Inebilizumab (1) – Uplizna®

• Clinical trials
  • The N-MOmentum study is a Phase II/III, double-blind, multicentre RCT conducted to support marketing authorisation, comparing inebilizumab with placebo, which included adults with AQP4-IgG-seropositive NMOSD who had experienced at least one acute relapse in the previous year or at least two relapses within the last two years, for which emergency treatment was required.
  • The SAkuraStar study is a pivotal, double-blind, multicentre Phase III RCT followed by an open-label extension phase to compare satralizumab with placebo, which enrolled adults with AQP4-IgG-seropositive or -seronegative NMOSD who had experienced at least one relapse in the previous year.

Adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive

• For adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive, the additional benefit is not proven.
• No data relevant to the benefit assessment of inebilizumab are available; consequently, additional benefit is not proven.
• In the absence of direct comparative studies, the pharmaceutical manufacturer has submitted an adjusted indirect comparison with satralizumab via the bridge comparator placebo for the benefit assessment.
• The adjusted indirect comparison with satralizumab as the sole comparator, as presented, is deemed unsuitable for establishing additional benefit over treatment as prescribed by a doctor.

Courtesy translation only, please refer to the German original.