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Patient Safety and Risk Management
PS-026 Relative safety of biological drugs in the maintenance phase in adult patients with moderate to severe plaque psoriasis
  1. M Galván-Banqueri1,
  2. A Castillo-Muñoz1,
  3. R Ubago-Pérez1,
  4. L Abdel-Kader Martín1,
  5. C Beltrán-Calvo2,
  6. T Molina-López3
  1. 1Andalusian Agency for Health Technology Assessment, Health Technology Assessment, Seville, Spain
  2. 2Andalusian Agency for Health Technology Assessment, Chief of Health Technology Assessment, Seville, Spain
  3. 3Andalusian Agency for Health Technology Assessment, Director of Health Technology Assessment, Seville, Spain

Abstract

Background Infliximab, adalimumab, etanercept and ustekinumab are indicated to treat moderate-severe plaque psoriasis in Europe.

Purpose To assess the relative safety of biological drugs in the maintenance phase in adult patients with moderate-severe plaque psoriasis.

Materials and methods A systematic literature review was conducted focused on the long term safety.

The selection criteria of the studies for this review were: health technology agencies’ reports, meta-analyses and systematic reviews in patients with moderate-severe plaque psoriasis treated with biologicals at the doses approved by the EMA. Searches were conducted in MEDLINE, Embase, the Cochrane Library and CRD databases until March 2013. The end points evaluated were mortality, adverse events (AEs), serious AEs and withdrawals due to AEs.

Two authors independently selected the studies, assessed the quality and performed the data extraction.

Results There was no direct evidence or adjusted indirect comparisons that compared the relative safety of the four biological drugs.

The evidence was obtained from five systematic reviews.

Biological agents appear to have a similar safety profile, with a low incidence of serious AEs in eligible psoriasis patients. Biological treatment was well tolerated in the long term and showed neither dose- nor time-dependent toxicity.

The AE rates per patient-year of exposure/follow-up differ significantly between the four drugs. In addition, for drugs launched ahead of time (such as etanercept), safety controls were less stringent.

Based on unadjusted indirect comparisons:

  • Etanercept has the highest mortality, infectious AEs and non-melanoma skin cancer (non-metastatic cutaneous squamous cell or basal cell carcinoma) rates per 100 patient-years of exposure, followed by ustekinumab and adalimumab, which have similar rates.

  • Infliximab presents the highest rate of serious infectious AEs, despite being the biological agent with the shortest follow-up phase.

Conclusions The available evidence is insufficient to suggest differences in safety between the four biological drugs.

No conflict of interest.

https://doi.org/10.1136/ejhpharm-2013-000436.377

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