UPLIZNA is the first and only EC-approved monotherapy to target CD19+ B cells in adult patients with AQP4-IgG+ neuromyelitis optica spectrum disorder (NMOSD)1-4

MECHANISM OF ACTION

UPLIZNA is a targeted B-cell-depleting monotherapy intelligently designed for optimised efficacy and tolerability.1,5-7

Uplizna

AFUCOSYLATED
DESIGN

Enables efficient binding of effector cells, which allows for enhanced B-cell depletion at a low dose.9,10

  • Significant B-cell depletion vs placebo in 8 days with results maintained over 4+ years1,8
  • 89% of UPLIZNA-treated AQP4-IgG+ patients remained relapse-free for 28 weeks of treatment, with persisting relapse risk reduction for more than 4 years1,8

HUMANISED
STRUCTURE

Designed to improve tolerability and decrease immunogenicity.5-7

  • Low infusion-related reactions similar to placebo (9% UPLIZNA vs 10% placebo) in randomised controlled period5
  • Low rates of treatment-emergent anti-UPLIZNA antibodies (7.1%)1
  • Similar adverse-event rate compared to placebo1,5

SELECTIVELY
TARGETS CD19

Depletes the broad range of B cells central to NMOSD pathogenesis, including plasmablasts and plasma cells.1,11,12

  • Simple, twice-yearly dosing schedule after initial dose1
  • Monotherapy1

UPLIZNA IS A B-CELL-DEPLETING MONOTHERAPY INTELLIGENTLY
DESIGNED FOR OPTIMISED EFFICACY AND TOLERABILITY1,5-7

Following cell surface binding to CD19+ B lymphocytes, UPLIZNA results in antibody-dependent cellular cytolysis1

Targeting CD19 offers a therapeutic strategy that addresses a pathogenic driver central to NMOSD

Learn more about CD19 as a target

AQP4-IgG+: aquaporin-4 immunoglobulin G seropositive; CD19: Cluster of Differentiation 19; NMOSD: neuromyelitis optica spectrum disorder.

N-MOmentum Study

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Support & Resources

Pre- and during-UPLIZNA treatment information

What you need to know

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Summary of Product Characteristics

  1. UPLIZNA Summary of Product Characteristics.
  2. Horizon Therapeutics plc receives European Commission (EC) approval of UPLIZNA® (inebilizumab) for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD). News release. Horizon Therapeutics plc. May 2, 2022. Accessed May 4, 2022. https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-receives-european-commission-ec
  3. ENSPRYNG Summary of Product Characteristics.
  4. SOLIRIS Summary of Product Characteristics.
  5. 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.
  6. Hwang WYK, Foote J. Immunogenicity of engineered antibodies. Methods. 2005;36(1):3-10.
  7. Harding FA, Stickler MM, Razo J, et al. The immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regions. mAbs. 2010;2(3):256-265.
  8. 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.
  9. Herbst R, Wang Y, Gallagher S, et al. B- cell depletion in vitro and in vivo with an afucosylated anti-CD19 antibody [published correction appears in J Pharmacol Exp Ther. 2011 Jan;336(1):294. Dall’Aqua, William [corrected to Dall’Acqua, William]. J Pharmacol Exp Ther. 2010;335(1): 213-222. doi:10.1124/j pet.110.168062.
  10. Ward E, Mittereder N, Kuta E, et al. A glycoengineered anti-CD19 antibody with potent antibody-dependent cellular cytotoxicity activity in vitro and lymphoma growth inhibition in vivo. Br J Haematol. 2011;155(4):426-437.
  11. Forsthuber TG, Cimbora DM, Ratchford JN, et al. B cell-based therapies in CNS autoimmunity: differentiating CD19 and CD20 as therapeutic targets. Ther Adv Neurol Disord. 2018;11:1-13. doi:10.1177/1756286418761697.
  12. Bennett JL, O’Connor KC, Bar-Or A, et al. B lymphocytes in neuromyelitis optica. Neurol Neuroimmunol Neuroinflamm. 2015;2(3):e104. doi:10.1212/ NXI.0000000000000104.