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Efficacy

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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)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 sustained through Week 26.1,2,a

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

Line chart showing at 26 weeks MG-ADL improvement with ULTOMIRIS was twice as great as placebo

Many patients continued with concomitant medications for gMG throughout the 26 weeks of the study.1,2

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.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.

MG-ADL is a patient-reported, 8-item assessment reflecting functional impairment of ocular, bulbar, respiratory, and limb symptoms with a maximum total score of 24.4

Secondary Endpoints

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

ULTOMIRIS demonstrated 3.5x greater improvement vs placebo in the key secondary endpoint, change from baseline in 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 265

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

Reduction in MG-ADL total score in CHAMPION-MG was observed in the open-label extension (OLE) period through Year 32

Reduction in MG-ADL total score observed through Year 32

Line chart showing MG-ADL total scores observed through Week 164 in the open-label extension (OLE) period. Through Week 164, patients on ULTOMIRIS experienced a 4-point reduction in MG-ADL total scores

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.

Reduction observed when switching from placebo to ULTOMIRIS following Week 262

  • 2.1-point reduction after 138 weeks (at Week 164 in CHAMPION-MG OLE)2

The OLE period began following Week 26, when all patients received ULTOMIRIS and results were observed through Week 164. Patients who completed the RCP had the option to enter the OLE.2

Reduction in QMG total score observed through 3 years in the OLE2

Line chart showing QMG total scores observed through Week 164 in the open-label extension (OLE) 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.

Observed improvements in QMG total score at Week 261

Patients treated with ULTOMIRIS were more likely to experience a larger improvement in QMG total score1

Reduction 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

The proportion of patients taking ULTOMIRIS who achieved a ≥5-point improvement in QMG total score at Week 26 was greater than the proportion of patients taking placebo.1

30% of patients taking ULTOMIRIS had a ≥5-point improvement in QMG total score at Week 26 vs 11.3% taking placebo (P=0.005).1

Endpoints related to quality of life3

  • 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.a

aDue to hierarchical testing, ≥3‐point improvement in MG-ADL total score was not considered statistically significant.3

Post hoc subgroup analyses

Impact of early use of ULTOMIRIS on MG-ADL total score changes

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 mean reduction in MG-ADL total scores from baseline, while patients who started after 2 years experienced a 2.9-point mean reduction

CHAMPION-MG STUDY LIMITATION: Change in MG-ADL total score reduction with earlier use was not a prespecified endpoint. Differences between the 2 ULTOMIRIS arms were not statistically significant. Results and clinical outcomes should be interpreted with caution.2

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-year subgroup (17 receiving ravulizumab, 13 receiving placebo) and 130 patients in the >2-year 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, 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 baseline MG-ADL and QMG scores

aIncluding 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=112). Dose changes were only allowed in the OLE period beginning after Week 26 of CHAMPION-MG.2

Changes in corticosteroid use in the OLE2,a,b

Stacked bar chart showing corticosteroid dose use over time from Day 1 through Month 24 and last assessment

aAll patients who were receiving corticosteroids at OLE start.2

bLast assessment is the final participant study visit during which outcomes were measured.2

Changes in corticosteroid use in the OLE

Proportion of patients receiving steroids during the OLE2,a

Table showing the percentage of patients receiving steroids during the open-label extension (OLE) at Day 1, Month 24, and last assessment. Use of ≤10 mg/day increased from 41% to 63%, ≤5 mg/day from 9% to 31%, and 0 mg/day from 1% to 12%

aOf those who were receiving corticosteroids at OLE start.

Mean (SD) daily dose of corticosteroids2:

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

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

MG-ADL response through Week 164

MG-ADL total score reductions during the OLE were observed among ravulizumab responders2

Circular chart showing 77.2% (n=71) of participants had a ≥2-point reduction, and 67.3% (n=68) had a ≥3-point reduction, both sustained for >75% of the remaining time in the OLE after first response

aPatients in the placebo arm who had the corresponding response during the RCP were excluded.2

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.

MG-ADL responders and MSE observed through Week 164

Minimal Symptom Expression (MSE) was observed2,a

MSE = MG-ADL score of 0 or 1

88% of patients experienced a ≥2-point reduction from MG-ADL total score (at any point) during the study. Of those attaining a ≥2-point reduction in MG-ADL total score, 42% experienced MSE (at any point) during the study. 54% of patients maintained MSE for more than half of their remaining time in the randomized controlled period and OLE

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.

aNine patients in the placebo group who achieved MSE during the RCP were excluded from the MSE analysis.2

Exploratory Endpoint

Clinical deterioration observations

Clinical deterioration events per 100 patient-years2,a

Bar graph showing reduction in clinical deterioration events: 60.4 per 100 patient-years for patients on placebo vs 12.6 for those on ULTOMIRIS

This graphic is adapted from Vu TH, Mantegazza R, Annane D, et al. Eur J Neurol, 2025, 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/.

aClinical 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

b1-year prestudy period, events reported by investigators. Patients may have been on other medications to treat generalized myasthenia gravis during this period.2

BL, baseline; CS, corticosteroids; IST, immunosuppressive therapy; LS, least squares; MG, myasthenia gravis; MGFA, Myasthenia Gravis Foundation of America; MG-QoL15r, myasthenia gravis Quality of Life 15-item scale revised; MMRM, mixed model for repeated measures; Neuro-QoL, Neurological Disorders Quality of Life; 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.

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