Adalimumab for psoriasis: safety profile confirmed across 18 long-term trials

  • Leonardi C & al.
  • Br J Dermatol
  • 31 Aug 2018

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • Long-term analysis of 18 clinical trials reveals similar safety of adalimumab (Humira) compared with earlier analyses in patients with moderate to severe chronic plaque psoriasis.

Why this matters

  • This study lends further support to the long-term safety of adalimumab and includes 5 new trials since a 2009 safety analysis.

Key results

  • There were 16,536 total adverse events (AEs), equivalent to 304.6 events per 100 patient-years (E/100 PYs).
    • 3798 AEs (70.0 E/100 PYs) were related to adalimumab as assessed by an investigator.
    • 269 AEs (5.0 E/100 PYs) led to discontinuation.
  • The most common AEs were nasopharyngitis (23.7 E/100 PYs), upper respiratory infection (12.9 E/100 PYs), and headache (7.9 E/100 PYs).
  • Serious AEs occurred at a rate of 8.4 E/100 PYs, while serious infections occurred at a rate of 1.8 E/100 PYs.
  • The incidence of nonmelanoma skin cancer was elevated in adalimumab patients (standardized incidence ratio, 1.55; 95% CI, 1.10-2.13).

Study design

  • 3723 patients with moderate to severe plaque psoriasis from 18 clinical trials who received adalimumab were analyzed for treatment-emergent AEs from first dose to 70 days after last dose or study cutoff date.
  • Funding: AbbVie Inc.

Limitations

  • Lack of long-term comparator group.

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