Efficacy Beyond Attacks

UPLIZNA reduced NMOSD-related hospitalizations1

UPLIZNA protected patients from inpatient hospitalization stays1,2a

NMOSD patient, Betsy

NMOSD patient, Betsy

Reduction in Hospitalizations
Reduction in Worsening Disability
B-Cell Depletion

Reduction in Hospitalizations
Annualized rate of hospitalization in AQP4-IgG+ patients1,2

Chart showing rate of hospitalization in AQP4-IgG+ patients in UPLIZNA and Placebo groups, with a 78% relative risk reduction in the RCPChart showing rate of hospitalization in AQP4-IgG+ patients in UPLIZNA and Placebo groups, with a 78% relative risk reduction in the RCP

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  • Hospitalizations remained low for AQP4-IgG+ patients randomized to UPLIZNA (15.6%, n=24/154) throughout the open-label period1

Reduction in Worsening Disability

UPLIZNA provides protection against markers of worsening disease1

UPLIZNA significantly reduced the risk of disability accrual as measured by EDSS (P = 0.0047), including visual function, bowel and bladder dysfunction, balance, and sensory functions1
Percentage of AQP4-IgG+ patients with worsening disability from baseline1a

Chart showing percentage of AQP4-IgG+ patients with worsening disability from baseline in UPLIZNA and Placebo groups, with a 57% relative risk reduction in the RCPChart showing percentage of AQP4-IgG+ patients with worsening disability from baseline in UPLIZNA and Placebo groups, with a 57% relative risk reduction in the RCP

UPLIZNA provided rapid and sustained B-cell depletion2-4

B-Cell Depletion
RCP: Median B-cell counts in ITT
population3b

With UPLIZNA, B-cell depletion was significant at 8 days and all time points (P < 0.0001)3

RCP: Median B-cell counts in ITT population3b

Chart showing UPLIZNA efficacy through B-cell depletion at 197 days, with CD20 B cells at 0 for UPLIZNA and roughly 150 cells per microliter in Placebo

Chart showing UPLIZNA efficacy through B-cell depletion at 197 days, with CD20 B cells at 0 for UPLIZNA and roughly 150 cells per microliter in Placebo

  • UPLIZNA provided rapid and sustained plasmablast/plasma cell depletion4
  • At the end of the RCP, twice as many patients taking UPLIZNA had a ≥ twofold decrease in AQP4-IgG
    vs placebo (37% vs 18%)4
OLP: Median B-cell counts in AQP4-
IgG+ patients1b

Patients on UPLIZNA sustained B-cell depletion over 4+ years1

Median B-cell counts in AQP4-IgG+ patients1b

Chart showing median B-cell counts in AQP4-IgG+ patients, with sustained B-cell depletion over 4+ years for UPLIZNA patients

Chart showing median B-cell counts in AQP4-IgG+ patients, with sustained B-cell depletion over 4+ years for UPLIZNA patients

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Twice-Yearly Dosing With UPLIZNA

UPLIZNA is the only approved monotherapy for NMOSD with a twice-yearly dosing schedule after 2 initial start-up doses.

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aIn the RCP.

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

AQP4-IgG+, aquaporin-4-immunoglobulin G positive; EDSS, Expanded Disability Status Scale; Gd, gadolinium; ITT, intention-to-treat; NMOSD, neuromyelitis optica spectrum disorder; RCP, randomized controlled period.

Tx Recommendations

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

  • A history of life-threatening infusion reaction to UPLIZNA
  • Active hepatitis B infection
  • Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

  • A history of life-threatening infusion reaction to UPLIZNA
  • Active hepatitis B infection
  • Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

  1. Data on File. Horizon. June 2020.
  2. UPLIZNA (inebilizumab) [prescribing information] Horizon.
  3. Cree BAC, Bennett JL, Kim HJ, et al. N-MOmentum study investigators. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised, placebo-controlled phase 2/3 trial. Lancet. 2019;394(10206):1352-1363. doi:10.1016/S0140-6736(19)31817-3
  4. Bennett JL, Aktas O, Rees WA, et al. Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: an exploratory analysis from N-MOmentum, a double-blind, randomised, placebo controlled, multicentre phase 2/3 trial. Lancet. 2022;86(104321):1-19. doi:10.1016/j.ebiom.2022.104321
  5. Pittock S, Paul F, Kim HG, et al. Association of b cell subsets and aquaporin-4 antibody titers with disease activity in participants in the N-MOmentum trial receiving inebilizumab treatment. Poster P011 presented at: 38th Congress of ECTRIMS; October 26-28, 2022