ULTOMIRIS®: Strive for zero relapses as a treatment goal moving forward1,2
ULTOMIRIS® is indicated in the treatment of adult patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive.3 Please consult the Summary of Product Characteristics prior to prescribing.
healthcare professional
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ULTOMIRIS® is contraindicated in patients who are not currently vaccinated against Neisseria meningitidis and in patients with unresolved Neisseria meningitidis infection at treatment initiation unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.3
CHAMPION-NMOSD is a phase 3, externally placebo-controlled, open-label, multicenter study to evaluate the efficacy and safety of ravulizumab in adult patients with anti-aquaporin-4 antibody-positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD).3,4
Efficacy results should be interpreted with reasonable care as the study design was open-label with an external placebo control arm from the PREVENT study.4,5
* Range (11.0–117.7 weeks).4
† vs external placebo, P < 0.0001; HR=0.014; (95% CI: 0.000, 1.103). Patients were allowed to have concomitant IST treatment. The safety and efficacy of ULTOMIRIS® were studied in CHAMPION-NMOSD (NCT04201262), also known as ALXN1210-NMO-307 or CHAMPION-NMO-307, a global, external placebo-controlled, open-label, multicentre trial of 58 adults with anti-AQP4 Ab+ NMOSD. The placebo group of the PREVENT trial was used as external control (n=47).4
‡ ULTOMIRIS® must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal, neuromuscular or neuroinflammatory disorders. Minimum infusion time for ULTOMIRIS® 100 mg/mL maintenance doses ranges from 30 minutes to 75 minutes, depending on body weight.3
† vs external placebo, P < 0.0001; HR=0.014; (95% CI: 0.000, 1.103). Patients were allowed to have concomitant IST treatment. The safety and efficacy of ULTOMIRIS® were studied in CHAMPION-NMOSD (NCT04201262), also known as ALXN1210-NMO-307 or CHAMPION-NMO-307, a global, external placebo-controlled, open-label, multicentre trial of 58 adults with anti-AQP4 Ab+ NMOSD. The placebo group of the PREVENT trial was used as external control (n=47).4
‡ ULTOMIRIS® must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal, neuromuscular or neuroinflammatory disorders. Minimum infusion time for ULTOMIRIS® 100 mg/mL maintenance doses ranges from 30 minutes to 75 minutes, depending on body weight.3
ULTOMIRIS® is the first and only treatment that offers immediate, complete, and sustained C5 inhibition in adult patients with anti-AQP4 antibody-positive NMOSD; preventing inflammation and astrocyte death, which are primary drivers of disability in NMOSD.3,4
NMOSD is a chronic, complement-mediated autoimmune disease of the CNS, characterised by frequent and unpredictable attacks that lead to irreversible damage1,2,6,7
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* Clinical outcomes and prognostic characteristics of 106 AQP4 Ab+ patients from the UK and Japan. Data were collected largely retrospectively through review of case records.8
† Ex vivo analysis of how human neutrophils affect astrocytes in the presence of anti-AQP4 Ab-positive serum derived from NMOSD patients.10
NMOSD attacks result in patients experiencing rapid accumulation of irreversible disability. There is an urgent need to prevent these attacks to avoid cumulative disability.6,8,11
Every relapse event can put your patient at risk of blindness, pain, paralysis or premature death6,9
As severe disability can result from even a single relapse, remaining relapse-free is the primary treatment goal for NMOSD1,2,6,9
As severe disability can result from even a single relapse, remaining relapse-free is the primary treatment goal for NMOSD1,2,6,9
* From Mayo Clinic records (2005–2011), 163 patients with NMO were identified; 110 (67%) were seropositive and 53 (33%) were scored seronegative. Data presented are specifically for seropositive patients.12
Relapse triggered by complement activation is a reality in NMOSD. Address its
potentially devastating impact.3,7,9,13
The efficacy and safety of ULTOMIRIS® was studied in CHAMPION-NMOSD4
AQP4-IgG+, aquaporin-4 immunoglobulin G positive; CNS, central nervous system; NMOSD, neuromyelitis optica spectrum disorder.
Adverse Event Reporting
Please report any adverse reactions via your national reporting system. Adverse events should also be reported to Alexion pharmaceuticals by the following link: https://contactazmedical.astrazeneca.com