Related Experiment Video

Updated: May 23, 2026

The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis
11:39

The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis

Published on: July 11, 2013

Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients

Ignacio Garcia-Doval1, Gregorio Carretero, Francisco Vanaclocha

  • 1Department of Dermatology, Complexo Hospitalario de Pontevedra, SERGAS (Servizo Galego de Saude), Pontevedra, Spain. ignacio.garcia.doval@sergas.es

Archives of Dermatology
|April 18, 2012
PubMed
Abstract

Insights

Nearly 30% of psoriasis patients receiving systemic therapy are ineligible for clinical trials and face a higher risk of serious adverse events (SAEs). Biologics increase SAE risk in all patients, but particularly in those ineligible for trials.

Area of Science:

  • Dermatology
  • Clinical Pharmacology
  • Public Health

Background:

  • Randomized controlled trials (RCTs) often exclude patients with specific comorbidities or demographic factors.
  • Systemic therapies for psoriasis, including biologics and classic drugs, are crucial but their safety in underrepresented patient groups requires investigation.

Purpose of the Study:

  • To evaluate the use and safety of systemic psoriasis therapies in patients not typically included in randomized controlled trials (RCTs).
  • To assess the risk of serious adverse events (SAEs) in these underrepresented patient populations.

Main Methods:

  • A registry inception cohort study was conducted across 13 Spanish dermatology departments.
  • Included 1042 patients (2179 person-years) receiving biologics or classic systemic therapies.
  • Defined ineligibility for RCTs by factors like advanced age, non-plaque psoriasis types, specific infections, cancer history, or chronic organ disease.

Main Results:

  • Approximately 29.8% of patients receiving systemic psoriasis therapy were ineligible for RCTs.
  • These ineligible patients exhibited a 2.7-fold increased risk of serious adverse events (SAEs).
  • Biologic therapy was associated with an increased risk of SAEs (IRR 2.3), irrespective of RCT eligibility, but added to a higher baseline risk in ineligible patients.

Conclusions:

  • A significant proportion of patients receiving systemic psoriasis treatment are ineligible for RCTs and face a heightened risk of SAEs.
  • Close monitoring is recommended for patients ineligible for RCTs undergoing systemic therapy.
  • The risk-benefit profile of biologic therapies may differ between RCT-eligible and ineligible patients due to baseline risk variations.

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