A prospective observational cohort study comparing the treatment effectiveness and safety of ciclosporin, dupilumab and methotrexate in adult and paediatric patients with atopic dermatitis: results from the UK-Irish A-STAR register

Alexander, Helen, Malek, Rayka, Prieto-Merino, David, Gribaleva, Elizaveta, Baden, Manisha, Beattie, Paula, Brown, Sara, Burton, Tim, Cameron, Shona, Coker, Bola, Cork, Michael J., Hearn, Ross, Ingram, John R. ORCID: https://orcid.org/0000-0002-5257-1142, Irvine, Alan D., Johnston, Graham A., Lambert, Alice, Lunt, Mark, Man, Irene, Newell, Louise, Ogg, Graham, Patel, Prakash, Wan, Mandy, Warren, Richard B., Woolf, Richard, Yiu, Zenas Z. N., Reynolds, Nick, Ardern-Jones, Michael R, Flohr, Carsten, Ardern-Jones, Michael R, Beattie, Paula, Brown, Sara, Brown, Victoria, Cork, Michael J., Darné, Sharmela, Fadhil, May, Fahy, Caoimhe, Ferguson, Leila, Flohr, Carsten, Hearn, Ross, Johnston, Graham A., Ladoyanni, Effi, Layton, Alison, Leitch, Claire, Llewellyn, Joanne, Lunt, Mark, Man, Irene, Newell, Louise, Ogg, Graham, Popli, Urvi, Reynolds, Nick, Sergeant, Ann, Thompson, Ben, Topliffe, Joanne, Wahie, Shyamal, Wainman, Hannah, Warren, Richard B., Wernham, Aaron, Woolf, Richard and Yiu, Zenas Z. N. 2024. A prospective observational cohort study comparing the treatment effectiveness and safety of ciclosporin, dupilumab and methotrexate in adult and paediatric patients with atopic dermatitis: results from the UK-Irish A-STAR register. British Journal of Dermatology 191 (6) , pp. 988-999. 10.1093/bjd/ljae287

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Abstract

Background The main conventional systemic atopic dermatitis (AD) treatments are methotrexate (MTX) and ciclosporin (CyA). Dupilumab was the first novel systemic agent to enter routine clinical practice. There are no head-to-head randomised controlled trials or real-world studies comparing these agents directly. Network meta-analyses provide indirect comparative efficacy and safety data and have shown strong evidence for dupilumab and CyA. Objectives The aim of this study was to compare the real-world clinical effectiveness and safety of CyA, dupilumab and MTX in AD. Methods We compared the effectiveness and safety of these systemic agents in a prospective observational cohort study of adult and paediatric patients recruited into the UK-Irish Atopic eczema Systemic TherApy Register (A-STAR). Treatment effectiveness measures included Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), Peak Pruritus Numerical Rating Scale (PP-NRS), Dermatology Life Quality Index (DLQI) and children’s DLQI (cDLQI). Minimum duration of treatment was 28 days and follow-up was 12 months. Adjusted Cox-regression was used to compare the hazards of achieving EASI-50, EASI-75 and EASI-90 over time, and linear mixed-effects models were used to estimate changes in efficacy scores. Treatment safety was assessed by examining adverse events (AEs) at follow-up visits. Results 488 patients (n=311 adults and n=177 children/adolescents) on dupilumab (n=282), methotrexate (n=149), or CyA (n=57) were included. CyA and MTX were primarily used first line, while dupilumab was mainly a second line systemic as per UK National Institute of Clinical and Care Excellence (NICE) recommendations. EASI-50, EASI-75 and EASI-90 were achieved more rapidly in the dupilumab and CyA groups compared to MTX. After adjustment for previous severity, the reduction in EASI, POEM, PP-NRS and DLQI was greater for patients treated with dupilumab compared to MTX. In severe patients the reduction in EASI, POEM, and PP-NRS was even greater with CyA. The incidence of AEs was similar across groups (734, 654 and 594 per 10,000 person-month on CyA, dupilumab and MTX respectively). Conclusions This real-world comparison of CyA, dupilumab and MTX in AD suggests that dupilumab is consistently more effective than MTX and that CyA is most effective in very severe disease within one follow-up year.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Oxford University Press
ISSN:	0007-0963
Date of First Compliant Deposit:	8 August 2024
Date of Acceptance:	23 July 2024
Last Modified:	10 Dec 2024 15:45
URI:	https://orca.cardiff.ac.uk/id/eprint/171255

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