Ocrelizumab (Ocrevus)

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

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

Administration

  • xxxx

Dose Adjustment

  • Hepatic:
  • Renal:

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

References

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