Uplizna Found Effective at Reducing Attacks, Disability in EU Patients
Uplizna (inebilizumab-cdon) was found effective both at reducing attacks and lessening disability in people with neuromyelitis optica spectrum disorder (NMOSD) living in Europe, according to data from the N-MOmentum Phase 2/3 trial.
Nearly 90% of participants given Uplizna remained free from attacks six months after starting the therapy, the data showed.
These new data were presented in a poster, titled “Efficacy of inebilizumab in the European Union subpopulation of the N-MOmentum trial,” at the 8th Congress of the European Academy of Neurology, held June 25–28 in Vienna, Austria (poster EPO-148).
“We believe these data provide treating physicians with greater certainty that a targeted monotherapy like Uplizna can be a valuable option for the treatment of NMOSD patients in Europe,” Karl Boegl, MD, PhD, executive director and regional medical affairs lead at Horizon Therapeutics, the company marketing Uplizna, said in a press release.
Uplizna is approved in the EU and the U.S. to treat adult NMOSD patients positive for antibodies against the aquaporin-4 protein (AQP4). The therapy was designed to kill B-cells, the immune cells responsible for making antibodies, by targeting a protein called CD-19.
“With Uplizna, physicians have a treatment option that can be given twice a year after initial dosing to help prevent NMOSD attacks by specifically targeting CD19 B-cells, which play a central role in the pathogenesis [processes] of the disease,” said Friedemann Paul, MD, from the Max Delbrück Center for Molecular Medicine and Charité–Universitätsmedizin Berlin, in Germany, who presented the poster.
Data from N-MOmentum (NCT02200770), in which 230 people with NMOSD were randomly assigned to receive Uplizna or a placebo, supported the therapy’s approval.
The trial’s results showed that nearly nine in 10 patients given Uplizna were attack-free after 28 weeks (more than six months), and the vast majority remained free from attacks for up to four years.
“The Uplizna pivotal trial is the largest in NMOSD and clearly demonstrates the merits of targeting CD19 B-cells, including plasmablasts and plasma cells, to provide broad, deep and durable B-cell depletion,” said Boegl.
The new analysis compared the safety, attack rates, and disability-related outcomes of 50 trial participants living in the European Union relative to 163 non-EU patients. The European patients included people from Bulgaria, Czech Republic, Estonia, Germany, Hungary, and Poland.
The findings showed that Uplizna-treated patients experienced significantly fewer attacks compared with those given a placebo — 12.5% vs. 30%. These results were in agreement with those from non-EU patients treated with Uplizna, who experienced a lower attack rate (10.7%) compared with those on the placebo (45.2%).
Also, the number of NMOSD-related hospitalizations in EU patients was reduced in those given Uplizna relative to the placebo group, with a mean of one versus two hospitalizations. Similar results had been seen in non-EU patients — a mean of one hospitalization with Uplizna compared with 1.33 among those given the placebo.
In addition, a numerical difference favoring Uplizna in EU patients was reported for the number of active lesions detected in MRI scans, with a mean of 1.11 compared with 1.33 for those on the placebo.
However, in both cases — for NMOSD-related hospitalizations and active lesions — the differences did not reach statistical significance.
Results further showed no difference in disability worsening between Uplizna-treated EU patients (15%) compared with those not from Europe (14.9%), as assessed with the Expanded Disability Status Scale.
Overall, Uplizna “was associated with reduced risk of NMOSD attacks and disability in EU and non-EU cohorts [groups] of N-MOmentum,” the team concluded.