Steroid use ULTOMIRIS® is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive.1 Please consult the Summary of Product Characteristics prior to prescribing.
Patients with gMG may face:3,5

Metabolic conditions

(weight gain, hyperglycaemia, diabetes)

Osteoporosis


Neuropsychiatric issues


Ophthalmologic conditions


Cardiovascular issues

(hypertension and arrhythmias) especially if pre-existing

Gastrointestinal issues


Electrolyte imbalances


Increased risk of infection


Myopathy


Consider exploring options that may allow you to reduce or eliminate corticosteroids3,6

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healthcare professional
Alexion has built a heritage of C5 inhibition in gMG treatment from studying SOLIRIS® (eculizumab) and ULTOMIRIS®.1,6–14
View SOLIRIS® steroid use data here
View the CHAMPION-MG and CHAMPION-MG OLE study designs here
CHAMPION-MG was a Phase 3, randomised, double-blind, placebo-controlled trial with an OLE. Patients were randomised to receive either ULTOMIRIS® (n = 86) or placebo (n = 89) for 26 weeks and allowed to enter the OLE period for up to 4 years.1,8,13

Outcome: Mean MG-ADL total score change from baseline to Week 26 was -3.1 (95% CI: -3.8, -2.3) in the ULTOMIRIS® group and -1.4 (95% CI: -2.1, -0.7) in the placebo group (P < 0.001).1,8,13 In the study, the average baseline total score for people receiving ULTOMIRIS® was 9.1; for people receiving placebo, it was 8.9.1,8,13

CHAMPION-MG OLE was the long-term extension trial following the 26th week of CHAMPION-MG. 161 participants received open-label ULTOMIRIS® following Week 26 and were observed through Week 60.8

LIMITATION: Results and clinical outcomes should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.8,13

Observation: In a prespecified interim analysis, 28% of patients reduced and 6.2% of patients stopped corticosteroid use after 34 weeks of the OLE period (45 and 10 patients, respectively).8
  • At baseline, approximately 90% of patients were taking an immunosuppressive therapy (IST) across both treatments13
  • At the time of ULTOMIRIS® initiation, in the ULTOMIRIS® arm, approximately 65% of patients were receiving corticosteroids (prednisone)13
  • 5.6% (9/161) of patients increased their corticosteroid use and 2.5% (4/161) of patients initiated corticosteroid use8
  • Percentages are based on all patients in the OLE, not just those on steroids8

Corticosteroid use will continue to be observed throughout the ongoing CHAMPION-MG OLE.8

CHAMPION-MG STUDY LIMITATION: Results and clinical outcomes should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.8,13

ULTOMIRIS® is the first and only long-acting C5 inhibitor that demonstrates the potential for steroid reduction1,8
compared with RCP baseline (95% CI: -4.8, -3.1)*8

* For patients who had received ULTOMIRIS® during the RCP and subsequently entered the OLE (N = 78), the mean MG-ADL total score at RCP baseline was 9.2.8
ULTOMIRIS® provides predictable, once-every-8-week dosing, starting 2 weeks after an initial loading dose; averaging around 6-7 maintenance infusions per year.1


At Week 60, compared with RCP baseline, improvements of ≥ 3 points on the MG-ADL scale were experienced by 76.4% (n = 42) of patients.8

CHAMPION-MG OLE STUDY LIMITATION: Results should be interpreted with caution since the study was designed to evaluate safety and lacked a control group.8

* In a prespecified interim ULTOMIRIS® treatment analysis (N = 161), 28% of patients reduced and 6.2% of patients stopped corticosteroid use after 34 weeks of the open-label extension (OLE) period (45 and 10 patients, respectively).8

† For patients treated with ULTOMIRIS® during the RCP who subsequently entered the OLE (N = 78), from RCP baseline to Week 60 the LS mean (95% CI) change in MG-ADL total score was -4.0 (-4.8, -3.1). The mean MG-ADL total score for this cohort at RCP baseline was 9.2.8

ULTOMIRIS® is the first and only long-acting, targeted C5 inhibitor to report on corticosteroid use. Some patients treated with ULTOMIRIS® may be able to reduce their regular corticosteroid dosage1,8,15,16
Learn more

To reduce this risk of infection, all patients must be vaccinated against meningococcal infections at least two weeks prior to initiating ULTOMIRIS® unless the risk of delaying ULTOMIRIS® therapy outweighs the risk of developing a meningococcal infection. Patients who initiate ULTOMIRIS® treatment less than 2 weeks after receiving a meningococcal vaccine, must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccines against serogroups A, C, Y, W135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups. Patients must be vaccinated or revaccinated according to current national guidelines for vaccination use. If the patient is being switched from SOLIRIS® treatment, physicians should verify that meningococcal vaccination is current according to national guidelines for vaccination use.1

Please consult the Summary of Product Characteristics prior to prescribing.
The most common adverse reactions with ravulizumab (intravenous formulation) are headache (28.2%), upper respiratory tract infection (19.9%), nasopharyngitis (19.5%), diarrhoea (16.9%), pyrexia (16.4%), nausea (13.7%), arthralgia (13.2%), fatigue (13.1%), back pain (12.6%), abdominal pain (11.8%), and dizziness (10.1%). The most serious adverse reactions are meningococcal infection (0.7%) including meningococcal sepsis, encephalitis meningococcal, meningococcal infection and disseminated gonococcal infection (0.1%).1
AChR, anti-acetylcholine receptor; CI, confidence interval; gMG, generalised myasthenia gravis; IST, immunosuppressive therapy; LS, least squares; MG-ADL, Myasthenia Gravis Activities of Daily Living; OLE, open-label extension; RCP, randomised-controlled period.
Adverse Event Reporting
Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion Pharmaceuticals by the following link: https://contactazmedical.astrazeneca.com/
ULTOMIRIS® Summary of Product Characteristics available at https://www.ema.europa.eu/en/documents/product-information/ultomiris-epar-product-information_en.pdf Last accessed: August 2024. Gilhus NE, et al. Myasthenia gravis. Nat Rev Dis Primers. 2019;5(1):30. Johnson S, et al. Adverse side effects associated with corticosteroid therapy: a study in 39 patients with generalized myasthenia gravis. Med Sci Monit. 2021;27:e933296. Sanders DB, et al. International consensus guidance for management of myasthenia gravis: executive summary. Neurology. 2016;87(4):419–425. Basoff D, et al. Comorbidities in patients with myasthenia gravis in the USA: a retrospective claims database analysis. Poster presented at: American Academy of Neurology Annual Meeting; April 22–27, 2023; Boston; MA. P1.5-003. Nowak RJ, et al. Concomitant immunosuppressive therapy use in eculizumab-treated adults with generalized myasthenia gravis during the REGAIN open-label extension study. Front Neurol. 2020;11:556104. Habib AA, et al; ELEVATE Study Group. Ravulizumab for the treatment of generalized myasthenia gravis: timing of response. Poster presented at: American Association of Neuromuscular & Electrodiagnostic Medicine Annual Myasthenia Gravis Foundation of America Scientific Session; September 21, 2022; Nashville, TN. Meisel A, et al. Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. J Neurol. 2023;270(8):3862–3875. Muppidi S, et al. Long-term safety and efficacy of eculizumab in generalized myasthenia gravis. Muscle Nerve. 2019;14–24. Howard JF, et al. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Lancet Neurol. 2017;16(12):976–986 (main article and supplementary appendix). Safety and efficacy of eculizumab in refractory generalized myasthenia gravis (REGAIN study). ClinicalTrials.gov identifier: NCT01997229. Updated July 16, 2019. Last accessed: August 2024. https://www.clinicaltrials.gov/study/NCT01997229 Vu T, et al. Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis. J Neurol. 2023;270:3129–3137. Vu T, et al. Terminal complement inhibitor ravulizumab in generalized myasthenia gravis. NEJM Evid. 2022;1(5):1–22. Pulley M, et al. Change in concomitant therapies for generalized myasthenia gravis in patients receiving eculizumab: a retrospective analysis of registry data. Poster presented at: American Academy of Neurology Annual Meeting; April 22–27, 2023; Boston, MA. P1.5-002. Kulasekararaj AG, et al. Ravulizumab (ALXN1210) vs eculizumab in C4-inhibitor-experienced adult patients with PNH: the 302 study. Blood. 2019;133(6):540–549. Lee JW, et al. Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naïve to complement inhibitors: the 301 study. Blood. 2019;133(6):530–539.