Indications

Multiple Sclerosis (see Multiple Sclerosis, [[Multiple Sclerosis]])

Clinical Efficacy

• ORATORIO Trial of Ocrelizumab in Primary Progressive Multiple Sclerosis (NEJM, 2017) [MEDLINE]
  • In Primary Progressive Multiple Sclerosis, Ocrelizumab was Associated with Lower Rates of Clinical and MRI Progression, as Compared to Placebo
• OPERA I Trial
  • XXXXX
• OPERA II Trial
  • XXXXX

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Pharmacology

• Humanized (90%-95% Human) Monoclonal Anti-CD20 Antibody (see Anti-CD20 Therapy, [[Anti-CD20 Therapy]]): present on B-cells -> results in B-cell depletion

Metabolism

• xxxx

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Administration

• xxxx

Dose Adjustment

• Hepatic:
• Renal:

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Adverse Effects

General Comments

• Infusion Reaction
  • Epidemiology
    • In Multiple Sclerosis Patients Who Have Received Methylprednisolone or Equivalent Corticosteroid as Preventative Measure, Infusion Reaction Occurs in Approximately 34-40% of Patients*
      • Highest Incidence Occurs with the First Infusion
      • No Fatal Infusion Reactions Have Occurred, But 0.3% of Treated Patients Experienced Serious Reactions (Some Requiring Hospitalization)
  • Prevention
    • Pre-infusion Corticosteroids (see Corticosteroids, [[Corticosteroids]])
    • Pre-Infusion Acetaminophen (Tylenol) (see Acetaminophen, [[Acetaminophen]])
  • Treatment
    • Stop/Slow Rate of Infusion
    • Symptomatic Treatment

Cardiovascular Adverse Effects

• Hypotension (see Hypotension, [[Hypotension]])
  • Epidemiology: may occur as part of infusion reaction
• Tachycardia (see Sinus Tachycardia, [[Sinus Tachycardia]])
  • Epidemiology: may occur as part of infusion reaction

Dermatologic Adverse Effects

• Erythema/Flushing (see Flushing, [[Flushing]])
  • Epidemiology: may occur as part of infusion reaction
• Pruritus (see Pruritus, [[Pruritus]])
  • Epidemiology: may occur as part of infusion reaction
• Rash (see xxxx, [[xxxx]])
  • Epidemiology: may occur as part of infusion reaction
• Skin Infection
• Urticaria (see Urticaria, [[Urticaria]])
  • Epidemiology: may occur as part of infusion reaction

Gastrointestinal Adverse Effects

• Nausea (see Nausea, [[Nausea]])

Neurologic Adverse Effects

• Dizziness (see Dizziness, [[Dizziness]])
  • Epidemiology: may occur as part of infusion reaction
• Fatigue (see Fatigue, [[Fatigue]])
  • Epidemiology: may occur as part of infusion reaction
• Headache (see Headache, [[Headache]])
  • Epidemiology: may occur as part of infusion reaction

Otolaryngologic Adverse Effects

• Laryngeal/Pharyngeal Edema (see xxxx, [[xxxx]])
  • Epidemiology: may occur as part of infusion reaction
• Oropharyngeal Pain (see Pharyngitis, [[Pharyngitis]])
  • Epidemiology: may occur as part of infusion reaction

Pulmonary Adverse Effects

• Bronchospasm (see Obstructive Lung Disease, [[Obstructive Lung Disease]])
  • Epidemiology: may occur as part of infusion reaction
• Dyspnea (see Dyspnea, [[Dyspnea]])
  • Epidemiology: may occur as part of infusion reaction
• Upper Respiratory Tract Infection
• Lower Respiratory Tract Infection

Other Adverse Effects

• Fever (see Fever, [[Fever]])
  • Epidemiology: may occur as part of infusion reaction

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References

• ORATORIO Trial. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017;376(3):209. Epub 2016 Dec 21 [MEDLINE]