A Prospective, Observational Study to Assess the Long-Term Safety of Abrocitinib Treatment in Adult Patients with Moderate-to-Severe Atopic Dermatitis

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  CIBINQO
• Study drug International non-proprietary name (INN) or common name:
  ABROCITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH08) abrocitinib

  abrocitinib
• Medical condition to be studied:
  Dermatitis atopic

Population studied

• Short description of the study population:
  The study will use real-world data (RWD) collected in the context of routine clinical care from the CorEvitas AD Registry, which is an established, prospective, multicenter, observational registry for adult patients in the US and Canada.
• Age groups:
  Adult and elderly population (≥18 years)

Study design details

• Study design:
  This is a prospective, observational cohort study of adult patients (≥ 18 years) receiving abrocitinib or comparator biologic or non-biologic (non-JAKi) chronic systemic treatments for atopic dermatitis (AD).
• Main study objective:
  The main objective is to estimate the incidence rates (IR) of safety events of interest including malignancies excluding NMSC, NMSC, MACE, serious infections, opportunistic infections, HZ, retinal detachment, thrombosis (including deep venous thrombosis, pulmonary embolism, and arterial thrombosis), and hepatotoxicity (including; DILI) in adults with AD who are exposed to abrocitinib during the course of routine clinical care. To contextualize the results, the study will also include patients receiving comparator biologic and non-biologic (non-JAKi) chronic systemic treatments for AD.
• Setting:
  The CorEvitas AD registry currently enrolls a broad eligible population for participation in the registry. Though the registry is open to patients initiating or having recently (within 12 months) initiated a biologic or systemic therapy for AD, approximately 90% of patients enrolling into the registry are being treated with a biologic, with approximately 10% currently treated with a non-biologic systemic treatment.
• Comparators:
  The comparator group will include exposures to any biologic or non-biologic (non-JAKi) chronic systemic therapy used for the treatment of AD, including new therapies as they become approved. ;
• Outcomes:
  Total malignancies excluding nonmelanoma skin cancer (NMSC), but including lymphoma, lung cancer, and other; malignancies, NMSC, MACE, serious infections, opportunistic infections, herpes zoster (HZ), retinal detachment, thrombosis (including deep venous thrombosis, pulmonary embolism and arterial thrombosis), and hepatotoxicity including drug induced liver injury (DILI).
• Data analysis plan:
  All analyses will characterize exposure time into an abrocitinib group and a comparator group. For each grouping, the baseline will be characterized by treatment exposure group with respect to demographic, disease activity and disease severity, validated patient-reported outcome measures (e.g., DLQI), and history of safety events of special interest using descriptive statistics. Mean, median, minimum, and maximum values, interquartile range (IQR), and standard deviation will be provided for continuous variables when performing descriptive analysis of continuous data. Numbers and percentages will be provided for dichotomous and polychotomous variables when performing summary analysis of categorical data.; Except the sensitivity analysis using propensity-score matching method, all other analyses will employ inverse probability of treatment weighting (IPTW) as the primary analytic approach to address confounding by indication (channeling bias, notably including line of therapy) and preserve sample size. For all primary analyses, only the first event of each individual event type will be evaluated; the incident event will end the risk period for that; event type.; Additionally, for events where there is adequate power to compare the risk between abrocitinib and comparators, multivariable Cox proportional hazards models will be fit to compare risk of the event between abrocitinib and the comparator groups.; Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP), which will be dated, filed, and maintained by the sponsor. The SAP may modify the plans outlined in the protocol; any major modifications of definitions for the main safety events of interest or their analyses would be reflected in a protocol amendment.