Focus areas

Background

Atopic Dermatitis (AD) is the most common chronic inflammatory skin disease in the Netherlands with more than 400.000 patients. For patients with difficult to treat AD, treatment options are limited. Although the Dutch AD Guideline recommends oral immunosuppressive drugs in difficult to treat AD, both label and off-label, daily practice studies show high rates of discontinuation of treatment due to side effects and/or ineffectiveness. Dupixent® (dupilumab) as the first biological developed for AD, has been commercially available in the Netherlands since January 2018. Although a number of large phase 3 trials have shown very positive results and limited side effects, effectiveness and safety data from daily practice are necessary to study long-term effectiveness and safety in a less selected population compared to clinical trials. A well designed high quality prospective registry can provide these essential data.

Objectives
Primary objectives

The aim of this registry is to prospectively collect daily practice data regarding effectiveness and safety of new treatment options in patients with AD in a multicenter setting.

Primary objectives

  1. To assess the effectiveness and safety of new treatments in adult and pediatric patients with AD using physician-measured clinical eczema scores as well as patient-reported outcome measures.
  2. To study drug survival and identify factors that affect drug survival.
  3. To register objective and subjective side effects and to identify potential risk factors.

Secondary objectives

  1. To characterize patient populations treated with new AD treatments in daily practice.
  2. To collect data from daily practice regarding side effects (incidence, severity, risk factors, treatment options, etc.).
  3. To study the usefulness of laboratory monitoring during treatment in daily practice, with emphasis on subpopulations (e.g. elderly patients, patients with pre-existing liver and/or renal disease).
  4. To study the long-term safety risks including malignancies, pregnancy/paternity-related conditions, infections, autoimmune diseases.
  5. To prospectively collect data from daily practice regarding the effect of new treatment options for AD on comorbidities.

Study population
Adult patients with difficult to treat AD, who are treated with new systemic treatment in daily practice according to the Dutch AD guideline (after treatment failure of at least 1 oral immunosuppressive drug or a contra-indication for oral immunosuppressive drugs).