INDICATIONS
UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-...

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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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Robust Attack Reduction
  • Hospitalizations and Disability

Robust NMOSD attack reduction1

UPLIZNA significantly reduced the risk of attacks vs placebo in the RCP1

Time to adjudicated attack1,*

Chart showing how UPLIZNA® reduced the risk of NMOSD attacks vs placebo in the RCP
Chart showing how UPLIZNA® reduced the risk of NMOSD attacks vs placebo in the RCP

patients were attack free1

compared to ~6 out of 10 on placebo

UPLIZNA delivered significant reduction in attacks through the first 28 weeks of treatment, with a 77% relative risk reduction vs placebo; 11% of AQP4-IgG+ patients on UPLIZNA and 42% on placebo experienced an attack (HR=0.227 [95% CI: 0.121-0.423], P<0.0001 [primary endpoint])1,*

UPLIZNA continued to deliver long-lasting
protection from NMOSD attacks over 4+ years2

AAR over 4+ years2,†

Chart showing how UPLIZNA® delivered long-lasting protection for over 4+ years

Reprinted from The Lancet, Volume 23, Cree BAC, Kim HJ, Weinshenker BG, et al. Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial, page 596. Copyright 2024, with permission from Elsevier.

Consider open-label treatment phase study limitations when interpreting results. The OLP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. During the OLP, a total of 42 patients (19.4%) discontinued, of which 5 patients (2.3%) discontinued due to adverse events.2,‡,§

†Compared to placebo in the RCP. Data from a post hoc analysis of N-MOmentum conducted by BAC Cree et al.

‡Includes both AQP4-IgG+ and AQP4-IgG-negative patients.

§Compared to placebo in the RCP. Data from a post hoc analysis of N-MOMentum conducted by JL Bennett et al.

AAR, annualized attack rate; OLP, open-label period; RCP, randomized controlled period.

  • OLP enrollment

    The majority of patients from both treatment arms enrolled in the OLP2-4

    Chart comparing UPLIZNA® to placebo, showing the majority of patients from both treatment arms enrolled in the OLP Chart comparing UPLIZNA® to placebo, showing the majority of patients from both treatment arms enrolled in the OLP

    **One patient left the trial prior to beginning treatment.1,3,4

    ††lncludes both AQP4-lgG+ (n=213) and AQP4-lgG-negative (n=17) patients.1,4

In the RCP, AQP4-IgG+ patients receiving UPLIZNA had less NMOSD-related inpatient hospitalization and EDSS worsening5,6,‡‡

Graphic showing how AQP4-IgG+ patients receiving UPLIZNA® had 78% less NMOSD-related inpatient hospitalization and a 57% relative risk reduction in EDSS Graphic showing how AQP4-IgG+ patients receiving UPLIZNA® had 78% less NMOSD-related inpatient hospitalization and a 57% relative risk reduction in EDSS

Annual rate of hospitalizations in the RCP:

0.11 with UPLIZNA (n=161) vs 0.50 with placebo (n=52)1,5

Graphic showing how AQP4-IgG+ patients receiving UPLIZNA® had 78% less NMOSD-related inpatient hospitalization and a 57% relative risk reduction in EDSS Graphic showing how AQP4-IgG+ patients receiving UPLIZNA® had 78% less NMOSD-related inpatient hospitalization and a 57% relative risk reduction in EDSS

Percent of AQP4-IgG+ patients with worsening disability from baseline at last visit in the RCP:

15% with UPLIZNA (n=161) vs 35% with placebo (n=52)5

  • The EDSS analysis included visits during an attack, with EDSS progression driven by the expected increase in EDSS at the time of attack. Therefore, these results should not be interpreted as impacting disability independent of attack reduction. Additionally, subjects were not followed up for the same amount of time, resulting in missing data which may have introduced biases into the analysis. Subjects with missing data are imputed as worsening.4

‡‡Worsening disability was assessed by the EDSS at last visit during the RCP, defined as (1) worsening of 2 or more points in EDSS score for subjects with baseline score of 0; (2) worsening of 1 or more points in EDSS score for subjects with baseline score of 1 to 5; (3) or worsening of 0.5 points or more in EDSS score for subjects with baseline score of 5.5 or more.4

Inpatient hospitalization and EDSS results through 2.5+ years6

  • Hospitalizations
  • Disability
Chart comparing UPLIZNA® to placebo, showing rates of inpatient hospitalization and changes in EDSS scores Chart comparing UPLIZNA® to placebo, showing rates of inpatient hospitalization and changes in EDSS scores
Chart comparing UPLIZNA® to placebo, showing rates of disability and changes in EDSS scores Chart comparing UPLIZNA® to placebo, showing rates of disability and changes in EDSS scores

Consider open-label treatment phase study limitations when interpreting results. The OLP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. During the OLP, a total of 42 patients (19.4%) discontinued, of which 5 patients (2.3%) discontinued due to adverse events.2,‡,§

  • Over 2.5+ years, UPLIZNA patients had fewer NMOSD-related hospitalizations vs placebo in the RCP3
Icons 8

Consider open-label treatment phase study limitations when interpreting results. The OLP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. During the OLP, a total of 42 patients (19.4%) discontinued, of which 5 patients (2.3%) discontinued due to adverse events.2,‡,§

‡Includes both AQP4-IgG+ and AQP4-IgG negative patients.

§Compared to placebo in the RCP. Data from a post hoc analysis of N-MOmentum conducted by JL Bennett et al.

Twice-yearly§§ dosing with UPLIZNA1

Offering patients 6 months of infusion-free time

§§Following 2 initial doses 2 weeks apart.
Safety and Tolerability
AAR, annualized attack rate; AQP4-lgG+, aquaporin-4 immunoglobulin G+; Cl, confidence interval; EDSS, Expanded Disability Status Scale; HR, hazard ratio; ITT, intent to treat; NMOSD, neuromyelitis optica spectrum disorder; OLP, open-label period; RCP, randomized controlled period.

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: Infusion reactions, including anaphylaxis, can occur. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods (RCPs) of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively. 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: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA. The most common infections reported by UPLIZNA-treated patients in the NMOSD randomized and open-label clinical trial periods for NMOSD were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection, influenza, and pneumonia. In the gMG RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection and nasopharyngitis. Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been observed with B-cell-depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies. HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial and in the postmarketing setting. Patients with active or 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 HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for HBsAg and positive for HBcAb, or who are carriers of HBV (i.e., 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 (at least 10% of patients treated with UPLIZNA and greater than placebo): urinary tract infection and arthralgia in NMOSD; urinary tract infection and lymphopenia in IgG4-RD; headache and infusion-related reactions in gMG.

INDICATIONS

UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive (Ab+) generalized myasthenia gravis (gMG).

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: Infusion reactions, including anaphylaxis, can occur. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods (RCPs) of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively. 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: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA. The most common infections reported by UPLIZNA-treated patients in the NMOSD randomized and open-label clinical trial periods for NMOSD were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection, influenza, and pneumonia. In the gMG RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection and nasopharyngitis. Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been observed with B-cell-depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies. HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial and in the postmarketing setting. Patients with active or 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 HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for HBsAg and positive for HBcAb, or who are carriers of HBV (i.e., 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 (at least 10% of patients treated with UPLIZNA and greater than placebo): urinary tract infection and arthralgia in NMOSD; urinary tract infection and lymphopenia in IgG4-RD; headache and infusion-related reactions in gMG.

INDICATIONS

UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive (Ab+) generalized myasthenia gravis (gMG).

Please see UPLIZNA Full Prescribing Information.

  • REFERENCES:
    1. UPLIZNA® (inebilizumab-cdon) prescribing information, Amgen.
    2. Cree BAC, Kim HJ, Weinshenker BG, et al. Lancet Neurol. 2024;23:588-602.
    3. Bennett JL, Aktas O, Rees WA, et al. EBioMedicine. 2022;86:104321.
    4. Cree BAC, Bennett JL, Kim HL, et al. Lancet. 2019;394:1352-1363.
    5. Data on File. Amgen, 2021.
    6. Cree BAC, Kim HJ, Weinshenker BG, et al. Lancet Neurol [supp]. 2024;23:588-602.