Efficacy Beyond Attacks

UPLIZNA reduced NMOSD-related hospitalizations1

UPLIZNA protected patients from inpatient hospitalization stays1,2

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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  • 15.6% (24/154) of AQP4-IgG+ patients randomized to UPLIZNA were hospitalized throughout the 2+ year open-label period1a

aConsider 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.

Reduction in Worsening Disability

UPLIZNA provided protection against markers of worsening disease1

UPLIZNA significantly reduced the risk of disability accrual as measured by EDSS, including visual function, bowel and bladder dysfunction, balance, and sensory functions1
Percentage of AQP4-IgG+ patients with worsening disability from baseline at last visit1b

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

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.

bWorsening disability was assessed by the EDSS at last visit during the RCP, defined as 1) worsening of 2 or more points in EDSS score for subjects with baseline score of 0; (2) worsening of 1 or more points in EDSS score for subjects with baseline score of 1 to 5; (3) or worsening of 0.5 points or more in EDSS score for subjects with baseline score of 5.5 or more.

B-Cell Depletion

UPLIZNA provided rapid and sustained B-cell depletion2-4

With UPLIZNA, B-cell depletion was demonstrated at 8 days and at all time points3

B-cell counts over 3 years3,4c
Graph illustrating UPLIZNA efficacy in rapid and sustained B-cell depletion over 3 years, showing demonstrated reductions at 8 days and at all timepoints Graph illustrating UPLIZNA efficacy in rapid and sustained B-cell depletion over 3 years, showing demonstrated reductions at 8 days and at all timepoints Graph illustrating UPLIZNA efficacy in rapid and sustained B-cell depletion over 3 years, showing demonstrated reductions at 8 days and at all timepoints
  • UPLIZNA delivered 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
  • Patients receiving placebo who switched to UPLIZNA saw a similar reduction in B-cell counts1

Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. Reprinted from The Lancet, Vol 394, Cree BA, Bennett JL, Kim HJ, et al., Inebilizumab for the treatment of neuromyelitis optics spectrum disorder (N-MOmentum): a double-blind, randomized placebo-controlled phase 2/3 trial, page 7. Copyright 2019, with permission from Elsevier.

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

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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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safety profile

AQP4-IgG+, aquaporin-4-immunoglobulin G positive; EDSS, Expanded Disability Status Scale; Gd, gadolinium; ITT, intention-to-treat; NMOSD, neuromyelitis optica spectrum disorder; OLP, open-label period; 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…

WARNINGS AND PRECAUTIONS Infusion Reactions: UPLIZNA can cause infusion reactions…

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.

Please see Full Prescribing Information for more information.

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…

WARNINGS AND PRECAUTIONS Infusion Reactions: UPLIZNA can cause infusion reactions…

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.

Please see Full Prescribing Information for more information.

  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. EBioMedicine. 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