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Efficacy

Images are not of actual patients

ULTOMIRIS® efficacy data from CHAMPION-MG

Primary Endpoint

See Trial Design

See Safety

ULTOMIRIS is proven to deliver improvement in MG-Activities of Daily Living (MG-ADL) in patients with generalized myasthenia gravis (gMG)1,2

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

ULTOMIRIS demonstrated efficacy vs placebo at Week 26 (-3.1 vs -1.4, respectively [P <0.001])1,3

Line chart showing at 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% confidence intervals (CIs), using a mixed model for repeated measures; 95% CIs were not adjusted for multiplicity.

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.

Watch: gMG Expert Explores ULTOMIRIS Efficacy and Safety

Secondary Endpoints

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

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 <0.001])1,3

Line chart showing 3.5 times 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 26.4

CHAMPION-MG STUDY LIMITATION: Change from baseline in QMG individual symptom domains was an exploratory endpoint. Efficacy or clinical significance should be interpreted with caution.

MG-ADL total score observed through Week 164 in the OLE period5

Improvement in MG-ADL total score in CHAMPION-MG was observed through Week 164 in the open-label extension (OLE) period5

Line chart showing MG-ADL total score observed through Week 164 in the open label extension period. Patients who completed the randomized-controlled period had the option to enter the OLE.

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.

QMG total score observed through Week 164 in the OLE period5

Improvement in QMG total score in CHAMPION-MG was observed through Week 164 in the open-label extension (OLE) period5

Line chart showing QMG total score observed through week 164 in the open label extension period. Through week 164, patients on ULTOMIRIS experienced a 4.3-point mean improvement from baseline.

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

Download: MG-ADL Scale

Download: QMG Scale

Additional secondary endpoints for QMG total score at Week 261

Observed improvements 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 score3

Bar graphs showing that 3 times 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 wasn’t considered for statistical significance

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

Post Hoc Analyses

MG-ADL total score

Patients who started ULTOMIRIS within 2 years of gMG diagnosis were observed to have experienced a 4.3-point reduction in MG-ADL total scores from baseline. Patients who started after 2 years were observed to have experienced a 2.9-point reduction.6,a,b

Time from MG diagnosis to starting ULTOMIRIS6,a

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. Differences between the two ULTOMIRIS arms were not statistically significant. Results and clinical outcomes should be interpreted with caution.

aThe numbers of patients indicated in the figure are the numbers of patients included in the MMRM analysis. MG-ADL data were available at both baseline and 26 weeks for 30 patients in the ≤2-years subgroup (17 receiving ravulizumab, 13 receiving placebo) and 130 patients in the >2-years subgroup (61 receiving ravulizumab, 69 receiving placebo). The MMRM analysis used all available longitudinal data for inference, assuming missing at random for missing assessments. Estimates are based on MMRM that includes treatment group, stratification factor region, age at baseline and MG-ADL total score at baseline, study visit, study visit by treatment group interaction, time from diagnosis by treatment group, time from diagnosis by study visit interaction, and time from diagnosis by study visit by treatment group interaction.6

bIn a post hoc analysis of 175 patients at Week 26.6

Baseline demographics and clinical characteristics by time from MG diagnosis6

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

cIncluding corticosteroids; no patients were being treated with >2 ISTs and no patients were being treated with >1 NSIST.6

Corticosteroid use

Corticosteroid use was observed in the OLE

The change in corticosteroid use was assessed (N=113). Dose changes were only allowed in the OLE period beginning after Week 26 of CHAMPION-MG.7

Changes in daily corticosteroid doses during the OLE (all patients who were receiving corticosteroids at OLE start)5,7,d

Bar graph showing changes in daily corticosteroid doses during the open label extension period and that 3 times the number of patients were taking ≥5 mg/day of corticosteroids by the end of the OLE
  • At the first reported dose, 11/113 (9.7%) and 47/113 (41.6%) patients were receiving ≤5 mg/day or ≤10 mg/day, respectively7,f
  • At last reported dose, 35/113 (31.0%) and 71/113 (62.8%) patients were receiving ≤5 mg/day or ≤10 mg/day, respectively7,f
  • In an ongoing analysis with no comparator group, the percentage of patients who increased corticosteroid use was 5.6% (9/161). 2.5% of patients (4/161) initiated corticosteroid use through Week 602

Mean (SD) daily dose of corticosteroids7:

  • First OLE dosage: 17.5 (11.9) mg/day
  • Last reported dosage: 11.7 (10.9) mg/dayd

d99% of patients (112/113) were taking corticosteroids at the beginning of the OLE.5

eMedian duration of treatment (RCP+OLE) was 759 days (14-1265). Data utilized was from last reported dose.5

fMedian duration of treatment (RCP+OLE) was ~108 weeks (2-180.71 weeks). Data utilized was from last reported dose.7

CHAMPION-MG OLE STUDY LIMITATIONS: Corticosteroid use was not a prespecified endpoint. Results or clinical outcomes should be interpreted with caution since the study was designed to evaluate safety and lacked a control group. The study was not designed to assess corticosteroid use or outcomes.

Cumulative MG-ADL response

Cumulative MG-ADL responseg rates in ULTOMIRIS-treated patients—60-week cutoff8,h

Bar graph showing cumulative MG-ADL response rates over time in ULTOMIRIS-treated patients. By Week 164, 80% of ULTOMIRIS-treated patients experienced a ≥3-point improvement in MG-ADL total score from baseline. Response not achieved by data cutoff in 18%.

In an additional 164-week analysis: 80% (128/160) of patients treated with ULTOMIRIS experienced a ≥3-point improvement in MG-ADL total score from baseline5,j

gResponse was defined as improvement in MG-ADL total score ≥3 points from baseline; based on data from 139 patients treated with ULTOMIRIS for up to 60 weeks.8

hThe cumulative response rate was conservatively calculated using the total sample size (N=139) as the denominator for all study visits.8

iDate of data cutoff: November 9, 2021.8

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

MG-ADL, Myasthenia Gravis Activities of Daily Living.

CHAMPION-MG OLE STUDY LIMITATIONS: Cumulative MG-ADL response was not a prespecified endpoint. Results or clinical outcomes should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.

Minimal symptom expression (MSE)k observed through Week 1645

Cumulative Proportions of Respondersl,m by Week 164 (N=160)5

43% of patients achieved minimal symptom expression while 80% of patients experienced a ≥3-point improvement in MG-ADL

CHAMPION-MG OLE STUDY LIMITATIONS: Minimal symptom expression was not a prespecified endpoint. Results or clinical outcomes should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.

kMSE is defined as MG-ADL score of O or 1.5

lMG-ADL responder analysis is defined as the proportion of patients achieving an improvement from baseline of 3 points or more.3

mAnalysis excludes patients who received placebo and had MSE during the RCP.5

Exploratory Endpoint

Clinical deterioration observations2

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,n

Clinical deterioration events per 100 patient-years2,o

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 OLE STUDY LIMITATIONS: Clinical deterioration was a prespecified endpoint. Results or clinical outcomes should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.

nULTOMIRIS event rate is based on combined RCP and OLE data. Placebo event rate is based on RCP data only.2

oClinical 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

p1-year prestudy period, events reported by investigators. Patients may have been on other medications to treat generalized myasthenia gravis during this period.2

ADA, anti-drug antibody; BL, baseline; IST, immunosuppressive therapy; LLOQ, lower limit of quantification; LS, least squares; MG, myasthenia gravis; MGFA, Myasthenia Gravis Foundation of America; MG-QoL15r, myasthenia gravis Quality of Life 15-item scale; Neuro-QoL, Neurological Disorders Quality of Life; MMRM, mixed model for repeated measures; NSIST, nonsteroidal immunosuppressive therapy; QMG, Quantitative Myasthenia Gravis; RCP, randomized-controlled period; SD, standard deviation; SEM, standard error of the mean.

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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)].

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
Administration of ULTOMIRIS 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, including lower back pain, abdominal pain, muscle spasms, drop or elevation in blood pressure, rigors, limb discomfort, drug hypersensitivity (allergic reaction), and dysgeusia (bad taste). These reactions did not require discontinuation of ULTOMIRIS. If signs of cardiovascular instability or respiratory compromise occur, interrupt ULTOMIRIS 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.

USE IN SPECIFIC POPULATIONS
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ULTOMIRIS during pregnancy. Healthcare providers and patients may call 1-833-793-0563 or go to www.UltomirisPregnancyStudy.com to enroll in or to obtain information about the registry.

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.

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

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

References:

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