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Additional consensus statements from the international panel of NMOSD experts included:

  • Treatment with monotherapy is preferable to reduce IST-related side effects10
  • Patient preference should be a consideration when initiating or switching treatment10
  • Current clinical disease activity, serious treatment-related adverse events, and patient preference for another therapy should warrant switching treatment10
  • Vaccinations should be kept up to date, with specific guidance concerning meningococcal vaccination when prescribing eculizumab10

The NMOSD Delphi Panel was convened to develop validated recommendations on the treatment of AQP4-IgG+ patients with NMOSD. This international panel of clinical experts drafted consensus statements regarding therapy initiation, monotherapy vs combination therapy, switching therapies, patient populations, safety, use of biomarkers and patient-reported outcomes, and gaps in research. Of 18 panelists, 14 agreed on the same initiation criteria for eculizumab, and 17 for satralizumab. Each therapy met the panel’s predefined consensus threshold (67% or greater).


AQP4-IgG+, aquaporin-4-immunoglobulin G positive; IST, immunosuppressive therapy; NMOSD, neuromyelitis optica spectrum disorder.

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on what's ahead with Uplizna.

All NMOSD treatments can lower the risk of attacks. But what about other disease complications, treatment considerations, and time lost to frequent dosing?

Only UPLIZNA delivers the combination of protection beyond attacks, an established safety profile, and twice-yearly dosing.1-3*

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In the largest NMOSD trial of a monotherapy to date, UPLIZNA provided4-7:

Significant reduction
in risk of attack1,2

Attack Reduction

UPLIZNA delivered significant protection from attacks, with a 77% relative risk reduction vs placebo

• In a 6-month study, 11% of patients on UPLIZNA and 42% on placebo experienced an attack (HR=0.227 [95% CI: 0.121-0.423], P<0.0001)2†

Protection
beyond attacks1,3

Efficacy Beyond Attacks

In the RCP, patients experienced a 78% reduction in annualized rates of hospitalizations(0.11 versus 0.50 for placebo)2†

An established
safety profile2,3

Safety

>2275 patient-years of experience in NMOSD8

Twice-yearly
dosing2a

Dosing Information

More infusion-free time2

*Twice-yearly dosing occurs after 2 initial doses.
†Data in AQP4-IgG+ patients (n=213).

More reasons to choose this FDA-approved treatment chosen by more than 1475 patients5

CLINICAL EXPERIENCE

CLINICAL EXPERIENCE

UPLIZNA has established safety and efficacy profiles, with more than 6000 doses administered since 20208

90 PERSISTENCE

~95% PERSISTENCE

Approximately 95% of patients who started on UPLIZNA stayed on UPLIZNA (data from US patients enrolled in Amgen by Your Side).8*

CHOSEN BY SPECIALISTS

CHOSEN BY SPECIALISTS UPLIZNA is well-established in NMOSD specialty care,

prescribed by more than 600 neurologists/neuro-ophthalmologists8

*Data from 10/01/2023-09/30/2024 for 1,307 patients enrolled in Amgen By Your Side who received a dose of UPLIZNA within 6 months of the start date and received or are scheduled to receive their next dose within 6 months of the end date of the analysis.

homepage5

Inebilizumab was the only treatment to receive 100% consensus recommendation for initiation at diagnosis, after first attack, or after relapse due to failure of existing treatments in adults with AQP4-IgG+ NMOSD.9

See additional consensus statements

§The NMOSD Delphi Panel was convened to develop validated recommendations on the treatment of AQP4-IgG+ patients with NMOSD. This international panel of clinical experts drafted consensus statements regarding therapy initiation, monotherapy vs combination therapy, switching therapies, patient populations, safety, use of biomarkers and patient-reported outcomes, and gaps in research. Of those 18 panelists, 14 agreed on the same initiation criteria for eculizumab, and 17 for satralizumab. Each therapy met the panel’s predefined consensus threshold (67% or greater).

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AQP4-IgG+, aquaporin-4-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.

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. 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
    2. UPLIZNA (inebilizumab-cdon) [prescribing information]. Horizon.
    3. Data on File. Horizon; June 2020.
    4. 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
    5. ENSPRYNG® (satralizumab-mwge) [prescribing information]. Genentech, Inc.
    6. SOLIRIS® (eculizumab) [prescribing information]. Alexion Pharmaceuticals, Inc.
    7. ULTOMIRIS® (ravulizumab-cwvz) [prescribing information]. Alexion Pharmaceuticals, Inc.
    8. Data on File. Amgen; October 2024.
    9. Paul F, Marignier R, Palace J, et al. International Delphi Consensus on the management of AQP4-IgG+ NMOSD: recommendations for eculizumab, inebilizumab, and satralizumab. Neurol Neuroimmunol Neuroinflamm. 2023;10(4):1-16. doi:10.1212/NXl.0000000000200124