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Switching Patients to a CD19-Targeted Therapy

UPLIZNA patient, JasmineUPLIZNA patient, JasmineUPLIZNA patient, Jasmine

Annualized Attack Rate
Patient-Specific Attack Reduction
B-Cell Depletion

Annualized Attack Rate

In a post hoc analysis, UPLIZNA decreased the rate of attacks
in patients with prior rituximab use1a
Chart showing a 10-fold decrease in attacks/person-year after initial dose of UPLIZNA among patients with prior rituximab use (n=17) Chart showing a 10-fold decrease in attacks/person-year after initial dose of UPLIZNA among patients with prior rituximab use (n=17) Chart showing a 10-fold decrease in attacks/person-year after initial dose of UPLIZNA among patients with prior rituximab use (n=17)

The data above are from a post hoc subgroup analysis of N-MOmentum in patients previously treated with rituximab (n=17). Analysis was not powered to detect differences within subgroups and results should be considered descriptive and exploratory. UPLIZNA has not been studied head-to-head with rituximab.

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

Patient-Specific Attack Reduction

Patients who experienced breakthrough attacks with rituximab prior to the RCP were attack free with UPLIZNA (n=7)1
Summary of attack data in 17 N-MOmentum participants with prior rituximab use1a
Graph showing a summary of attack data in 17 N-MOmentum participants with prior rituximab use at Year -9 through Year 4, with both placebo (n=4) and UPLIZNA (n=13) groups Graph showing a summary of attack data in 17 N-MOmentum participants with prior rituximab use at Year -9 through Year 4, with both placebo (n=4) and UPLIZNA (n=13) groups Graph showing a summary of attack data in 17 N-MOmentum participants with prior rituximab use at Year -9 through Year 4, with both placebo (n=4) and UPLIZNA (n=13) groups
Results during treatment with UPLIZNA1a
Treatment Results Graph Treatment Results Graph Treatment Results Graph

B-Cell Depletion

Patients who experienced an attack while on rituximab were attack free on UPLIZNA1a
Graph showing a summary of attack data in 17 N-MOmentum participants with prior rituximab use at Year -9 through Year 4, highlighting that participants who experienced an attack while on rituximab were attack free on UPLIZNA Graph showing a summary of attack data in 17 N-MOmentum participants with prior rituximab use at Year -9 through Year 4, highlighting that participants who experienced an attack while on rituximab were attack free on UPLIZNA Graph showing a summary of attack data in 17 N-MOmentum participants with prior rituximab use at Year -9 through Year 4, highlighting that participants who experienced an attack while on rituximab were attack free on UPLIZNA

The data above are from a post hoc subgroup analysis of N-MOmentum in patients previously treated with rituximab (n=17). Analysis was not powered to detect differences within subgroups and results should be considered descriptive and exploratory. UPLIZNA has not been studied head-to-head with rituximab.

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

CD20+ B-cell counts decreased in all participants with prior rituximab use1
Graph showing absolute CD20+ B-cell counts of individual participants with prior rituximab use during the RCP and OLP Graph showing absolute CD20+ B-cell counts of individual participants with prior rituximab use during the RCP and OLP Graph showing absolute CD20+ B-cell counts of individual participants with prior rituximab use during the RCP and OLP

aData from a post hoc analysis of N-MOmentum conducted by EP Flanagan et al. Median time between last rituximab dose and first dose of UPLIZNA was 1.5 years (range: 0.8 to 4.4).

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

Targeting CD19 vs CD20

CD19-expressing cells are a central driver of NMOSD activity and disease immunopathogenesis. Targeting CD19+ cells eliminates a primary cellular source of AQP4-IgG production, including plasmablasts and some plasma cells.3-6 The precise mechanism by which UPLIZNA exerts its therapeutic effects in NMOSD is unknown.

UPLIZNA targets CD19, which is expressed across the B-cell lineage4,6-8

Chart showing CD19 vs CD20 in B-cell lineage Chart showing CD19 vs CD20 in B-cell lineage Chart showing CD19 vs CD20 in B-cell lineage

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Understanding the infusion experience

AAR, annualized attack rate; OLP, open-label period; 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…

WARNINGS AND PRECAUTIONS Infusion Reactions: UPLIZNA can cause infusion reactions…

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…

WARNINGS AND PRECAUTIONS Infusion Reactions: UPLIZNA can cause infusion reactions…

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.

  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. 2021. 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. 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
  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. UPLIZNA (inebilizumab) [prescribing information] Horizon.
  6. 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
  7. 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
  8. 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.