Safety and efficacy of rituximab in neuromyelitis optica spectrum disorders (RIN-1 study): a multicentre, randomised, double-blind, placebo-controlled trial
This small RCT (n-38) found rituximab prevented relapses for 72 weeks in patients with neuromyelitis optica spectrum disorders who were AQP4 antibody-positive (7 [37%] relapses placebo vs 0 in rituximab group; p=0.0058) and should be investigated further as maintenance therapy.
Source:
The Lancet Neurology
SPS commentary:
According to an editorial, in clinical practice, rituximab now joins other new drugs available for neuromyelitis optica spectrum disorders (eculizumab, satralizumab, inebilizumab). It notes that the placebo-controlled N-MOmentum trial showed that the anti-CD19 monoclonal antibody inebilizumab, with broader depleting effects on lymphocytes of the B-cell lineage than rituximab, is effective too. It adds that comparison of placebo-controlled trials of B-cell depletion is difficult because the N-MOmentum study was designed as a pivotal (approval) trial with a much larger study population (230 randomised patients vs 38 patients in the RIN-1 study), was done in several countries (whereas recruitment for the RIN-1 study was solely in Japan), and applied neuromyelitis optica-specific relapse criteria, including a relapse adjudication process. Therefore, N-MOmentum is clearly the most convincing trial available to date showing high therapeutic efficacy of B-cell depletion strategies in neuromyelitis optica. The editorial suggests that taken together, the findings of the RIN-1 study provide an important step towards routine use of rituximab for this condition, but comparison of B-cell depletion strategies in future studies is warranted.