#AAN2022 – Uplizna Effective in Newly Diagnosed Patients: Analysis

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by Steve Bryson PhD |

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Uplizna in newly diagnosed patients | Neuromyelitis News | clinical trial graphs illustration

Uplizna (inebilizumab-cdon) was just as safe and effective in people with neuromyelitis optica spectrum disorder (NMOSD) treated after only one symptomatic attack as those treated after two or more attacks, according to an analysis of N-MOmentum Phase 2/3 trial data.

This sub-analysis had sought to understand how a prior history of attacks might affect Uplizna’s response by examining its benefits at disease onset compared with its effects among patients who had experienced two or more attacks before the study began.

These new data are being presented as a poster at the American Academy of Neurology (AAN) 2022 Annual Meeting in Seattle, held in-person April 2-7 and virtually April 24-26.

“These data are important because physicians see NMOSD patients at varying stages of their illness and it is helpful to understand how Uplizna might benefit patients at disease onset as well as those who have had more than one attack,” Bruce Cree, MD, PhD, a professor at the University of California San Francisco Weill Institute for Neurosciences and primary study investigator, said in a press release.

“With this information,” added Cree, “physicians can feel confident that patients may stop experiencing attacks after being treated with Uplizna regardless of how many previous attacks they experienced.”

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Analysis: Uplizna Provides Long-term NMOSD Attack Prevention

Uplizna is approved in the U.S. to treat adults who test positive for antibodies against the aquaporin-4 protein (AQP4), the most common target of NMOSD-related antibodies. The therapy is designed to deplete immune B-cells that generate these antibodies, intending to reduce inflammation and nerve damage involving the optic nerve, spinal cord, and brain.

In the 28-week Phase 2/3 N-MOmentum study (NCT02200770) that supported Uplizna’s approval, 89% of those assigned the therapy remained attack-free. That compared to 58% of those who received a placebo, the initial trial data showed. A more recent exploration of that data also showed that Uplizna reduced the severity of attacks in trial participants who continued to experience attacks after being treated.

This new investigation found that, among the 37 participants who experienced only one attack before joining the study, 4.2% of Uplizna-treated patients — in fact, one patient of 24 — reported an attack versus 23.1% of the placebo group. In comparison, of the 176 participants who had experienced two or more pre-study attacks, 12.4% of treated individuals had an attack compared with 48.7% — three of 13 patients — given the placebo.

There was no difference in attack worsening or disability between the two groups, as assessed with the Expanded Disability Status Scale (EDSS). Treatment-emergent adverse events from Uplizna among patients enrolled after their first attack was similar to overall trial outcomes.

Previously reported trial data showed Uplizna treatment reduced pain — a common, debilitating symptom of NMOSD that can impair daily activities.

Additional exploration of study results being presented separately at the AAN meeting builds on those findings by demonstrating sustained, long-term benefits in managing pain, as assessed by the 36-item short-form survey body pain subscore (SF36-BPS).

There were year-over-year improvements in pain scores from pre-treatment to an average of 6.57 points after one year, 7.08 points after two years, and 7.96 points after three years of treatment.

“These rigorous analyses from the Uplizna pivotal trial provide compelling insights into the real value that Uplizna may provide as a novel option for people living with NMOSD,” said Kristina Patterson, MD, PhD, medical director of neuroimmunology at Horizon Therapeutics, the company that markets the therapy.

“As physicians gain more experience with Uplizna, they can see how these clinical data translate into outcomes within their practices and potentially help more patients gain greater control over this challenging disease,” Patterson added.