STUDY DESIGN

UPLIZNA WAS STUDIED AS A MONOTHERAPY IN THE LARGEST PROSPECTIVE, PLACEBO-CONTROLLED CLINICAL TRIAL IN NMOSD1

N-MOmentum was a phase 2/3, multicenter, double-blind, randomized placebo-controlled trial with an open-label period1-3

UPLIZNA study design chartscreening

Randomized controlled period studied 213 AQP4-IgG+ patients and 17 AQP4-IgG–patients for 6 months1

  • Inclusion criteria: Adults diagnosed with NMOSD, EDSS score ≤8.0, and a history of ≥1 attack requiring rescue therapy during the year before screening or ≥2 attacks requiring rescue therapy in the 2 years before screening1
  • Well-defined primary endpoint: Time to onset of an NMOSD attack by day 1971
  • Robust attack adjudication: All attacks were verified by an independent relapse-adjudication committee using 18 predefined attack criteria1-3
  • Dosing: Patients were randomized to receive UPLIZNA 300-mg IV or placebo1
  • Patients who had an attack or completed the randomized controlled period could enter the open-label period4

96%

of UPLIZNA patients opted to continue treatment in the open-label period2

N-MOMENTUM WAS DESIGNED TO REFLECT THE REAL-WORLD NMOSD PATIENT POPULATION

N-MOMENTUM recruited 213 AQP4-IgG+ patients from 25 countries across
99 sites1,5

Baseline characteristics in the randomized controlled period1,5

Mean age 43 years
Gender 94% Female
Race 53% White; 23% Asian; 9% African American; 7% other
Ethnicity 16% Hispanic or Latino
≥ 2 attacks (2 years prior) 83%
Median disease duration 1.1 years (patients randomized to receive UPLIZNA)
Median baseline EDSS 3.5 (range 0 to 8)

Patients were recruited from diverse backgrounds to provide clinically relevant results1

Globe

AQP4, aquaporin-4; EDSS, expanded disability status scale; IgG-, immunoglobulin G negative; IgG+, immunoglobulin G positive; NMOSD, neuromyelitis optica spectrum disorder.

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. 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.
  2. Data on File. Horizon, June 2020.
  3. Cree BAC, Bennett JL, Kim HJ, et al. Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD. Mult Scler. 2021;1-10. doi:10.1177/1352458521988926.
  4. Cree BAC, Bennett JL, Weinshenker BG, et al. Long-term efficacy outcomes with inebilizumab treatment in neuromyelitis optica spectrum disorder: the N-MOmentum trial. Poster P2329 presented at: The American Association of Neurology (virtual); April 17-22, 2021.
  5. UPLIZNA (inebilizumab-cdon) [prescribing information] Horizon.