In the randomised controlled period, UPLIZNA
monotherapy significantly reduced neuromyelitis optica spectrum disorder (NMOSD) attacks1

89% of patients on UPLIZNA monotherapy were
attack-free over 197 days.1

UPLIZNA EFFICACY

Time to onset of adjudicated attack (AQP4-IgG+ patients)1

time to onset of adjudicated attack in the AQP4-IgG+ populationtime to onset of adjudicated attack in the AQP4-IgG+ populationtime to onset of adjudicated attack in the AQP4-IgG+ population

Adapted from UPLIZNA SmPC.1

UPLIZNA showed a less severe attack profile in the RCP vs placebo (29% vs 45% major attacks)2

Patients treated with UPLIZNA at any point during N-MOmentum showed sustained efficacy:
more than 8 out of 10 patients remained attack-free during 4+ years of treatment.3

Probability of remaining attack-free after initiation of UPLIZNA (AQP4-IgG+ patients)3

probability of AGp4-IgG+ patients remaining attack free after initiation of UPLIZNAprobability of AGp4-IgG+ patients remaining attack free after initiation of UPLIZNAprobability of AGp4-IgG+ patients remaining attack free after initiation of UPLIZNA

Adapted from Rensel M et al. 2021.3

83% of patients were attack-free during 4+ years of UPLIZNA treatment.3

In the randomised controlled period, UPLIZNA provided durable B-cell depletion.4

Median B-cell counts in AQP4-IgG+ patients (intention-to-treat population)4b

median b-cell counts in AGP4-IgG+ patientsmedian b-cell counts in AGP4-IgG+ patientsmedian b-cell counts in AGP4-IgG+ patients

Adapted from Cree BAC et al. 2019.4

  • B-cell depletion was significant vs placebo within 8 days of treatment initiation and remained significant for over 6 months.1,4

B-cell reductions remained significant through
the open-label period.3

UPLIZNA SAFETY

In the randomised controlled period, UPLIZNA demonstrated a safety and tolerability profile.1,4

Adverse events with an incidence of ≥5% with UPLIZNA vs placebo in AQP4-IgG+ patients during the randomised controlled period (RCP).4

adverse events within an incidence of more than 5% with UPLIZNA vs placebo in AQP4-IgG+ patients during the randomized-controlled periodadverse events within an incidence of more than 5% with UPLIZNA vs placebo in AQP4-IgG+ patients during the randomized-controlled periodadverse events within an incidence of more than 5% with UPLIZNA vs placebo in AQP4-IgG+ patients during the randomized-controlled period

Adapted from Cree BAC et al. 2019.4

Adverse Events:

  • Adverse events occurred in 73% of the AQP4-IgG+ patients receiving UPLIZNA and 71% of the patients receiving placebo.4
  • Most adverse events reported with UPLIZNA occurred at a similar frequency with placebo, including infusion-related reaction.4
  • Urinary tract infection, arthralgia, back pain, headache, fall, hypoaesthesia, cystitis, and eye pain were nominally more frequent with UPLIZNA.4
  • Low rates of treatment-emergent anti-UPLIZNA antibodies (3%).4

In the randomised controlled period, serious adverse events were reported in 4% of AQP4-IgG+ seropositive patients on UPLIZNA vs 10% for placebo.4

UPLIZNA had a similar adverse-event rate compared to placebo in the RCP.1,4

In patients treated with UPLIZNA at any point during N-MOmentum, infection rates did not increase over 4+ years of treatment.3

Treatment-emergent infection rates with UPLIZNA (intention-to-treat population)3

AQP4-IgG+ populationAQP4-IgG+ populationAQP4-IgG+ population

  • Most common treatment-emergent infections over 4+ years of observation included urinary tract infection (26.2%), nasopharyngitis (20.9%), upper respiratory tract infection (15.6%), influenza (8.9%), and bronchitis (6.7%)1
  • Serious infections were rare and did not increase over time3

Treatment-emergent infection rates did not increase over time.3

In patients treated with UPLIZNA at any point during N-MOmentum, lower IgG levels were not associated with increased infection risk over 4+ years of treatment.5

Infection status by lowest IgG titre with UPLIZNA (intention-to-treat population)5d

AQP4-IgG+ populationAQP4-IgG+ populationAQP4-IgG+ population

Adapted from Greenberg B et al. 2021.5

<5% of participants
experienced IgG levels
below 300 mg/dL.3
Lower IgG levels did not correspond
with increased infection risk.3

Treatment

Treatment checklist icon.Treatment-checklist-icon. Treatment checklist icon.Treatment-checklist-icon. Treatment checklist icon.Treatment-checklist-icon.

Support & Resources

Pre- and during-UPLIZNA treatment information

What you need to know

e-services-icon e-services-icon e-services-icon

Scientific e-Service

Stay up-to-date on UPLIZNA with the latest scientific news, updates, and materials on treating NMOSD

Sign up now

Summary of Product Characteristics

a Cox regression method, with placebo as the reference group.1

b For CD19+ B-cell counts, assays for CD20+ B cells are used because the presence of UPLIZNA interferes with the CD19+ B-cell assay.1

c SAEs occurring in the UPLIZNA and placebo groups were not identical.4

d Although the lowest categories of IgG levels reported among participants were not significantly correlated with infection risk, the rate of severe infections was low and may not have been sufficient to rule out correlation.5

  1. UPLIZNA Summary of Product Characteristics.
  2. Weinshenker BG, Wingerchuk D, Green A, et al. Diagnosis, severity, and recovery of attacks in the N-MOmentum study of inebilizumab in neuromyelitis optica spectrum disorder. Poster 358 presented at: The 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 11-13, 2019 in Stockholm, Sweden.
  3. Rensel M, Zabeti A, Mealy MA, et al. Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: analysis of aquaporin-4-IgG seropositive participants taking inebilizumab for ≥4 years in the N-MOmentum trial. In press.
  4. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised, placebo-controlled phase 2/3 trial. Lancet. 2019;394:1352-1363. doi:10.1016/S0140-6736(19)31817-3.
  5. Greenberg B, She D, Katz E, et al. Immunoglobulin kinetics and infection risk after long-term inebilizumab treatment for neuromyelitis optica spectrum disorder. Poster A-21-00372 presented at: The 7th Congress of the European Academy of Neurology (virtual); June 19-21, 2021.