TRACE
Research type
Research Study
Full title
Tralokinumab ReAl world Clinical usE: An observational cohort study of atopic dermatitis patients prescribed tralokinumab (TRACE)
IRAS ID
308587
Contact name
Michael Cork
Contact email
Sponsor organisation
LEO PHARMA A/S
Clinicaltrials.gov Identifier
EUPAS44659 ,
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Research Summary:
This study is a non-interventional study with primary data collection and it is designed as a prospective, observational, multi-centric, multinational cohort study of patients with Atopic dermatitis, eligible for treatment with tralokinumab according to the national approved label (new users).
The study is planned to be conducted in 15 countries in Europe, and North America.
Included sites and investigators should be representative for health care professionals prescribing biologics to AD patients. Sites can be hospital (university, private, public) dermatology departments, and private dermatology clinics.
Atopic dermatitis is a long-term skin inflammation characterized by irritations such as itchy, dry and red skin. It can represent a burden in patient’s everyday life.
Tralokinumab induced significant clinical improvement in moderate to severe Atopic dermatitis in a small number of clinical trials. However, to-date there is a lack of long-term data and evidence for the clinical use and response of tralokinumab in a real world setting. The rationale of this study is to assess changes in clinical signs and symptoms of Atopic dermatitis in patients treated with tralokinumab in a real‐world setting over a one year period. Secondary objectives include: observe safety in patients treated with Tralokinumab, patient characterization, explore baseline predictors of clinical response and describe the real world use of Tralokinumab.
This observational study is research that aims to collect data over time on how a certain treatment is used and its effects, without any change to patients normal care. The decision to prescribe tralokinumab for the patient must fall within current practice, be independent and not influenced by potential subsequent participation in the study. Patients must be informed about the study and asked for consent to use their data, and patients willing to participate be enrolled. Any patient can withdraw his/her consent at any time. Informed consent, demographics, medical history, Atopic dermatitis treatment during the study period and assessment of Atopic dermatitis severity will be collected and in addition, patient-reported outcomes (PROs) are collected if considered normal clinical practice.Lay summary of study results:
TRACE is an international, non-interventional, prospective, single-cohort study of patients with atopic dermatitis prescribed tralokinumab according to national approved label and followed for up to 12 months of treatment. The design was chosen to assess changes in clinical signs, symptoms, and quality of life associated with tralokinumab use in daily clinical practice.
The enrolment of patients started after the market launch in each country. Relevant data was collected according to local clinical practice at every visit within 56 weeks (at 3, 6, 9, and 12 months) after first dose of administration of tralokinumab (i.e., the baseline visit).
The results in TRACE both support and strengthen the existing evidence on the effectiveness of tralokinumab for treatment of atopic dermatitis in a real-world setting.
For an observation period of 12 months in adult patients with atopic dermatitis, where tralokinumab was prescribed according to national approved label, the observed effectiveness was:
• Throughout the 12-month observation period, continuous improvements were seen in the proportion of patients who obtained an investigator-assessed composite response (IGA (investigator’s global assessment) 0/1, EASI75(at least 75%reduction in EASI (eczema activity and severity index) score /EASI (eczema activity and severity index)≤7, or SCORAD (scoring atopic dermatitis) ≤9.9).
• None of the variable’s ‘weight’, ‘prior use of systemic atopic dermatitis treatment’, or ‘country’ were considered to have an impact on obtaining a composite response.
• For each of the investigator-related assessments IGA (investigator’s global assessment), EASI (eczema activity and severity index), and SCORAD (scoring atopic dermatitis), continuous improvements in proportion of patients who obtained a response were seen throughout the 12-month observation period.
• Mean BSA (body surface area) score improved continuously throughout the 12-month observation period.
• Improvements in PROs (patient-reported outcomes) of atopic dermatitis disease severity and impact on quality of life (PP-NRS (peak-pruritus numeric rating scale), DLQI (dermatology quality of life index), and Sleep-numeric rating scale were seen throughout the 12-month observation period, supporting the results of the investigator-assessed outcomes of atopic dermatitis disease severity.
• Improvements in all WPAI-GH (work productivity and activity impairment questionnaire-general health) scores, ADCT (atopic dermatitis control tool) score, and RECAP (recap of atopic eczema) score were seen throughout the 12-month observation period.
• The proportion of patients who in relation to their atopic dermatitis received urgent medical care, outpatient treatment/examination, hospitalized, or visited their GP or another specialist decreased over the 12-month observation period. Further, the number of visits to an outpatient clinic, GP, or dermatologist decreased.
• There were only minor changes in use of TCSs (topical corticosteroid), TCIs (topical calcineurin inhibitor), and other non-TCS (topical corticosteroid) topical treatments as co-medication for atopic dermatitis during the 12-month observation period.
• Most patients continued the 2-week treatment regimen throughout the 12-month observation period.
• Overall, no pronounced differences were seen between the subgroups analysed.
Safety results
Tralokinumab, prescribed per national guidelines in real-world use, was well tolerated with no new safety concerns seen over 12 months of treatment based on observed adverse events.
• 232 (28.1%) of the 825 patients reported at least 1 AE (adverse event) and for 132 (16.0%) of the patients, at least 1 of the AEs (adverse event) were assessed as possibly related to tralokinumab.
• Most AEs (adverse event) were non-serious and of mild or moderate severity.
• Despite some differences between countries, the overall pattern in AE (adverse event) reporting was consistent across countries.
Results from this 12-month observational study both support and strengthen the existing evidence on effectiveness of tralokinumab for treatment of atopic dermatitis in a real-world setting. Further, no new safety signals identified during the 12-month observation period.
The results support the favourable benefit-risk profile of tralokinumab.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
22/YH/0240
Date of REC Opinion
1 Nov 2022
REC opinion
Further Information Favourable Opinion