Efficacy Beyond Attacks

UPLIZNA reduced NMOSD-related hospitalizations1

Severe infection rates among patients treated with UPLIZNA were rare and did not increase over time2a

NMOSD patient, Betsy

Rate of hospitalization in AQP4-IgG+ patients1

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

aIn the RCP.

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  • Hospitalizations remained low for patients randomized to UPLIZNA (15.6%, n=201) throughout the 4+ year open-label period3

UPLIZNA provides protection against markers of worsening disease3

UPLIZNA significantly reduced the risk of disability accrual as measured by EDSS (P=.0047), including visual function, bowel and bladder dysfunction, balance, and sensory functions2
Percentage of AQP4-IgG+ patients with worsening disability from baseline3a

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

aIn the RCP.

Rapid, significant, and sustained B-cell depletion4,5

With UPLIZNA, B-cell depletion was significant at 8 days and all time points (P<.0001)3
Median B-cell counts in AQP4-IgG+ patients4b

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

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

Patients on UPLIZNA sustained B-cell depletion over 4+ years3
Median B-cell counts in AQP4-IgG+ patients3b

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

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

Common Fc gamma mutations did not impact the efficacy of UPLIZNA5
  • Approximately 40% of Caucasians and African Americans have an Fc gamma receptor genotype that results in reduced IgG binding and diminished efficacy of some monoclonal antibodies, including rituximab5
  • The glycoengineered design of UPLIZNA ensures that even patients with Fc gamma mutations will experience efficient B-cell depletion5

Due to its glycoengineered design, efficacy with UPLIZNA was consistent in patients with and without Fc gamma mutations through 4+ years4

Jasmine is an actual patient. Individual results may vary.

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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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Review UPLIZNA’s safety profile

AQP4, aquaporin-4; IgG+, immunoglobulin G positive; EDSS, expanded disability status scale; Gd, gadolinium; NMOSD, neuromyelitis optica spectrum disorder; RCP, randomized controlled period.

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. UPLIZNA (inebilizumab-cdon) [prescribing information]. Horizon.
  2. Rensel M, Zabeti A, Mealy M, et al. Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: analysis of aquaporin-4–immunoglobulin G–seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial. Mult Scler. 2022;28(6):925-932. doi:10.1177/13524585211047223
  3. Data on File. Horizon, June 2020.
  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(10206):1352-1363. doi:10.1016/S0140-6736(19)31817-3
  5. Aktas O, Bennett JL, Weinshenker BG, et al. Impact of low affinity IgG Fc region receptor III-A gene polymorphisms on neuromyelitis optica spectrum disorder treatment outcomes: N-MOmentum study. Poster NDM02 presented at: 16th World Congress on Controversies in Neurology (virtual); March 24-27, 2022.