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Efficacy

Images are not of actual patients

ULTOMIRIS® efficacy data from CHAMPION-MG

Primary Endpoint

ULTOMIRIS is proven to deliver improvement in activities of daily living in patients with generalized myasthenia gravis (gMG)1,2

Among patients in the ULTOMIRIS (ravulizumab-cwvz) treatment arm,
Improvements in myasthenia gravis activities of daily living (MG-ADL) total scores from baseline were observed within 1 week of treatment and were sustained through Week 26 of treatment.1

MG-ADL Scale

ULTOMIRIS demonstrated efficacy vs placebo at Week 26 (-3.1 vs -1.4, respectively [P=0.0009])1,3

26 week MG-ADL improvement with ULTOMIRIS was twice as great as placebo

CHAMPION-MG STUDY LIMITATIONS: Data shown are least-squares means and 95% Cls, using a mixed model for repeated measures; 95% CIs were not adjusted for multiplicity.1,3

Time to response was part of the planned efficacy analysis, but the primary endpoint was at Week 26. Therefore, results should be interpreted with caution.

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Secondary Endpoints

Improvement in muscle strength demonstrated by QMG total score from baseline through Week 261,3

QMG Scale

Improvement was shown in the key secondary endpoint, patients' QMG total score through Week 26 (-2.8 points for ULTOMIRIS vs -0.8 points for placebo [P=0.0009])1,3

line chart showing 3.5x greater improvement vs placebo in QMG at 26 weeks

Improvements in QMG scores were seen across the ocular, bulbar, and limb domain scores from baseline to Week 26.3

  • CHAMPION-MG STUDY LIMITATION: Change from baseline in QMG individual symptom domains was an exploratory endpoint. Results and clinical outcomes should be interpreted with caution

MG-ADL total score observed through Week 60 in the OLE period2

Improvement in MG-ADL total score seen in CHAMPION-MG was observed through Week 60 in the OLE period2

The OLE period began following Week 26, when all patients received ULTOMIRIS, and results were observed through Week 60.2

line chart showing a change from baseline MG-ADL score of 1.7 in people previously taking placebo and of 4.8 in people previously taking ULTOMIRIS during the OLE at 60 weeks
MG-ADL Scale

CHAMPION-MG OLE STUDY LIMITATION: Results and clinical outcomes should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.

This graph is adapted from Meisel A, Annane D, Vu T, et al. J Neurol, 2023, modified from its original presentation, and is used under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.

QMG total score observed through Week 60 in the OLE period2

Improvement in QMG total score seen in CHAMPION-MG was observed through Week 60 in the OLE period2

The OLE period began following Week 26, when all patients received ULTOMIRIS, and results were observed through Week 60.2

line chart showing QMG in OLE at 60 weeks
QMG Scale

CHAMPION-MG OLE STUDY LIMITATION: Results and clinical outcomes should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.

This graph is adapted from Meisel A, Annane D, Vu T, et al. J Neurol, 2023, modified from its original presentation, and is used under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.

Additional secondary endpoints for QMG total score at Week 261

Observed improvement in QMG with ULTOMIRIS1

The proportion of patients taking ULTOMIRIS who achieved a ≥5-point improvement in QMG total score was greater than the proportion of patients taking placebo.1

30% of patients taking ULTOMIRIS had a ≥5-point improvement in QMG total score vs 11.3% taking placebo (P=0.005).1

Patients treated with ULTOMIRIS were more likely to experience a larger improvement in QMG total score4

bar graphs showing that 3x as many patients on ULTOMIRIS as on placebo experienced QMG total score improvement of more than 5 points

Additional secondary endpoints related to quality of life in CHAMPION-MG3

  • Change from baseline to Week 26 in MG-QoL15r: -3.3 for ULTOMIRIS and -1.6 for placebo
  • Change from baseline to Week 26 in the Neuro-QoL Fatigue score: -7.0 for ULTOMIRIS and -4.8 for placebo
  • MG-QoL15r didn’t reach statistical significance. Due to hierarchical testing, Neuro-QoL and ≥3 point improvement in MG-ADL total score were not considered statistically significant

Observed MG-ADL total score changes with ULTOMIRIS1,3

  • More patients taking ULTOMIRIS achieved a ≥3-point improvement in MG-ADL total score vs placebo
  • 57% of patients taking ULTOMIRIS had a ≥3-point improvement in MG-ADL total score vs 34% of patients taking placebo. Due to hierarchical testing, ≥3 point improvement in MG-ADL total score was not considered statistically significant

Exploratory Endpoints and Post Hoc Analyses

Improvements observed in a range of exploratory endpoints and post hoc analyses

MG-ADL total score reduction with earlier use

Patients who started ULTOMIRIS within 2 years of gMG diagnosis experienced a 4.3-point reduction in MG-ADL total scores from baseline, while patients who started after 2 years experienced a 2.9-point reduction.5,a

aIn a post hoc analysis of 175 patients at Week 26.5

Time From MG Diagnosis to Starting ULTOMIRIS5

bar graphs showing that patients who started ULTOMIRIS within 2 years of gMG diagnosis experienced a 4.3-point reduction in MG-ADL total scores from baseline, while patients who started after 2 years experienced a 2.9-point reduction.

CHAMPION-MG STUDY LIMITATION: Change in MG-ADL total score reduction with earlier use was not a prespecified endpoint. Results and clinical outcomes should be interpreted with caution.5

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View Baseline Demographics and Clinical Characteristics
Patient characteristics of those who started ULTOMIRIS before and after 2 years of gMG diagnosis, including their MG-ADL and QMG scores

bIncluding corticosteroids; no patients were being treated with >2 ISTs and no patients were being treated with >1 NSIST.5

Cumulative MG-ADL response

By Week 60, 82% of patients treated with ULTOMIRIS experienced a ≥3-point improvement in MG-ADL total score from baseline.6,c,d

cn=139 at data cutoff. Date of data cutoff: November 9, 2021.2,3,6

dResponse defined as improvement from baseline in MG-ADL total score ≥3 points.6

Cumulative MG-ADL Response Rates Over Time in ULTOMIRIS-Treated Patients6

bar graph showing cumulative MG-ADL response rates over time

CHAMPION-MG STUDY LIMITATION: Cumulative MG-ADL response was not a prespecified endpoint. Results and clinical outcomes should be interpreted with caution.

Pharmacokinetic (PK) and Pharmacodynamic (PD) Analysis1,7

Complete terminal complement inhibition was observed as of study Day 1 and was shown throughout 26 weeks for 100% of patients

No inferences of efficacy or safety can be made from this data.

  • Administration of ULTOMIRIS achieved immediate and complete terminal complement inhibition (serum free C5 <0.5 μg/mL)
  • Free C5 concentrations below LLOQ were analyzed as 0.00915 μg/mL
  • Mean baseline serum free C5 concentration (pre-dose) was 153.6 (SD 37.0) μg/mL
  • ADA titers were low and transient, with no apparent effect on PK or PD

The PK/PD data support the use of ULTOMIRIS every 8 weeks for immediate, complete, and sustained inhibition of C5.

ULTOMIRIS starts C5 inhibition as early as Day 17

Expanded PK and PD data for ULTOMIRIS

This graphic is adapted from Vu T, et al. J Neurol. Published online March 9, 2023. doi:10.1007/s00415-023-11617-1

Download the Clinical Pharmacology Brochure

Reduction in clinical deterioration events

Patients receiving ULTOMIRIS experienced clinical deteriorations at an event rate of 17.8 events per 100 patient-years vs 61.6 events per 100 patient-years in patients receiving placebo.2,e

Clinical Deterioration Events per 100 Patient-Years2,f

bar graph showing reduction in clinical deterioration events: 61.6 per 100 patient-years for patients on placebo vs 17.8 for those on ULTOMIRIS

This graphic is adapted from Meisel A, Annane D, Vu T, et al. J Neurol, 2023, modified from its original presentation, and is used under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.

CHAMPION-MG STUDY LIMITATION: Clinical deterioration was not a prespecified endpoint. Results and clinical outcomes should be interpreted with caution.

eULTOMIRIS event rate is based on combined RCP and OLE data. Placebo event rate is based on RCP data only. Event rate was calculated using the effectiveness analysis data set (N=161).2

fClinical deterioration was defined as myasthenic crisis, need for rescue therapy, or significant symptom worsening on any MG-ADL item, other than double vision or eyelid droop.2

g1-year prestudy period, events reported by investigators. Patients may have been on other medications to treat gMG during this period.2

MGFA post-intervention status: minimal manifestation observed at Week 263

1 in 4 patients treated with ULTOMIRIS achieved minimal manifestation status vs 1 in 10 on placebo.3

Patients achieving minimal manifestation status: ULTOMIRIS: 25%. Placebo: 10%.

Minimal manifestation status is achieved when a patient has no symptoms of functional limitations from MG but has some weakness on examination of some muscles. It’s another way to assess a patient’s symptoms after treatment initiation.8,h,i

Patients reaching minimal manifestation status may be better able to perform everyday activities.8

CHAMPION-MG STUDY LIMITATION: Minimal manifestation was an exploratory endpoint. Results and clinical outcomes should be interpreted with caution.3

hPer MGFA post-intervention status.8

iThis class recognizes that some patients who otherwise meet the definition of pharmacologic remission do have weakness that is only detectable by careful examination.8

Corticosteroid use

In an interim analysis, 28% of patients reduced and 6.2% of patients stopped steroid use during the 34-week OLE period (45 and 10 patients, respectively)2,j-m

ULTOMIRIS is the first and only long-acting C5 inhibitor to report on corticosteroid use.

More than 34% of patients on ULTOMIRIS reported a decrease in use or discontinuation of corticosteroids

The percentage of patients who increased corticosteroid use was 5.6% (9/161), and 2.5% of patients (4/161) initiated corticosteroid use.

Learn More About Corticosteroid Data

CHAMPION-MG OLE STUDY LIMITATION: Any inference of efficacy or clinical significance should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.

jBased on a prespecified interim analysis, N=161.2,3

kDose changes were only allowed in the OLE period beginning after Week 26 of the RCP.2,3

lDate of data cutoff: November 9, 2021.2,3

mBy Week 60, 8% of patients increased their daily dose of corticosteroids or added steroids to their treatment regimen. Percentages based on all patients in the OLE, not just those on steroids.2

ADA, anti-drug antibody; BL, baseline; CI, confidence interval; gMG, generalized myasthenia gravis; IST, immunosuppressive therapy; LLOQ, lower limit of quantitation; LS, least squares; MG, myasthenia gravis; MG-ADL, Myasthenia Gravis Activities of Daily Living; MGFA, Myasthenia Gravis Foundation of America; MG-QoL15r, Myasthenia Gravis Quality of Life 15-item scale; Neuro-QoL, Neurological Disorders Quality of Life; NSIST, nonsteroidal immunosuppressive therapy; OLE, open-label extension; QMG, Quantitative Myasthenia Gravis; RCP, randomized-controlled period; SD, standard deviation.

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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

ULTOMIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1)] Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

  • Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.
  • Patients receiving ULTOMIRIS are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2)].

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CONTRAINDICATIONS

  • Initiation in patients with unresolved serious Neisseria meningitidis infection.

WARNINGS AND PRECAUTIONS

Serious Meningococcal Infections

ULTOMIRIS, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.

Revaccinate patients in accordance with ACIP recommendations considering the duration of ULTOMIRIS therapy. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent ULTOMIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including ULTOMIRIS. The benefits and risks of treatment with ULTOMIRIS, as well as those associated with antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by Neisseria meningitidis.

Vaccination does not eliminate the risk of serious meningococcal infections, despite development of antibodies following vaccination.

Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if they occur. Promptly treat known infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection depending on the risks of interrupting treatment in the disease being treated.

ULTOMIRIS and SOLIRIS REMS
Due to the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program called ULTOMIRIS and SOLIRIS REMS.

Prescribers must enroll in the REMS, counsel patients about the risk of serious meningococcal infection, provide patients with the REMS educational materials, assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y, and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of ULTOMIRIS. Antibacterial drug prophylaxis must be prescribed if treatment must be started urgently, and the patient is not up to date with both meningococcal vaccines according to current ACIP recommendations at least two weeks prior to the first dose of ULTOMIRIS. Patients must receive counseling about the need to receive meningococcal vaccines and to take antibiotics as directed, signs and symptoms of meningococcal infection, and be instructed to carry the Patient Safety Card at all times during and for 8 months following ULTOMIRIS treatment.

Further information is available at www.UltSolREMS.com or 1-888-765-4747.

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

ULTOMIRIS blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Patients receiving ULTOMIRIS are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Thromboembolic Event Management
The effect of withdrawal of anticoagulant therapy during treatment with ULTOMIRIS has not been established. Treatment should not alter anticoagulant management.

Infusion-Related Reactions
Intravenous administration may result in systemic infusion-related reactions, including anaphylaxis and hypersensitivity reactions. In clinical trials, infusion-related reactions occurred in approximately 1 to 7% of patients treated with ULTOMIRIS. These events included lower back pain, drop in blood pressure, limb discomfort, drug hypersensitivity (allergic reaction), dysgeusia (bad taste), and drowsiness. These reactions did not require discontinuation of ULTOMIRIS. If signs of cardiovascular instability or respiratory compromise occur, interrupt ULTOMIRIS infusion and institute appropriate supportive measures.

ADVERSE REACTIONS
Most common adverse reactions in adult patients with gMG (incidence ≥10%) were diarrhea and upper respiratory tract infection. Serious adverse reactions were reported in 20 (23%) of patients treated with ULTOMIRIS and in 14 (16%) patients receiving placebo. The most frequent serious adverse reactions were infections reported in at least 8 (9%) patients treated with ULTOMIRIS and in 4 (4%) patients treated with placebo. Of these infections, one fatal case of COVID-19 pneumonia was identified in a patient treated with ULTOMIRIS and one case of infection led to discontinuation of ULTOMIRIS.

DRUG INTERACTIONS
Plasma Exchange, Plasmapheresis, and Intravenous Immunoglobulins
Concomitant use of ULTOMIRIS with plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg) treatment can reduce serum ravulizumab concentrations and requires a supplemental dose of ULTOMIRIS.

Neonatal Fc Receptor Blockers
Concomitant use of ULTOMIRIS with neonatal Fc receptor (FcRn) blockers (e.g., efgartigimod) may lower systemic exposures and reduce effectiveness of ULTOMIRIS. Closely monitor for reduced effectiveness of ULTOMIRIS.

INDICATION
ULTOMIRIS is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.

References:

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