Nemolizumab in moderate to severe atopic dermatitis: An exploratory analysis of work productivity and activity impairment in a randomized phase II study

J Dermatol. 2019 Aug;46(8):662-671. doi: 10.1111/1346-8138.14934. Epub 2019 Jun 5.

Abstract

Atopic dermatitis negatively impacts work productivity. This study investigated the impact of nemolizumab on work productivity and activity impairment in adults with moderate to severe atopic dermatitis inadequately controlled by topical treatments in a two-part, phase II, randomized control trial. The Work Productivity and Activity Impairment - Atopic Dermatitis questionnaire was an exploratory end-point. Part A was a 12-week, placebo-controlled study in which patients received s.c. nemolizumab 0.1, 0.5 or 2.0 mg/kg every 4 weeks or 2.0 mg/kg every 8 weeks. Part B was a 52-week extension in which all patients received active treatment. A total of 138 patients had Work Productivity and Activity Impairment - Atopic Dermatitis data; 104 were employed at baseline. At week 12, patients receiving nemolizumab every 4 weeks showed greater mean (standard error) Work Productivity and Activity Impairment - Atopic Dermatitis improvement (score reduction) from baseline versus placebo: Percent Work Time Missed (0.1, 0.5 or 2.0 mg/kg vs placebo): -4.0% (3.9%), -1.7% (4.2%) and -1.6% (4.2%) versus 4.9% (4.5%); Percent Impairment While Working, -15.8% (6.0%), -24.1% (6.5%) and -34.3% (6.4%) versus -16.5% (7.1%); Percent Overall Work Impairment, -16.3% (6.0%), -23.1% (6.5%) and -34.5% (6.3%) versus -16.6% (7.1%); and Percent Activity Impairment, -13.4% (5.3%), -23.5% (5.3%) and -41.9% (5.5%) versus -10.9% (5.7%). Improvements were sustained through week 64. Nemolizumab-treated patients with moderate to severe atopic dermatitis reported improvements in Work Productivity and Activity Impairment through week 64.

Keywords: atopic dermatitis; clinical trial phase II; nemolizumab; pharmacotherapy; skin diseases.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Absenteeism
  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Dermatitis, Atopic / complications
  • Dermatitis, Atopic / diagnosis
  • Dermatitis, Atopic / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Efficiency / drug effects*
  • Female
  • Humans
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Placebos / administration & dosage
  • Presenteeism
  • Severity of Illness Index
  • Surveys and Questionnaires / statistics & numerical data
  • Treatment Outcome
  • Work / statistics & numerical data*
  • Young Adult

Substances

  • Antibodies, Monoclonal, Humanized
  • Placebos
  • nemolizumab