Adverse reactions (ARs) reported in ≥5% of adult patients with anti-AQP4 antibody-positive NMOSD treated with ULTOMIRIS®1

Body System AR ULTOMIRIS (n=58)
n (%)
Blood and Lymphatic System Disorders
Lymphadenopathy 3 (5)
Gastrointestinal Disorders
Constipation 4 (7)
Vomiting 4 (7)
Diarrhea 3 (5)
Gastroesophageal reflux disease 3 (5)
General Disorders/Administration Site Reactions
Pyrexia 5 (9)
Chills 3 (5)
Fatigue 3 (5)
Malaise 3 (5)
Non-cardiac chest pain 3 (5)
Vaccination site pain 3 (5)
Injury, Poisoning, and Procedural Complications
Infusion-related reaction 4 (7)
Body System AR (cont'd) ULTOMIRIS (n=58)
n (%)
Infections and Infestations
COVID-19 14 (24)
Urinary tract infection 6 (10)
Cystitis 5 (9)
Upper respiratory tract infection 5 (9)
Nasopharyngitis 3 (5)
Sinusitis 3 (5)
Musculoskeletal and Connective Tissue Disorders
Back pain 7 (12)
Arthralgia 6 (10)
Myalgia 3 (5)
Nervous System Disorders
Headache 14 (24)
Dizziness 4 (7)
Migraine 3 (5)
Respiratory, Thoracic, and Mediastinal Disorders
Cough 3 (5)
  • Discontinuation due to ARs occurred with 1 (1.7%) patient who experienced 3 separate infections2
  • The most frequent ARs occurring in ≥10% of patients taking ULTOMIRIS were COVID-19 (24%), headache (24%), back pain (12%), arthralgia (10%), and urinary tract infection (10%)2
  • Serious ARs were reported in 8 (13.8%) patients1
  • The most frequent serious ARs were infections and infestations, reported in 5 (8.6%) patients3
  • Of the 14 patients who contracted COVID-19 during the global pandemic, none of these infections were serious or resulted in discontinuation of ULTOMIRIS treatment2,3

Long-term extension safety results (interim analysis)4*

Safety profile remained consistent through the LTE

ARs reported in ≥10% of adult patients with anti-AQP4 antibody-positive NMOSD treated with ULTOMIRIS during the primary treatment period and LTE4

Body System AR ULTOMIRIS (n=58) n (%)
Gastrointestinal Disorders
Diarrhea 6 (10)
General Disorders/Administration Site Reactions
Pyrexia 6 (10)
Infections and Infestations
COVID-19 26 (45)
Urinary tract infection 9 (16)
Upper respiratory tract infection 8 (14)
Nasopharyngitis 6 (10)
Musculoskeletal and Connective Tissue Disorders
Back pain 8 (14)
Arthralgia 7 (12)
Nervous System Disorders
Headache 19 (33)

*Median follow-up (range) of 138.4 weeks (min 11.0, max 183.1) for ravulizumab (n=58) and 36.0 weeks (min 1.9, max 183.1) for placebo (n=47). Patients may have transitioned to the extension period as early as 52 weeks. This data is from an interim analysis with a cutoff of June 2023, however the study is still ongoing.4

AQP4, aquaporin-4; COVID-19, coronavirus disease 2019; LTE, long-term extension; NMOSD, neuromyelitis optica spectrum disorder.