded in the rituximab+MMF group's nine infections, while four bacterial infections were identified in the placebo+MMF group.

Reference:

Mankikian, J., Caille, A., Reynaud-Gaubert, M., Agier, M.-S., Bermudez, J., Bonniaud, P., Borie, R., Brillet, P.-Y., Cadranel, J., Court-Fortune, I., Crestani, B., Jouneau, S., Juvin, K., Leger, J., … Marchand-Adam, S. (2023). Rituximab and mycophenolate mofetil combination in patients with interstitial lung disease (EVER-ILD): a double-blind, randomised, placebo-controlled trial. In European Respiratory Journal (Vol. 61, Issue 6, p. 2202071). European Respiratory Society (ERS). https://doi.org/10.1183/13993003.02071-2022