SOLIRIS EFFICACY IN NMOSD

SOLIRIS® (eculizumab) significantly reduced the risk of relapse by 94% vs placebo in PREVENT

PREVENT

PREVENT OLE

Primary endpoint

The PREVENT study demonstrated that SOLIRIS is superior to placebo based on time to first adjudicated relapse (P<0.0001)1

94% reduction in risk of relapse
94% reduction in risk of relapse

The time to first adjudicated on-trial relapse was significantly longer in SOLIRIS-treated patients compared to patients on placebo (relative risk reduction, 94%; HR=0.058; 95% CI: 0.017, 0.197; P<0.0001).

Percentage of patients who were relapse-free infographic

Abbreviations: CI, confidence interval; HR, hazard ratio.

Kaplan-Meier plot shows time to first adjudicated relapse among patients receiving SOLIRIS or placebo for anti-AQP4 antibody-positive NMOSD in the analysis of the primary endpoint modified intent-to-treat population. Patients who did not experience an adjudicated on-trial relapse were censored at the end of the study period.1,2

Secondary endpoint

Significant relative reduction in on-trial adjudicated ARR1,2

Adjudicated ARR and Number of Adjudicated On-Trial Relapses with Soliris vs Placebo graph
Adjudicated ARR and Number of Adjudicated On-Trial Relapses with Soliris vs Placebo graph

SOLIRIS impact on relapse hospitalization and acute treatments

Compared to placebo, patients treated with SOLIRIS had reductions in annualized rates of1:

Soliris had reductions in annualized rates of compared to placebo
Soliris had reductions in annualized rates of compared to placebo

Abbreviation: IV, intravenous.

Additional prespecified analyses from the PREVENT study

Percentage of patients who were relapse-free at 96 and 144 weeks2

96 percent of patients were relapse-free at 96 weeks and 144 weeks
96 percent of patients were relapse-free at 96 weeks and 144 weeks

Study limitations: 96- and 144-week data

  • The time to first adjudicated on-trial relapse at weeks 96 and 144 was evaluated in a prespecified analysis2,3
  • The PREVENT study did not include enough patients beyond week 48 to determine whether a difference in time to the first adjudicated on-trial relapse between the 2 treatment groups at weeks 96 and 144 is statistically significant or clinically meaningful

Percentage of patients who were relapse-free on monotherapy2

100% of Soliris-treated patients were relapse free at 48 weeks
100% of Soliris-treated patients were relapse free at 48 weeks

Study limitations: monotherapy subgroup

  • The monotherapy subgroup analysis is exploratory, and it did not have enough patients to establish conclusions of benefit
  • During the treatment phase of the PREVENT study, 76% of patients (n=109) received concomitant immunosuppressive therapy, including chronic corticosteroids; 24% of patients (n=34) did not receive concomitant immunosuppressive therapy or chronic corticosteroids during the treatment phase of the study (monotherapy)1,2

PREVENT OLE study limitations

The primary goal of the PREVENT OLE was to evaluate the long-term safety of SOLIRIS in adult patients with anti-AQP4 antibody-positive NMOSD. To view these data, click here.

Please note any inference of efficacy or clinical significance should be interpreted with caution since the study was open-label and lacked a control group.

Secondary objective4

In PREVENT OLE, evaluation of the efficacy of SOLIRIS was a secondary objective

The primary efficacy endpoint was ARR based on the number of on-trial relapses identified by the treating physician and time in the study period.

On-Trial ARR (As Determined by the Treating Physician) Accounting for COVID-19 Disruption of Study Treatment – Extension Full Analysis Set

Variable Statistic Total
(N=119)
Historicala patient ARRb
Mean (SD)
Median
Min, max
2.013 (0.9932)
1.923
0.96, 6.38
Patient on-trial ARR in PREVENT OLEb
Mean (SD)
Median
Min, max
0.084 (0.3212)
0.000
0.00, 2.46
Change in ARR between historical ARR and PREVENT OLE on-trial ARR
Mean (SD)
Median
Min, max
95% CI for mean
-1.929 (1.0324)
-1.825
-6.38, 1.02
(-2.116, -1.741)

For patients who missed 2 or more doses consecutively due to COVID-19–related reasons, the time period for the calculation of PREVENT OLE on-trial ARR excludes the time period when the patient missed SOLIRIS infusion to account for the impact of the pandemic. Any relapse occurring during this period was not included in the calculation of PREVENT OLE on-trial ARR.
aBased on 24 months prior to screening in PREVENT study.
bThe number of relapses for each patient divided by the number of years in the study period for that patient; summary statistics across all patients are presented.
Abbreviation: COVID-19, coronavirus disease of 2019.

Primary Analysis: Kaplan-Meier Survival Estimates for Time to First On-Trial Relapse (As Determined by the Treating Physician) in PREVENT OLE Censored for COVID-19 Disruption of Study Treatment

Percentage of patients who were relapse-free infographic

Note: Patients who did not experience an on-trial relapse as determined by the treating physician were censored at the end of the study period.

For patients who missed 2 or more doses consecutively due to COVID-19–related reasons, the study period was truncated to the last dose date prior to missing 2 or more infusions consecutively due to COVID-19–related reasons + 16 days (or + 9 days if in induction phase), and patients who did not experience an on-trial relapse were censored at this date. Estimated proportion of patients relapse-free was only presented when the number of patients at risk in the total group at the time point was at least 5.

aBased on the Kaplan-Meier product limit method.
bBased on the complementary log-log transformation.

One hundred six (89.1%) patients in the PREVENT OLE did not experience an on-trial relapse during the study. Of the 13 patients who experienced an on-trial relapse (as determined by the treating physician), 9 patients had 1 relapse, 1 patient had 2 relapses, and 3 patients had 3 relapses.

An additional 2 patients each experienced 1 on-trial relapse as determined by the treating physician during a dose interruption due to COVID-19; both of these relapses were adjudicated positively. Sensitivity analyses, including these 2 relapses, were consistent with those of the primary analyses, which accounted for COVID-19 disruption of study treatment.

Sensitivity Analysis: Kaplan-Meier Survival Estimates for Time to First Adjudicated On-Trial Relapse in PREVENT OLE Censored for COVID-19 Disruption of Study Treatment

Percentage of patients who were relapse-free infographic

Note: Patients who did not experience an adjudicated on-trial relapse were censored at the end of the study period.

For patients who missed 2 or more doses consecutively due to COVID-19–related reasons, the study period was truncated to the last dose date prior to missing 2 or more doses consecutively due to COVID-19–related reasons + 16 days (or + 9 days if in induction phase), and patients who did not experience an adjudicated on-trial relapse were censored at this date. Estimated proportion of relapse-free patients was only presented when the number of patients at risk in the total group at a time point was at least 5.

aBased on the Kaplan-Meier product limit method.
bBased on the complementary log-log transformation.

One hundred thirteen (95.0%) patients in PREVENT OLE did not experience an adjudicated on-trial relapse during the study. Of the 6 patients who experienced an adjudicated on-trial relapse, 5 had 1 adjudicated relapse and 1 had 2 adjudicated relapses.

An additional 2 patients each experienced 1 on-trial relapse as determined by the treating physician during a dose interruption due to COVID-19; both of these relapses were adjudicated positively. Sensitivity analyses, including these 2 relapses, were consistent with those of the primary analyses, which accounted for COVID-19 disruption of study treatment. These 2 relapses are not reflected in this Kaplan-Meier Survival Estimate figure.

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IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING

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WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection).
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

Contraindications
  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection
Warnings and Precautions
Serious Meningococcal Infections
Risk and Prevention

The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). 

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.

Infusion-Related Reactions

Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. 

Adverse Reactions

The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

INDICATION
Neuromyelitis Optica Spectrum Disorder (NMOSD)

Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Please see full Prescribing Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection).
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

Contraindications
  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection
Warnings and Precautions
Serious Meningococcal Infections
Risk and Prevention

The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). 

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.

Infusion-Related Reactions

Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. 

Adverse Reactions

The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

INDICATION
Neuromyelitis Optica Spectrum Disorder (NMOSD)

Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Please see full Prescribing Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

References
1. SOLIRIS. Prescribing information. Alexion Pharmaceuticals, Inc. 2. Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(7):614-625. doi:10.1056/NEJMoa1900866 3. Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(7)(suppl 1-36):614-625. doi:10.1186/1742-2094-9-14 4. Data on file. Alexion Pharmaceuticals, Inc.

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