Frequently Asked Questions

NMOSD (historically known as Devic’s disease) is a rare autoimmune disease involving axonal demyelination which is characterized by repeat attacks and accumulating, often permanent disability. In the United States, it affects ~16,000 to ~17,000 people. NMOSD is most prevalent in women and African and Asian populations.^1-6 Explore the demographics of NMOSD

Devastating attacks in NMOSD often lead to permanent disability, including blindness and paralysis. In one study of 175 patients with NMOSD, 67% of patients with optic neuritis and 83% of patients with transverse myelitis had little or no recovery.^3,4,6 See how NMOSD can cause permanent disability

While NMOSD and multiple sclerosis (MS) do share certain clinical presentations and symptoms, NMOSD can be differentiated from MS through MRI distinction, certain symptomatology, and aquaporin-4 immunoglobulin (AQP4-IgG) testing.^3,6-12 See similarities and differences between MS and NMOSD

AQP4-IgG antibodies are present in up to 90% of patients with NMOSD. Among available tests, serum cell-based assays are the most sensitive method of detecting aquaporin-4 immunoglobulin (AQP4-IgG) antibodies.^6,10-12 Read more about cell-based assays in NMOSD

B cells play multiple roles in the immunopathogenesis of NMOSD, including stimulating T cells and secreting cytokines. However, a pivotal role is played by plasmablasts and plasma B cells, which are largely responsible for the production of aquaporin-4 immunoglobulin (AQP4-IgG), the primary pathogenic driver of NMOSD.^13-15 Explore the role of B cells in NMOSD

The precise mechanism by which UPLIZNA exerts its therapeutic effects in NMOSD is unknown. UPLIZNA is a B-cell depleter that binds to CD19. UPLIZNA eliminates plasmablasts and some plasma cells, a primary driver of NMOSD immunopathogenesis.^13-16 Learn more about the molecular attributes of UPLIZNA

N-MOmentum is the largest clinical trial in NMOSD to date (N=230). N-MOmentum was a phase 2/3, multicenter, double-blind, randomized (3:1) placebo-controlled trial with an open-label extension period.^16-20 Learn more about the study design of N-MOmentum

The N-MOmentum trial used NMOSD-specific 18-point attack criteria to ensure investigators captured any sign or symptom of a new attack, from the most subtle to the most severe.^17,21 Explore the attack adjudication process

UPLIZNA delivered significant reduction in attacks through the first 28 weeks of treatment in the randomized controlled period of N-MOmentum. In a post hoc analysis of patients who remained on UPLIZNA through the open-label period, attack rate reductions were sustained over time. Learn more about the primary endpoint

In a post hoc analysis of the open-label period of N-MOmentum, UPLIZNA demonstrated a reduction in annualized attack rate over 2.5+ years.²² Consider open-label treatment phase study limitations when interpreting results. The OLP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. During the OLP, a total of 42 patients (19.4%) discontinued, of which 5 patients (2.3%) discontinued due to adverse events. Explore long-term attack-risk reduction

In addition to protecting patients against NMOSD attacks, UPLIZNA has demonstrated statistically significant reductions in lowering the risk of worsening disability (as measured by EDSS) and inpatient hospitalizations.^16,21 The EDSS analysis included visits during an attack, with EDSS progression driven by the expected increase in EDSS at the time of attack. Therefore, these results should not be interpreted as impacting disability independent of attack reduction. Additionally, subjects were not followed up for the same amount of time, resulting in missing data which may have introduced biases into the analysis. Subjects with missing data are imputed as worsening. Consider open-label treatment phase study limitations when interpreting results. The OLP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. During the OLP, a total of 42 patients (19.4%) discontinued, of which 5 patients (2.3%) discontinued due to adverse events. Explore efficacy beyond attacks

Urinary tract infection and arthralgia were adverse events with an incidence of ≥10% and were seen more frequently with UPLIZNA than with placebo.¹⁶ Explore safety data

UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. In the 28-week RCP, rates of infusion reactions with UPLIZNA were 9% vs 10% with placebo. All infusion-related reactions in patients receiving UPLIZNA were Grades 1 or 2. A corticosteroid, an antihistamine, and an antipyretic are given 30 to 60 minutes prior to administration to reduce infusion reactions.^16,17,21 Explore safety data

No head-to-head trials have been conducted between UPLIZNA and rituximab or between UPLIZNA and any treatment that is currently approved for the treatment of NMOSD. The N-MOmentum trial did include 17 patients with prior rituximab experience, and a post hoc analysis was done to investigate outcomes in these patients.²³ Explore results in rituximab-experienced patients

UPLIZNA is infused twice yearly following two initial loading doses at Day 1 and Day 15 of treatment.¹⁶ Learn more about dosing

UPLIZNA is administered as an intravenous infusion. The recommended dosage includes a 300-mg infusion followed 2 weeks later by a second 300-mg infusion. Subsequent doses (starting 6 months from the first infusion) are a single 300-mg infusion every 6 months for chronic usage. A corticosteroid, an antihistamine, and an antipyretic are given 30 to 60 minutes prior to administration to reduce infusion reactions.^16,17 Learn more about administration

Horizon By Your Side is a patient support program for patients prescribed UPLIZNA. Patient Access Liaisons offer a wide array of patient-focused services to help with the logistics of starting treatment. Learn more about Horizon By Your Side