INDICATIONS 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.

uplizna-logo

Choose Indication

Please select
Patient Enrollment Form
Request Support

You are now leaving UPLIZNAhcp.com

Horizon is not responsible for the content of external websites linked within UPLIZNAhcp.com.

Do you want to continue?

Yes No

CD19+ cells are a primary cellular source of AQP4-IgG production2

cd-expressions-across-bcell-lineage-chart-1

CD19 is expressed across the B-cell lineage. Targeting CD19 provides effective B-cell depletion while sparing other types of immune cells.3-5*

Compare CD19 and CD20 expressions across the B-cell lineage

*UPLIZNA had no effect on anti-tetanus IgG levels in the RCP.6

UPLIZNA is designed to help address the multifaceted immunopathogenesis of NMOSD1,2

UPLIZNA Mechanism of Action

  • Transcript

    UPLIZNA is an immunoglobulin G1, or IgG1, monoclonal antibody that is humanized, afucosylated, and binds specifically to CD19 for efficient B-cell depletion.

    While the precise mechanism by which inebilizumab-cdon exerts its therapeutic effects is unknown, preclinical and clinical evidence of B-cell depletion suggest potential activity in aquaporin-4–positive neuromyelitis optica spectrum disorder, or NMOSD.

    CD19 is present on pre-B cells, mature B cells, plasmablasts, and some plasma cells that contribute to NMOSD’s multimechanistic pathology through autoantibody production, cytokine/chemokine secretion, antigen presentation, and T-cell interactions.

    UPLIZNA bound to CD19 surface antigen enables antibody-dependent cellular cytolysis, ADCC, that lowered peripheral B-cell counts after 8 days, and allowed 100% of patients to experience B-cell reductions below the lower limit of normal by 4 weeks.

    The engineering of UPLIZNA contributes to its differentiated mechanistic and clinical profile, efficient depletion of CD19-positive B cells through enhanced ADCC, low rates of drug-drug interactions, low rates of anti-drug antibody generation, low rates of infusion reactions, 6-month maintenance dosing, and depletion of the spectrum of CD19-positive B cells that activate autoimmune and inflammatory disease mechanisms.

    UPLIZNA is FDA approved for use in adults with AQP4-antibody–positive NMOSD.

    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.

Key factors in NMOSD pathogenesis include:

Autoantibody productionAutoantibody production²
Cytokine secretionCytokine secretion²
Antigen presentationAntigen presentation²
T-cell interactionsT-cell interactions²

The precise mechanism by which UPLIZNA exerts its therapeutic effects in NMOSD is unknown.1

UPLIZNA is designed for efficacy and tolerability

mechanism-of-action-cta-1

Glycoengineered Design

  • Approximately 40% of the population is homozygous for a genetic risk factor that can diminish the efficacy of many monoclonal antibodies7-9
  • UPLIZNA was specifically glycoengineered to overcome this genetic barrier7
mechanism-of-action-cta-1

Glycoengineered Design

  • UPLIZNA is an affinity-optimized monoclonal antibody1,10,11
  • Glycoengineering involves removing the fucose sugar molecule, which allows for1,10,11:
    • Efficient binding of effector natural killer cells
    • Effective B-cell depletion without the need for dose adjustments
mechanism-of-action-banner-cta-2mechanism-of-action-banner-cta-2

Humanized Structure

UPLIZNA has a humanized structure. Compared with chimeric structures, humanized structures are associated with1,6,12,13:

  • Reduced immunogenicity
  • Improved tolerability
  • Decreased potential infusion-related reactions

selective-engineeringselective-engineering

Selective Targeting

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.1-4

The precise mechanism by which UPLIZNA exerts its therapeutic effects in NMOSD is unknown.1

  • mechanism-of-action-cta-1

    Glycoengineered Design

    • Approximately 40% of the population is homozygous for a genetic risk factor that can diminish the efficacy of many monoclonal antibodies7-9
    • UPLIZNA was specifically glycoengineered to overcome this genetic barrier7
    mechanism-of-action-cta-1

    Glycoengineered Design

    • UPLIZNA is an affinity-optimized monoclonal antibody1,10,11
    • Glycoengineering involves removing the fucose sugar molecule, which allows for1,10,11:
      • Efficient binding of effector natural killer cells
      • Effective B-cell depletion without the need for dose adjustments
1
2
3

Results should be considered exploratory.

AQP4-IgG, aquaporin-4 immunoglobulin G; NMOSD, neuromyelitis optica spectrum disorder.

Glycoengineered Design

  • Transcript

    Studies have shown that about 40% of the population has a genetic variation (or polymorphism) that results in a mutation of the Fc gamma receptor 3A (FCGR3A) found on their natural killer (NK) cells.

    This genetic mutation reduces the receptor’s ability to bind to monoclonal antibodies, which act as a tether to bring pathogenic B cells to NK cells for destruction via antibody-dependent cellular cytotoxicity (ADCC).

    As a result, this genetic variant impacts the ability of this population to achieve efficacy from certain monoclonal antibodies.

    In neuromyelitis optica spectrum disorder (NMOSD), patients with this polymorphism who are receiving rituximab may experience insufficient B-cell depletion, require earlier retreatment, and may be at an increased risk of experiencing an attack.

    UPLIZNA (inebilizumab) was specifically designed to overcome this genetic barrier. During its development, the Fc region of UPLIZNA was modified in a way to specifically remove a fucose sugar molecule in a process called glycoengineering.

    This glycoengineered design of UPLIZNA results in an approximately 10-fold increased affinity, or ability to bind to the FCGR3A receptor on NK cells, regardless of genotype, and thus may enhance ADCC.

    For patients with NMOSD, UPLIZNA has demonstrated effective B-cell depletion without the need for dose adjustments, as well as consistent reductions in attack rate, regardless of genotype.

    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.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis. 

WARNINGS AND PRECAUTIONS

  • Infusion Reactions: Can cause infusion reactions, including anaphylaxis. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. During the randomized clinical trial period (RCP), infusion reactions were observed with the first course of UPLIZNA in 9.3% of NMOSD patients. Infusion reactions of UPLIZNA were observed in 7.4% of IgG4-RD patients during the RCP. 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 antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. 
  • Infections: An increased risk of infections has been observed with other B-cell depleting therapies. The most common infections reported by UPLIZNA-treated patients in the NMOSD RCP and open-label clinical trial periods were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP and open-label period, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved. 

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: UPLIZNA has not been studied in combination with other immunosuppressants. If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: Risk of HBV reactivation has been observed with other B-cell depleting antibodies. There have been no cases of HBV reactivation in patients treated with UPLIZNA, but patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.

    Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of 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. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. 

    Tuberculosis
    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment.

    Vaccinations
    Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. 
    Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
    In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in these exposed infants may increase the risks from live or live-attenuated vaccines.  Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
  • Reductions 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 levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. 
  • Fetal Risk: Based on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose. 

ADVERSE REACTIONS

  • The most common adverse reactions in NMOSD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.
  • The most common adverse reactions in IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infections and lymphopenia. 

INDICATIONS

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.

UPLIZNA® is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

Please see UPLIZNA Full Prescribing Information.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis. 

WARNINGS AND PRECAUTIONS 

  • Infusion Reactions: Can cause infusion reactions, including anaphylaxis. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. During the randomized clinical trial period (RCP), infusion reactions were observed with the first course of UPLIZNA in 9.3% of NMOSD patients. Infusion reactions of UPLIZNA were observed in 7.4% of IgG4-RD patients during the RCP. 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 antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

  • Infections: An increased risk of infections has been observed with other B-cell depleting therapies. The most common infections reported by UPLIZNA-treated patients in the NMOSD RCP and open-label clinical trial periods were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP and open-label period, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: UPLIZNA has not been studied in combination with other immunosuppressants. If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: Risk of HBV reactivation has been observed with other B-cell depleting antibodies. There have been no cases of HBV reactivation in patients treated with UPLIZNA, but patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment. 

    Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of 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. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. 

    Tuberculosis
    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment. 

    Vaccinations
    Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. 
    Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
    In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in these exposed infants may increase the risks from live or live-attenuated vaccines.  Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
  • Reductions 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 levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
  • Fetal Risk: BBased on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose..

ADVERSE REACTIONS

  • The most common adverse reactions in NMOSD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia. 
  • The most common adverse reactions in IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infections and lymphopenia.

INDICATIONS

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.

UPLIZNA® is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

Please see UPLIZNA Full Prescribing Information.

  • REFERENCES:
    1. UPLIZNA (inebilizumab-cdon) [prescribing information]. Horizon.
    2. 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
    3. 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
    4. 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
    5. 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
    6. 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
    7. Kim HJ, Aktas O, Patterson KR, et al. Inebilizumab reduces neuromyelitis optica spectrum disorder risk independent of FCGR3A polymorphism. Ann Clin Translat Neurol. 2023;10(12):2413-2420. doi:10.1002/acn3.51911
    8. Aktas O, Bennett JL, Winshenker 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: 16th World Congress on Controversies in Neurology (virtual); March 24-27, 2022.
    9. Kim S-H, Jeong IH, Hyun J-W, et al. Treatment outcomes with rituximab in 100 patients with neuromyelitis optica: influence of FCGR3A polymorphisms on the therapeutic response to rituximab. JAMA Neurol. 2015;72(8):989-995. doi:10.1001/jamaneurol.2015.1276
    10. Herbst R, Wang Y, Gallagher S, et al. B-cell depletion in vitro and in vivo with an afucosylated anti-CD19 antibody. J Pharmacol Exp Ther. 2010;335(1):213-222. doi:10.1124/jpet.110.168062
    11. Ward E, Mittereder N, Kuta E, et al. A glycoengineered anti-CD19 antibody with potent antibody-dependent cellular cytotoxicity activity in vitro and lymphoma growth inhibition in vivo. Br J Haematol. 2011;155(4):426-437. doi:10.1111/j.1365-2141.2011.08857.x
    12. Hwang WYK, Foote J. Immunogenicity of engineered antibodies. Methods. 2005;36(1):3-10. doi:10.1016/j.ymeth.2005.01.001
    13. Harding FA, Stickler MM, Razo J, DuBridge RB. The immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regions. MAbs. 2010;2(3):256-265. doi:10.4161/j.mabs.2.3.11641