Study Design

N-MOmentum is the largest NMOSD trial
to date (n=230)1-5a

96% of patients who received UPLIZNA in the RCP opted into the OLP extending
4+ years1-6b
Graphic illustrating the UPLIZNA N-MOmentum study design Graphic illustrating the UPLIZNA N-MOmentum study design Graphic illustrating the UPLIZNA N-MOmentum study design

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, 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.1,7

  • Well-defined primary endpoint: time to onset of attack beginning at day 1 through day 1971
  • Secondary endpoints evaluated many aspects of living with NMOSD, including:
    • 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

Inclusion Criteria

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

Included 230 patients from 25
countries across 99 sites1

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

Select baseline patient characteristics5
  • 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
  • Polymorphisms: 48% had the F/F genotype for the Fcgr3a polymorphism8

N-MOmentum featured the most robust attack adjudication process of any NMOSD trial1,5,9

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
  • N-MOmentum had the highest level of agreement between trial investigators and attack adjudication committee in any NMOSD trial to date9
Arrow

Out of 22 investigator-determined attacks in AQP4-IgG+ patients on UPLIZNA in the RCP, only 4 (18.2%) were rejected by the adjudication committee9

Attack adjudication featured 18 comprehensive criteria across 4 distinct domains1
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		 as measured in either eye alone (monocular) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the corresponding optic nerve
11 Reduction of ≥ 1 step in CF to NLP from last visit as measured in a previously affected eye and a new Gd-enhancing or new/enlarging T2 MRI lesion in the corresponding optic nerve
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		 as measured in either eye alone (monocular) and a new Gd-enhancing or new/enlarging T2 MRI lesion in the corresponding optic nerve
11 Reduction of ≥ 1 step in CF to NLP from last visit as measured in a previously affected eye and a new Gd-enhancing or new/enlarging T2 MRI lesion in the corresponding optic nerve
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 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
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 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
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 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 NMOSD10

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See how UPLIZNA
reduces NMOSD attacks7

aN-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, 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.

bIn the AQP4-IgG+ patient population.

cDue 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

AQP4-IgG+, aquaporin-4 immunoglobulin G positive; AQP4-IgG-, aquaporin-4 immunoglobulin G negative; AZA, azathioprine; CF, counting fingers; EDSS, Expanded Disability Status Scale; 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.

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
  • 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(10206):1352-1363. doi:10.1016/S0140-6736(19)31817-3
  2. Rensel M, Zabeti A, Mealy MA, 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. ENSPRYNG® (satralizumab-mgwe) [prescribing information] Genentech, Inc. 
  4.  SOLIRIS® (eculizumab) [prescribing information] Alexion Pharmaceuticals, Inc.
  5. Data on File. Horizon, June 2020.
  6. 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;27(13):2052-2061. doi:10.1177/1352458521988926
  7. UPLIZNA (inebilizumab-cdon) [prescribing information] Horizon.
  8.  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: The 16th World Congress on Controversies in Neurology (virtual); March 24-27, 2022.
  9. 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
  10. 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