NMOSD Attack Reduction

UPLIZNA provides robust protection against NMOSD attacks1

UPLIZNA significantly reduced attacks
in the RCP1

NMOSD patient, Mary

Time to adjudicated attack1a

Chart showing UPLIZNA efficacy through a 77% relative reduction vs placebo in risk of NMOSD attack at 197 days

Chart showing UPLIZNA efficacy through a 77% relative reduction vs placebo in risk of NMOSD attack at 197 days

aAQP4-IgG+ population (n=213).1

  • UPLIZNA delivered significant reduction in attacks through the first 28 weeks of treatment (77% reduction vs placebo; HR 0.227 [95% CI: 0.121-0.423]; P<.0001)1

A post hoc analysis of N-MOmentum was conducted to assess the efficacy of UPLIZNA in patients who had previously taken rituximab2 (n=17)
  • Patients who experienced breakthrough attacks while treated with rituximab were attack free with UPLIZNA (n=7)2
  • Patients previously on rituximab had an almost 10-fold decrease in AAR when treated with UPLIZNA (n=17; AAR prior to N-MOmentum was 0.78; AAR on UPLIZNA was 0.08)2

Freedom from attacks was sustained long-term3

Patients who remained on UPLIZNA after 2.5 years of treatment had a 97% reduction in attack rate3b
AAR over time3

Chart showing NMOSD annual attack rates of placebo group compared to UPLIZNA patients over 2.5 years, with the UPLIZNA patients observing a 97% reduction in attack rate past 2.5 yearsChart showing NMOSD annual attack rates of placebo group compared to UPLIZNA patients over 2.5 years, with the UPLIZNA patients observing a 97% reduction in attack rate past 2.5 years

bCompared to the AAR for placebo in the RCP. Data from a post hoc analysis of N-MOmentum conducted by JL Bennett et al. 168 patients were observed, representing 75% of the randomized population.3 AAR was calculated as the total number of relapses divided by the total number of patient-years.

Attack reduction icon
  • Most patients who remained attack free at year 1 remained attack free at year 44
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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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Explore the efficacy of UPLIZNA beyond attacks

AAR, annualized attack rate; AQP4, aquaporin-4; IgG+, immunoglobulin G positive; CI, confidence interval; HR, hazard ratio; 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. Flanagan EP, Levy M, Katz E, et al; N-MOmentum study investigators. Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum study. Mult Scler Relat Disord. 2022;57:103352. doi:10.1016/j.msard.2021.103352
  3. 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. doi: 10.1016/j.ebiom.2022.104321
  4. Cree BAC, Bennett JL, Weinshenker BG, et al. Safety and efficacy of inebilizumab in NMOSD over a mean treatment duration of 3.2 years: end of study data from the N-MOmentum trial. Poster AS-ECTRIMS-2021-00755 presented at: 37th Congress of ECTRIMS (virtual): October 13-15, 2021.