Good long-term safety and efficacy of inebilizumab in NMOSD

In patients with neuromyelitis optica spectrum disorder (NMOSD), inebilizumab continued to be efficacious, with up to 77% of patients free of attacks for at least 4 years, and no additional safety concerns. This was concluded from interim analyses of the open-label extension of the randomised N-MOmentum trial, presented in 2 abstracts.

The placebo-controlled N-MOmentum study (NCT02200770) evaluated efficacy and safety of inebilizumab in patients with NMOSD. After 28 weeks, inebilizumab was well tolerated, decreased the risk of an NMOSD attack, and decreased disability worsening [1]. After the randomised controlled period, participants could enter the open-label extension period (OLE) for a minimum of 2 years. Prof. Bruce Cree (University of California San Francisco, CA, USA) presented interim efficacy and safety analyses of the OLE [2,3].

OLE participants received inebilizumab 300 mg every 28 weeks. For analysis, 4 groups of participants were distinguished:

• INE/INE: participants who received inebilizumab during the randomised controlled period and the OLE;
• PBO/INE: participants who received placebo during the randomised controlled period, inebilizumab during the OLE;
• Any INE: all participants who received inebilizumab at some point during the study;
• Long-term INE: participants who received inebilizumab ≥4 years.

In total, 51/56 (91.1%) of those originally randomised to placebo and 165/174 (94.8%) of those originally randomised to inebilizumab entered the OLE. Mean exposure was 3.2 years.

Regarding efficacy, attack risk was reduced in all patients who were treated with inebilizumab. Annualised attack rate (AAR) decreased with long-term treatment. In total, 77.1% of the 'Any INE' group remained free of attacks for at least 4 years. Benefits in terms of disability and of NMOSD-related rates of hospitalisation were sustained in the OLE, as were radiological benefits.

Long-term inebilizumab treatment was generally well tolerated. Overall treatment-emergent adverse event (AE) rate in the INE/INE, PBO/INE, and 'Any INE' group was 1.54, 1.55, and 0.28, respectively. Rates of AEs of special interest did not increase during the OLE. Immunoglobulin levels decreased with long-term treatment, but were not associated with increased infection risk. Rates of infection or serious infection did not increase.

1. Cree BAC, et al. Lancet. 2019 Oct 12;394(10206):1352–63.
2. Cree BAC, et al. Long term efficacy outcomes with inebilizumab treatment in neuromyelitis optica spectrum disorder: the N-MOmentum trial. OPR-161, EAN 2021 Virtual Congress, 19–22 June.
3. Cree BAC, et al. Long term safety outcomes with inebilizumab treatment in neuromyelitis optica spectrum disorder: the N-MOmentum trial. OPR-160, EAN 2021 Virtual Congress, 19–22 June.

 

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Posted on 18 August, 202116 February, 2024