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Praluent Autoimmune Disease Considerations: What Clinicians Need to Know

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At a glance

  • Contraindication / history of a serious hypersensitivity reaction to alirocumab or an excipient [1]
  • Only Warning and Precaution / hypersensitivity reactions, including hypersensitivity vasculitis and angioedema [1]
  • Boxed warning / none [1]
  • Autoimmune disease in the contraindications section / not listed [1]
  • Hypersensitivity reactions, pooled adult trials / 8.6% vs 7.8% placebo; pruritus 1.1% vs 0.4% [1]
  • Serious allergic reactions in controlled trials / hypersensitivity, nummular eczema, hypersensitivity vasculitis [1]
  • CYP and transporter effects / statin concentrations unchanged; CYP3A4, CYP2C9, P-gp and OATP not affected [1]

What does the label say about immune-related reactions?

Alirocumab is a human monoclonal antibody that binds PCSK9 and lowers LDL cholesterol by increasing the number of LDL receptors available to clear it [1]. The label carries no boxed warning. Its single Warning and Precaution is hypersensitivity reactions, including hypersensitivity vasculitis, angioedema, and reactions requiring hospitalization. The label says that if signs or symptoms of a serious hypersensitivity reaction occur, Praluent should be discontinued, treated according to the standard of care, and the patient monitored until signs and symptoms resolve [1].

Autoimmune disease does not appear in the contraindications section. The one contraindication is a history of a serious hypersensitivity reaction to alirocumab or any excipient, with hypersensitivity vasculitis, angioedema, and reactions requiring hospitalization given as examples of what has occurred [1].

Which reactions showed up in the trials?

In nine placebo-controlled adult trials (2,476 patients on Praluent 75 or 150 mg every 2 weeks for a median of 65 weeks; 1,276 on placebo), hypersensitivity reactions were reported in 8.6% versus 7.8%, with pruritus the most common at 1.1% versus 0.4% [1]. Allergic reactions were among the most common reasons for stopping treatment, 0.6% versus 0.2%, alongside elevated liver enzymes (0.3% versus under 0.1%) [1]. Serious allergic reactions reported in controlled trials included hypersensitivity, nummular eczema, and hypersensitivity vasculitis [1]. Angioedema and influenza-like illness appear in the postmarketing reports [1]. Injection-site reactions were reported in 7% versus 5% [1].

What does the label say about drug interactions?

Alirocumab is a protein expected to degrade to small peptides and individual amino acids, and no specific metabolism studies were conducted [1]. When it was given with atorvastatin or rosuvastatin, statin concentrations were unchanged, indicating that CYP3A4, CYP2C9, P-gp, and OATP were not affected [1].

Frequently asked questions

Does Praluent have any autoimmune contraindications?
No autoimmune condition appears in the contraindications section. The single contraindication is a history of a serious hypersensitivity reaction to alirocumab or any excipient, including prior hypersensitivity vasculitis, angioedema, or a reaction requiring hospitalization [1].
Has alirocumab been linked to vasculitis or other serious allergic reactions?
The label reports hypersensitivity vasculitis among serious allergic reactions seen in controlled trials and angioedema in postmarketing reports [1]. Both fall under the label's hypersensitivity warning, which says to discontinue treatment, treat according to the standard of care, and monitor until signs and symptoms resolve [1].
Does Praluent affect CYP enzymes or statin levels?
No. In clinical studies with atorvastatin or rosuvastatin, statin concentrations did not change, indicating that CYP3A4, CYP2C9, P-gp, and OATP were not affected [1]. Alirocumab is expected to break down into small peptides and amino acids, and specific metabolism studies were not conducted [1].
What is the Praluent starting dose?
For adults with hypercholesterolemia, including HeFH, the label lists a starting dose of 75 mg every 2 weeks or 300 mg every 4 weeks subcutaneously, adjusted to 150 mg every 2 weeks if the LDL-C response is inadequate. LDL-C can be measured as early as 4 weeks [1].

References

  1. U.S. National Library of Medicine, DailyMed. Praluent alirocumab injection (Regeneron) prescribing information. Praluent alirocumab injection (Regeneron) label
Evidence overview for alirocumab: Praluent Autoimmune Disease Considerations: What Clinicians Need to Know