A study of growth, development and maturation in adolescents with atopic dermatitis who receive upadacitinib

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  RINVOQ
• Study drug International non-proprietary name (INN) or common name:
  UPADACITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA44) upadacitinib

  upadacitinib
• Medical condition to be studied:
  Dermatitis atopic

Population studied

• Age groups:
  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  700

Study design details

• Main study objective:
  To evaluate the growth, development and maturation in North American (US and Canada) [NA]-residing adolescents with moderate to severe Atopic Dermatitis who receive upadacitinib versus comparator medications. If feasible, a cohort of European residing adolescents with moderate to severe AD will also be evaluated.
• Outcomes:
  (1) compare changes from baseline in height and weight standard deviation score, (2) compare somatic maturity timing measured by age at peak height velocity, (3) compare changes from baseline in pubertal progression as measured by Tanner stage, and (4) compare the incidence rates of bone fractures in adolescents with moderate to severe AD treated with upadacitinib and comparator medications. The secondary objectives of the study are to describe changes from baseline in standing height, height percentiles, height velocity, height velocity SDS, weight, weight percentiles, body mass index (BMI), BMI percentiles, and BMI SDS, as well as the frequency of delayed puberty in adolescents with moderate to severe AD treated with upadacitinib and comparator medications.
• Data analysis plan:
  Primary Analysis: For each exposure cohort for the primary analyses, patient characteristics at baseline, including demographics, clinical and disease characteristics, treatment history, and patient reported outcomes will be described. Descriptive summary statistics will be provided for each study outcome. Changes for growth-related measures from baseline to end of follow-up will be described overall for all adolescents and by exposure cohort, including changes in height SDS and weight SDS. Age at peak height velocity (PHV), incidence of bone fractures during the follow-up period will be described by exposure cohort. Propensity score methods will be used to account for differences between exposure cohorts at baseline. Changes in height SDS, changes in weight SDS, age at PHV, age at Tanner stage progression, and incidence of bone fractures will be compared between the two propensity score trimmed exposure cohorts from North America. Refer to protocol abstract for secondary analysis.