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Days 1 through 21: prednisone 20 mg (or equivalent) taper1

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Days 1 through 21: prednisone 20 mg (or equivalent) taper1

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Studied exclusively as monotherapy5

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The majority of patients chose to enter the open-label period:
96% of patients who received UPLIZNA5
90% of patients randomized to placebo5

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The majority of patients chose to enter the open-label period:

96% of patients who received UPLIZNA5
90% of patients randomized to placebo5

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Studied exclusively as monotherapy5

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  • Full Study Description

    N-MOmentum was a phase 2/3, multicenter, double-blind, randomized (3:1) placebo-controlled trial with an OLP. The RCP studied 213 AQP4-IgG+ patients and 17 AQP4-IgG– patients for 6 months (197 days). Inclusion criteria specified adults diagnosed with NMOSD, an 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 screening.1,6

    • Well-defined primary endpoint: time to onset of attack beginning at Day 1 through Day 1971
    • Key secondary endpoints evaluated many aspects of living with NMOSD, including1:
    • Worsening of EDSS as defined by an increase of ≥2 from baseline of 0 to 1, increase of ≥1 from baseline of 1 to 5, or increase in ≥0.5 from baseline of ≥5.5
    • Cumulative MRI lesions, including new Gd-enhancing lesions and new or enlarging T2 lesions
    • Hospitalizations, defined as inpatient stays of ≥1 night
    • Changes in visual acuity as measured by low-contrast binocular score

    An Independent Data Monitoring Committee (IDMC) agreed that a placebo comparator and monotherapy design would best enable the evaluation of the efficacy and safety of UPLIZNA. Certain features reduced the risk to placebo-treated patients, including limiting the length of the RCP to 6.5 months and allowing placebo-treated subjects to immediately enter the OLP following an attack.5

Enrollment to the study was stopped at 231 patients when the IDMC determined that the efficacy of UPLIZNA was demonstrated, and no further patients should be given placebo treatment5

*In the AQP4-IgG+ patient population.5

†Due to a half-life of ≤24 hours, AZA and MMF were allowed up until Day 1. Rituximab was stopped 6 months prior to randomization, unless the patient had B-cell counts above the LLN.5

Inclusion Criteria

The inclusion criteria for N-MOmentum were designed to ensure the trial reflected the real-world patient population with NMOSD1

Inclusion_criteria_icon

Included 230 patients from 25
countries across 99 sites1

NMOSD_Walker_icon

Enrolled patients with an EDSS
score ≤8.0, the highest degree of disability permitted in NMOSD clinical trials6

Baseline characteristics in the AQP4-IgG+ population receiving UPLIZNA (n=161)5
  • Mean age: 43 years
  • Sex: 94% female
  • Race: 53% White, 23% Asian, 9% Black or African American, 7% American Indian or Alaskan Native, 8% Other
  • Ethnicity: 16% Hispanic or Latino
  • Mean EDSS (range=0 to 8.0): 3.81
  • Mean Gd-enhancing lesions: 1.2
  • Genetic mutations: 48% out of 142 patients who consented to genotyping had the F/F genotype for the receptor encoded by FCGR3A7

N-MOmentum featured the most robust attack adjudication process of any NMOSD trial1,5,8

The NMOSD-specific 18-point attack criteria ensured investigators captured any sign or symptom of a new attack, from the most subtle to the most severe1,5
  • Attack criteria accounted for all potential domains of disease activity1

Out of 22 investigator-determined attacks in AQP4-IgG+ patients on UPLIZNA in the RCP, only 4 (18.2%) were rejected by the adjudication committee8

Attack adjudication featured 18 comprehensive criteria across 4 distinct domains1
  • Optic Icon
    1 Landolt C Broken
    Ring Chart    		 >15-character drop in high-contrast LCBRC from last visit as measured in a previously affected eye and no other ophthalmological explanation
    2 Reduction of ≥2 steps in CF to NLP from last visit
    3 Reduction of ≥7 characters in
    low-contrast LCBRC from last visit    		 as measured in either eye alone (monocular) and a new RAPD in the affected eye
    4 Reduction of ≥7 characters in
    high-contrast LCBRC from last visit
    5 Reduction of ≥5 characters in
    low-contrast LCBRC from last visit    		 as measured in either eye alone (monocular) and loss of a previously documented RAPD in the fellow eye
    6 Reduction of ≥5 characters in
    high-contrast LCBRC from last visit
    7 Reduction of ≥1 step in CF to NLP from last visit as measured in a previously affected eye and a new RAPD in the affected eye
    8 Reduction of ≥1 step in CF to NLP from last visit as measured in a previously affected eye and loss of a previously documented RAPD in the fellow eye
    9 MRI Reduction of ≥7 characters in low-contrast LCBRC from last visit as measured in either eye alone (monocular) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the corresponding optic nerve
    10 Reduction of ≥5 characters in high-contrast LCBRC from last visit
    11 Reduction of ≥1 step in CF to NLP from last visit
    Landolt C Broken Ring Chart
    1 >15-character drop in high-contrast
    LCBRC from last visit    		 as measured in a previously affected eye and no other ophthalmological explanation
    2 Reduction of ≥2 steps in CF to NLP from last visit
    3 Reduction of ≥7 characters in
    low-contrast LCBRC from last visit    		 as measured in either eye alone (monocular) and a new RAPD in the affected eye
    4 Reduction of ≥7 characters in
    high-contrast LCBRC from last visit
    5 Reduction of ≥5 characters in
    low-contrast LCBRC from last visit    		 as measured in either eye alone (monocular) and loss of a previously documented RAPD in the fellow eye
    6 Reduction of ≥5 characters in
    high-contrast LCBRC from last visit
    7 Reduction of ≥1 step in CF to NLP from last visit as measured in a previously affected eye and a new RAPD in the affected eye
    8 Reduction of ≥1 step in CF to NLP from last visit as measured in a previously affected eye and loss of a previously documented RAPD in the fellow eye
    MRI
    9 Reduction of ≥7 characters in low-contrast LCBRC from last visit as measured in either eye alone (monocular) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the corresponding optic nerve
    10 Reduction of ≥5 characters in high-contrast LCBRC from last visit
    11 Reduction of ≥1 step in CF to NLP from last visit
  • Optic Icon
    12 FSS Worsening of ≥2 points as compared with last visit as measured in at least 1 of the relevant FSS (pyramidal, bladder/bowel, sensory)
    13 EDSS Worsening of ≥1 point as compared with last visit as measured by EDSS if previous score was ≥5.5
    14 MRI Worsening of ≥1 point as compared with last visit when the last visit score was ≥1 as measured in at least 2 of the relevant FSS (pyramidal, bladder/bowel, sensory) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the spinal cord
    15 Worsening of ≥0.5 points score as compared with last visit if the previous score was ≥5.5 as measured by EDSS and a new Gd-enhancing or new/enlarging T2 MRI lesion in the spinal cord
    FSS
    12 Worsening of ≥2 points as compared with last visit as measured in at least 1 of the relevant FSS (pyramidal, bladder/bowel, sensory)
    EDSS
    13 Worsening of ≥1 point as compared with last visit as measured by EDSS if previous score was ≥5.5
    MRI
    14 Worsening of ≥1 point as compared with last visit as measured in at least 2 of the relevant FSS (pyramidal, bladder/bowel, sensory) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the spinal cord
    15 Worsening of ≥0.5 points score as compared with last visit if the previous score was ≥5.5 as measured by EDSS and a new Gd-enhancing or new/enlarging T2 MRI lesion in the spinal cord
  • Optic Icon
    16 MRI Isolated (not present at last visit) intractable nausea, vomiting, and/or hiccups lasting >48 hours accompanied by a new Gd-enhancing or new/enlarging T2 MRI lesion in the brain stem
    17 Worsening of ≥2 points as compared with last visit, with a score of ≥3 at the current visit as measured in at least one of the relevant FSS (cerebral, sensory, pyramidal) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the brain consistent with clinical presentation
    MRI
    16 Isolated (not present at last visit) intractable nausea, vomiting, and/or hiccups lasting >48 hours accompanied by a new Gd-enhancing or new/enlarging T2 MRI lesion in the brain stem
    17 Worsening of ≥2 points as compared with last visit, with a score of ≥3 at the current visit as measured by EDSS and a new Gd-enhancing or new/enlarging T2 MRI lesion in the spinal cord
  • Brain Icon
    18 MRI Worsening of ≥2 points as compared with last visit, with a score of ≥3 at the current visit as measured in at least one of the relevant FSS (cerebral, sensory, pyramidal) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the brain consistent with the clinical presentation
    MRI
    18 Worsening of ≥2 points as compared with last visit, with a score of ≥3 at the current visit as measured in at least one of the relevant FSS (cerebral, sensory, pyramidal) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the brain consistent with the clinical presentation

Optic neuritis, transverse myelitis, area postrema, acute brain stem syndrome, and symptomatic cerebral syndrome are part of the 6 core clinical characteristics of NMOSD9

See how UPLIZNA reduced NMOSD attacks6

AQP4-IgG, aquaporin-4 immunoglobulin G; AZA, azathioprine; CF, counting fingers; EDSS, Expanded Disability Status Scale; FCGR3A, Fc gamma receptor 3; FSS, functional systems score; Gd, gadolinium; ITT, intention-to-treat; LCBRC, Landolt C broken ring chart; LLN, lower limit of normal; MMF, mycophenolate mofetil; NLP, no light perception; NMOSD, neuromyelitis optica spectrum disorder; OLP, open-label period; RAPD, relative afferent pupillary defect; 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.

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
  • 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.

  • REFERENCES:
    1. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomized placebo-controlled phase 2/3 trial. Lancet. 2019;394(10206):1352-1363. doi:10.1016/S0140-6736(19)31817-3
    2. ENSPRYNG® (satralizumab-mwge) [prescribing information] Genentech, Inc.
    3. SOLIRIS® (eculizumab) [prescribing information] Alexion Pharmaceuticals, Inc.
    4. ULTOMIRIS® (ravulizumab-cwvz) [prescribing information]. Alexion Pharmaceuticals, Inc.
    5. Data on File. Horizon; June 2021.
    6. UPLIZNA (inebilizumab-cdon) [prescribing information] Horizon.
    7. Kim HJ, Aktas O, Patterson KR, et al. Inebilizumab reduces neuromyelitis optica spectrum disorder risk independent of FCGR3A polymorphism. Ann Clin Transl Neurol. 2023;10(12):2413-2420. doi:10.1002/acn3.51911
    8. Cree BAC, Greenberg B, Cameron C, Weinshenker BG. Letter to the Editor Regarding “Network meta-analysis of Food and Drug Administration-approved treatment options for adults with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder.” Neurol Ther. 2022;11(3):1439-1443. doi:10.1007/s40120-022-00376-2
    9. Wingerchuk DM, Banwell B, Bennett JL, et al; International Panel for NMO Diagnosis. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015;85(2):177-189. doi:0.1212/WNL.0000000000001729