Inebilizumab Treatment for Patients With NMOSD May Not Up COVID-19 Risk

The risk for COVID-19 was low among patients with NMOSD who received inebilizumab.

The incidence for COVID-19 is low among patients with neuromyelitis optica spectrum disorder (NMOSD) who receive inebilizumab treatment. Among those patients who were infected with COVID-19, favorable clinical outcomes were reported. These are the results of a study presented at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held from May 31 to June 3 in Aurora, Colorado.

Inebilizumab is an anti-CD19, B-cell depleting monoclonal antibody approved for the treatment of aquaporin-4 (AQP4) seropositive NMOSD. As a monoclonal antibody targeting agent, serum immunoglobulin and B-cell levels typically decrease over time; however, individuals on long-term treatment typically do not show an increased risk for infections.

For the study, researchers aimed to evaluate outcomes of individuals with NMOSD, treated with inebilizumab who were infected with COVID-19.

In the N-MOmemtum clinical trial (ClinicalTrials.gov Identifier: NCT02200770), the researchers analyzed adverse events of COVID-19 infections in patients with NMOSD who received inebilizumab in the United States from March 2020 to November 2022.

In a 28-month period, a low incidence of COVID-19 infections was reported in patients with NMOSD receiving inebilizumab in the trial and in clinical settings in the United States.

Of the 182 patients who participated in N-MOmentum, there were a total of 17 confirmed reports of COVID-19 (women, n=15; unknown, n=2; median age, 57), with 2 infections occurring prior to vaccine availability. The average inebilizumab exposure was 123 days (range, 10-2379; n=11), from initial infusion to COVID-19 diagnosis.

A total of 10 out of 17 events were reported as serious, with 6 reported as “recovered/resolved”, 2 as “not recovered/resolved”, and 2 deaths. COVID-19 vaccination status was unknown.

Of the 2 deaths, 1 Peru resident, age 62, died prior to vaccine availability in May 2020, with possible COVID pneumonia and renal failure, treated with antibiotics, hydroxychloroquine and ivermectin. The second patient, a possible partially vaccinated US resident, age 32, with a history of obesity, deep vein thromboembolism, and sickle cell trait, died in February 2021, and was treated for possible COVID pneumonia complicated by pulmonary embolism with acute for pulmonate.

Limitations of the study included underreporting of milder COVID cases.

The researchers concluded that “In a 28-month period, a low incidence of COVID-19 infections was reported in patients with NMOSD receiving inebilizumab in the trial and in clinical settings in the United States.”

References:

Cree B, Rensel M, Pittock S, et al. Clinical outcomes of COVID-19 infection among patients with neuromyelitis optica spectrum disorder receiving inebilizumab treatment. Abstract presented at: CMSC 2023; May 31-June 3, 2023; Aurora, CO. Abstract NID08.