SOLIRIS SAFETY IN NMOSD

Safety from the 3+ year PREVENT study and PREVENT open-label extension (OLE) study

PREVENT

PREVENT OLE

Adverse reactions reported in 5% or more of SOLIRIS® (eculizumab)-treated patients in the 3+ year PREVENT study and at a greater frequency than in placebo-treated patients1,2

SOLIRIS (N=96) Placebo (N=47)
N (%) N (%)
Events/patients 1295/88 617/45
Blood and lymphatic system disorders
Leukopenia 5 (5) 1 (2)
Lymphopenia 5 (5) 0 (0)
Eye disorders
Cataract 6 (6) 2 (4)
Gastrointestinal disorders
Diarrhea 15 (16) 7 (15)
Constipation 9 (9) 3 (6)
General disorders and administration site conditions
Asthenia 5 (5) 1 (2)
Infections and infestations
Upper respiratory tract infection 28 (29) 6 (13)
Nasopharyngitis 20 (21) 9 (19)
Influenza 11 (11) 2 (4)
Pharyngitis 10 (10) 3 (6)
Bronchitis 9 (9) 3 (6)
Conjunctivitis 9 (9) 4 (9)
Cystitis 8 (8) 1 (2)
Hordeolum 7 (7) 0 (0)
Sinusitis 6 (6) 0 (0)
Cellulitis 5 (5) 1 (2)
Injury, poisoning, and procedural complications
Contusion 10 (10) 2 (4)
Metabolism and nutrition disorders
Decreased appetite 5 (5) 1 (2)
Musculoskeletal and connective tissue disorders
Back pain 14 (15) 6 (13)
Arthralgia 11 (11) 5 (11)
Musculoskeletal pain 6 (6) 0 (0)
Muscle spasms 5 (5) 2 (4)
Nervous system disorders
Dizziness 14 (15) 6 (13)
Paraesthesia 8 (8) 3 (6)
Respiratory, thoracic, and mediastinal disorders
Oropharyngeal pain 7 (7) 2 (4)
Skin and subcutaneous tissue disorders
Alopecia 5 (5) 2 (4)

SOLIRIS is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS)1

Learn more about the risk of meningococcal infections.

PREVENT OLE study3

PREVENT OLE primary objective: long-term safety analysis

Overall, 111 (93.3%) patients in the study reported a total of 1778 treatment-emergent adverse events (TEAEs) during the study for a TEAE rate of 624.7 events per 100 PY. 

TEAEs by Preferred Term and Treatment Group for Events Occurring in ≥5% of Patients Overall

Preferred term Total (N=119)
PY=284.6
Events n Rate per 100 PY Patients n (%)
Events and patients with events 1778 624.7 111 (93.3)
Nasopharyngitis 67 23.5 29 (24.4)
Upper respiratory tract infection 51 17.9 28 (23.5)
Headache 174 61.1 27 (22.7)
Urinary tract infection 65 22.8 25 (21.0)
Arthralgia 38 13.4 23 (19.3)
Influenza 25 8.8 19 (16.0)
Pyrexia 27 9.5 18 (15.1)
Back pain 33 11.6 16 (13.4)
Diarrhea 28 9.8 14 (11.8)
Pain in extremity 36 12.6 13 (10.9)
Cough 19 6.7 12 (10.1)
Fatigue 20 7.0 11 (9.2)
Constipation 12 4.2 10 (8.4)
Contusion 16 5.6 10 (8.4)
Muscle spasms 13 4.6 10 (8.4)
Nausea 21 7.4 10 (8.4)
Anemia 10 3.5 9 (7.6)
Cystitis 12 4.2 9 (7.6)
Oropharyngeal pain 13 4.6 9 (7.6)
Dizziness 10 3.5 8 (6.7)
Oral herpes 21 7.4 8 (6.7)
Bronchitis 12 4.2 7 (5.9)
Hypoesthesia 9 3.2 7 (5.9)
Iron deficiency anemia 7 2.5 7 (5.9)
Asthenia 6 2.1 6 (5.0)
Dyspepsia 14 4.9 6 (5.0)
Insomnia 8 2.8 6 (5.0)
Paraesthesia 7 2.5 6 (5.0)
Rash 8 2.8 6 (5.0)
Rhinorrhea 7 2.5 6 (5.0)
Thermal burn 11 3.9 6 (5.0)
Toothache 8 2.8 6 (5.0)

Treatment-emergent serious adverse events (TESAEs)

A total of 90 TESAEs were reported by 40 (33.6%) patients during the study, for a rate of 31.6 events per 100 PY. Nineteen of these events were considered related to the study drug. TESAEs (excluding NMOSD) that were reported in more than 1 patient include acute cholecystitis, urinary tract infection, arthralgia, and optic neuritis (2 [1.7%] patients each). TESAEs were most frequently reported in the following system organ classes: infections and infestations (19 [16.0%] patients); nervous system (11 [9.2%] patients); musculoskeletal and connective tissue disorders (8 [6.7%] patients); injury, poisoning, and procedural complications (4 [3.4%] patients); and respiratory, thoracic, and mediastinal disorder (4 [3.4%] patients). Urinary tract infection (5 [4.2%] patients) was the most commonly reported TESAE other than NMOSD (5 [4.2%] patients). There were no TESAEs that were reported in ≥5% of patients overall.

Serious infections (18 [15.1%] patients) and infusion reactions (8 [6.7%] patients) were the most commonly reported TEAEs of special interest. Of the serious infections, urinary tract infection was the most common (5 [4.2%] patients).

A total of 3 (2.5%) patients experienced 6 TEAEs that led to withdrawal from the study drug during the OLE period.

TEAEs were AEs with a start date on or after the first dose of study drug in PREVENT OLE. Percentages were based on the total number of patients in the extension safety set in the particular treatment group. If a patient had multiple events for a particular PT, they were counted only once for that PT.

Abbreviations: AE, adverse event; PT, preferred term; PY, patient-years.

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IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING

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WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection).
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

Contraindications
  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection
Warnings and Precautions
Serious Meningococcal Infections
Risk and Prevention

The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). 

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.

Infusion-Related Reactions

Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. 

Adverse Reactions

The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

INDICATION
Neuromyelitis Optica Spectrum Disorder (NMOSD)

Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Please see full Prescribing Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection).
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

Contraindications
  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection
Warnings and Precautions
Serious Meningococcal Infections
Risk and Prevention

The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). 

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.

Infusion-Related Reactions

Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. 

Adverse Reactions

The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

INDICATION
Neuromyelitis Optica Spectrum Disorder (NMOSD)

Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Please see full Prescribing Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

References
1. SOLIRIS. Prescribing information. Alexion Pharmaceuticals, Inc. 2. Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(7):614-625. doi:10.1056/NEJMoa1900866 3. Data on file. Alexion Pharmaceuticals, Inc.

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