Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.

Official title

A Prospective, Multi-center Observational Study Characterizing Clinical Outcomes of Patients Receiving Abrocitinib for Moderate-to-severe Atopic Dermatitis Who Had an Inadequate Response (or Intolerance) to ≤2 Previous Biologic Therapies Approved for Moderate-to-severe Atopic Dermatitis

Overview

This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or intolerance) to ≤2 previous biologic therapies approved for M2S AD in the United States. The aim of this study is to measure the effectiveness of abrocitinib in a real-world setting in patients with moderate-to-severe atopic dermatitis, with inadequate response or intolerance to ≤2 biologic therapies.

Interventions

• Drug Abrocitinib
  Study Drug for Observational Data Collection.

Primary outcome measures

• Percentage of patients achieving EASI-75 improvement from baseline at Week 16 after index date [Time frame: Baseline, week 16]
• Percentage of patients achieving ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) collected daily all through the study from baseline at Week 2 by e-diary assessment [Time frame: Baseline, week 2]

Secondary outcome measures (12)

• Percentage of patients achieving EASI-75, 90 and 100 from baseline at Week 4 and 16 after index date [Time frame: Baseline, week 4, week 16]
• Percentage of patients achieving v-IGA response of Clear (0) or Almost Clear (1) and ≥ 2 points improvement from baseline at Week 4 and 16 after index date [Time frame: Baseline, week 4, week 16]
• Change from baseline in total percentage of BSA at week 4 and 16 [Time frame: Baseline, week 4, week 16]
• Percentage of patients achieving Peak Pruritus Numerical Rating Scale (PP-NRS) of 0 or 1 collected daily all through the study at Wk 4, 12 and 16 [Time frame: Baseline, week 4, 12 and 16]
• Percentage of patients achieving PP-NRS-4 at week 2, 4, 12 and 16 from baseline. [Time frame: Baseline, week 2, 4, 12 and 16]
• Absolute change from baseline in PP-NRS score at week 2 [Time frame: Baseline, week2]
• Proportion of patients overall "Very Satisfied" and "Satisfied" with abrocitinib at Wk 4, 12 and 16 with TSQM-9 [Time frame: Baseline, week 4, 12 and 16]
• Percentage of patients that report symptoms to be "minimal" or "absent" on the patient global impression of severity at week 4, 12 and 16 [Time frame: Baseline week 4, 12 and 16]
• Change from baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Wk 4, 12 and 16 [Time frame: Baseline, week 4, 12 and 16]
• Percentage of Participants with an ADCT Total Score Reduction ≥ 5 from baseline at week 4, 12 and 16 [Time frame: Baseline, week 4, 12 and 16]
• Percentage of Participants Achieving Improvement (reduction) in DLQI/CDLQI of ≥ 4 points vs baseline at week 4, 12 and 16 [Time frame: Baseline week 4, 12 and 16]
• Observational change in pigment alteration from baseline at week 4 and 16 by visual assessment of available photography [Time frame: Baseline, week 4, and 16]

Eligibility criteria

This NI study will enroll 150 patients from approximately 15 sites across the US. The study population eligible for enrollment includes adult and adolescent patients aged ≥12 years diagnosed with moderate to severe AD who receive at least one dose of abrocitinib and satisfy the inclusion and exclusion criteria. Patients who had inadequate response or intolerance to previous ≤2 biologic therapies will be included in this study as there is a lack of effectiveness data for abrocitinib in these patients. As this will be an observational study, there will be no sampling and all patients that meet the inclusion and exclusion criteria will be recruited consequently. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Regarding the inclusion and exclusion criteria, in the real-world setting recruitment may be slower than expected, thus depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study.

9.2.1. Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

• Participants who have chronic AD that has been present for ≥1 year before screening.
• Male and female patients aged >12 years at baseline.
• Patients with diagnosis of moderate-to-severe atopic dermatitis confirmed by a certified dermatologist, who are prescribed abrocitinib for use in accordance with the product label (USPI) and independently of the decision to enroll the patient in this study
• Patients who have inadequate responses or are intolerant to ≤2 previous biologic therapy approved for M2S AD. (Patients shall have had an inadequate response and/or intolerance to at least one, but no more than 2 biologic therapies approved for moderate-to-severe AD)
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the study, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
• Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.

9.2.2. Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

• Patients, that currently have active forms of other inflammatory skin diseases, other than AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 1 that would interfere with evaluation of atopic dermatitis or response to treatment.
• Patients previously treated with abrocitinib or other oral/systemic JAK inhibitors
• Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
• Patient eligibility should be reviewed, documented, and confirmed by an appropriately qualified member of the investigator's study team before patients are enrolled in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-crossover

Study locations

United States · 1 center

• Allergy and Asthma Medical Group and Research Center — San Diego

Identifiers

NCT: NCT06899204 · B7451125 · JADE-ADVANCED

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗