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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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Switch Patients

Switching Patients to a
CD19 Targeted Therapy

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Carla is a real patient who switched to UPLIZNA in 2017. 
Individual results may vary. Hear her story.

In a post hoc analysis, UPLIZNA decreased the rate of attacks in patients with prior rituximab use1*

Group 18482

UPLIZNA and rituximab have not been studied in a head-to-head clinical trial.
The analyses above were not powered to detect differences within subgroups and results should be considered descriptive and exploratory.

*Data from a post hoc analysis of N-MOmentum conducted by EP Flanagan et al.1

†Median time between last rituximab dose and first dose of UPLIZNA was 1.5 years (range: 0.8-4.4).1

Patients who experienced breakthrough attacks with rituximab prior to the RCP were attack free with UPLIZNA (n=7)1

UPLIZNA and rituximab have not been studied in a head-to-head clinical trial.
The analyses above were not powered to detect differences within subgroups and results should be considered descriptive and exploratory.

*Data from a post hoc analysis of N-MOmentum conducted by EP Flanagan et al.1

CD20+ B-cell counts decreased in all participants with prior rituximab use1*

cd20-chart
3.0_Graph 4_Mob

Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

*Data from a post hoc analysis of N-MOmentum conducted by EP Flanagan et al.1

†For CD19+ B-cell counts, assays for CD20+ B cells are used because the presence of UPLIZNA interferes with CD19+ B-cell assay.3

Targeting CD19 vs CD20

CD19-expressing cells are central drivers of NMOSD activity and disease immunopathogenesis. UPLIZNA is the only FDA-approved therapy for NMOSD that eliminates a primary cellular source of AQP4-IgG production by reducing CD19+ B cells, including plasmablasts and some plasma cells.4-7 The precise mechanism by which UPLIZNA exerts its therapeutic effects in NMOSD is unknown.4-7

UPLIZNA targets CD19, which is expressed across the B-cell lineage5,7-9

CD19 vs CD20

c19-c20
3.0_CD19_Graph_SVG
3.0_CD20_Graph_SVG

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Understanding the infusion experience

AAR, annualized attack rate; AQP4-IgG, aquaporin-4-immunoglobulin G; OLP, open-label period; 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. Flanagan EP, Levy M, Katz E, et al. 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
    2. Cree BAC, Bennett JL, Kim HJ, et al; N-MOmentum study investigators. 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
    3. Data on File. Horizon; June 2021.
    4. Bennett JL, O’Connor KC, Bar-Or A, et al. B lymphocytes in neuromyelitis optica. Neurol Neuroimmunol Neuroinflamm. 2015;2(3):e104. doi:10.1212/NXI.0000000000000104
    5. Forsthuber TG, Cimbora DM, Ratchford JN, Katz E, Stüve O. B cell-based therapies in CNS autoimmunity: differentiating CD19 and CD20 as therapeutic targets. Ther Adv Neurol Disord. 2018;11:1-13. doi:10.1177/1756286418761697
    6. UPLIZNA (inebilizumab-cdon) [prescribing information]. Horizon.
    7. Baker D, Marta M, Pryce G, et al. Memory B cells are major targets for effective immunotherapy in relapsing multiple sclerosis. EBioMedicine. 2017;16:41-50. doi:10.1016/j.ebiom.2017.01.042
    8. Ho JWK, Koundinya R, Caetano TS, et al. Inferring differential leukocyte activity from antibody microarrays using a latent variable model. Genome Informatics. International Conference on Genome Informatics. 2008;21:126-137. doi:10.1142/9781848163324_0011
    9. Hultin LE, Hausner MA, Hultin PM, et al. CD20 (pan-B cell) antigen is expressed at a low level on a subpopulation of human T lymphocytes. Cytometry. 1993;14(2):196-204.