Table 1

Specific objectives (participants, interventions, comparators, outcomes and design).

ParticipantsPatients (children and adults) with moderate-to-severe atopic dermatitis
InterventionsSystemic immunomodulatory agents, including:
  • Ciclosporin.

  • Methotrexate.

  • Azathioprine.

  • Mycophenolate.

  • Corticosteroids.

  • Dupilumab.

  • Nemolizumab.

  • Lebrikizumab.

  • Ustekinumab.

  • Fezakinumab.

  • Baricitinib.

  • Apremilast.

  • Interferon.

  • Intravenous immunoglobulin.

  • Others, including new agents whose first trials are published between publication of this protocol and our final literature search.

ComparatorsAny, including placebo.
Outcomes Primary outcomes – efficacy
  1. Change in investigator-reported clinical signs (eg, EASI and o-SCORAD).

  2. Change in patient-reported symptoms (eg, POEM).

Primary outcomes - safety
  1. Withdrawal from systemic treatment due to adverse events.

  2. Occurrence of serious adverse events.

Secondary outcomes
  1. Change in health-related quality of life (eg, DLQI).

  2. Change in itch severity.

DesignRandomised controlled trials.
  • DLQI, Dermatology Life Quality Index; EASI, Eczema Area Severity Index; o-SCORAD, objective SCORAD; POEM, Patient Oriented Eczema Measure.