Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR).

2022-08-17

James, Fiona L

Goh, Michelle S Y

Mouhtouris, Effie

Vogrin, Sara

Chua, Kyra Y L

Holmes, Natasha E

Awad, Andrew

Copaescu, Ana

De Luca, Joseph F

Zubrinich, Celia

Gin, Douglas

Cleland, Heather

Douglas, Abby

Kern, Johannes S

Katelaris, Constance H

Thien, Francis

Barnes, Sara

Yun, James

Tong, Winnie

Smith, William B

Carr, Andrew

Anderson, Tara

Legg, Amy

Bourke, Jack

Mackay, Laura K

Aung, Ar Kar

Phillips, Elizabeth J

Trubiano, Jason

Adverse events

CLINICAL PHARMACOLOGY

Dermatological epidemiology

EPIDEMIOLOGY

IMMUNOLOGY

PREVENTIVE MEDICINE

Journal Article

http://orcid.org/0000-0003-0469-5666

http://orcid.org/0000-0002-9183-5032

http://orcid.org/0000-0001-6541-5512

http://orcid.org/0000-0002-5111-6367

http://orcid.org/0000-0003-3491-2633

http://orcid.org/0000-0001-8826-7137

http://orcid.org/0000-0001-8501-4054

http://orcid.org/0000-0003-4604-1062

10.1136/bmjopen-2021-055906

Severe cutaneous adverse reactions (SCAR) are a group of T cell-mediated hypersensitivities associated with significant morbidity, mortality and hospital costs. Clinical phenotypes include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP). In this Australasian, multicentre, prospective registry, we plan to examine the clinical presentation, drug causality, genomic predictors, potential diagnostic approaches, treatments and long-term outcomes of SCAR in Australia and New Zealand. Adult and adolescent patients with SCAR including SJS, TEN, DRESS, AGEP and another T cell-mediated hypersensitivity, generalised bullous fixed drug eruption, will be prospectively recruited. A waiver of consent has been granted for some sites to retrospectively include cases which result in early mortality. DNA will be collected for all prospective cases. Blood, blister fluid and skin biopsy sampling is optional and subject to patient consent and site capacity. To develop culprit drug identification and prevention, genomic testing will be performed to confirm human leukocyte antigen (HLA) type and ex vivo testing will be performed via interferon-γ release enzyme linked immunospot assay using collected peripheral blood mononuclear cells. The long-term outcomes of SCAR will be investigated with a 12-month quality of life survey and examination of prescribing and mortality data. This study was reviewed and approved by the Austin Health Human Research Ethics Committee (HREC/50791/Austin-19). Results will be published in peer-reviewed journals and presented at relevant conferences. Australian New Zealand Clinical Trials Registry (ACTRN12619000241134).

link

BMJ Open 2022; 12(8): e055906

BMJ Open