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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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In some cases, there...
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Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Brodalumab: Six-Year US Pharmacovigilance Report.

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Brodalumab (interleukin-17 receptor A antagonist) shows a consistent long-term safety profile in plaque psoriasis patients over six years. No completed suicides were reported, and fungal infection rates remained low.

Keywords:
Adverse eventsDrug reactionPsoriasisReal-worldSafety

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Area of Science:

  • Immunodermatology
  • Pharmacovigilance
  • Drug Safety

Background:

  • Brodalumab is an interleukin-17 receptor A antagonist for moderate-to-severe plaque psoriasis unresponsive to other systemic therapies.
  • The drug carries a boxed warning for suicidal ideation and behavior in the US, necessitating long-term safety assessment.
  • This study evaluates six years of real-world clinical practice data to assess brodalumab's long-term safety.

Purpose of the Study:

  • To summarize pharmacovigilance data and assess the long-term safety of brodalumab in plaque psoriasis patients.
  • To analyze adverse event reporting rates, including major adverse cardiovascular events, serious infections, malignancies, and suicidal behavior.

Main Methods:

  • Calculated crude adverse event (AE) reporting rates per 100 patients for common and special interest AEs.
  • Estimated brodalumab exposure from prescription dispensing data over a six-year period (August 2017 - August 2023).
  • Defined AEs using Medical Dictionary for Regulatory Activities (MedDRA) v26.0 Preferred Terms and standardized queries.

Main Results:

  • Data from 5138 US patients (6900 patient-years) revealed 13 major adverse cardiovascular events (0.25/100 patients) and 2.20 serious infections per 100 patients.
  • One new case of Candida infection and one serious fungal infection were reported since the 5-year assessment.
  • No new suicide attempts were reported in the sixth year, and no completed suicides occurred over the six-year period; 4 of 57 malignancies were possibly related to brodalumab.

Conclusions:

  • Six-year pharmacovigilance data align with brodalumab's established clinical trial safety profile.
  • The safety profile remains consistent, with no completed suicides and a low rate of fungal infections observed.
  • Real-world data support the long-term safety of brodalumab for plaque psoriasis management.