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@article{Cro:2022:10.1111/bjd.20653,
author = {Cro, S and Cornelius, VR and Pink, AE and Wilson, R and Pushpa-Rajah, A and Patel, P and Abdul-Wahab, A and August, S and Azad, J and Becher, G and Chapman, A and Dunnil, G and Ferguson, AD and Fogo, A and Ghaffar, SA and Ingram, JR and Kavakleiva, S and Ladoyanni, E and Leman, JA and Macbeth, AE and Makrygeoegou, A and Parslew, R and Ryan, AJ and Sharma, A and Shipman, AR and Sinclair, C and Wachsmuth, R and Woolf, RT and Wright, A and McAteer, H and Barker, JNWN and Burden, AD and Griffiths, CEM and Reynolds, NJ and Warren, RB and Lachmann, HJ and Capon, F and Smith, CH and APRICOT, Study Group},
doi = {10.1111/bjd.20653},
journal = {British Journal of Dermatology},
pages = {245--256},
title = {Anakinra for palmoplantar pustulosis: results from a randomized, double-blind, multicentre, two staged, adaptive placebo controlled trial (APRICOT).},
url = {http://dx.doi.org/10.1111/bjd.20653},
volume = {186},
year = {2022}
}

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TY  - JOUR
AB  - BACKGROUND: Palmoplantar pustulosis (PPP) is a rare, debilitating, chronic inflammatory skin disease affecting the hands and feet. Clinical, immunological and genetic findings suggest a pathogenic role for interleukin (IL)-1. OBJECTIVE: To determine whether anakinra (an IL-1 receptor antagonist) delivers therapeutic benefit for PPP. METHODS: A randomised (1:1), double-blind, two-staged, adaptive, UK multi-centre, placebo-controlled trial. Participants had a diagnosis of PPP (>6 months) requiring systemic therapy. Treatment was eight weeks of anakinra or placebo via daily self-administered subcutaneous injections. The primary outcome was the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at 8 weeks. RESULTS: A total of 374 patients were screened and 64 were enrolled (31 anakinra, 33 placebo) with mean baseline PPPASI 17.8 (SD=10.5); PPP investigator's global assessment severe (50%) or moderate (50%). The baseline adjusted mean difference in PPPASI favoured anakinra but did not demonstrate superiority in intention-to-treat analysis, -1.65, 95% CI [-4.77 to 1.47], p=0.300. Secondary objective measures including fresh pustule count (2.94, 95% CI [-26.44 to 32.33] favouring anakinra), total pustule count (-30.08, 95% CI [-83.20 to 23.05] favouring placebo), and patient-reported outcomes, similarly did not show superiority of anakinra. When modelling the impact of adherence, the PPPASI complier average causal effect (CACE) for an individual who receives ≥90% total treatment (48% anakinra group), was -3.80, 95% CI [-10.76 to 3.16], p=0.285. No serious adverse events occurred. CONCLUSIONS: No evidence for superiority of anakinra was found. IL-1 blockade is not a useful intervention for the treatment of PPP.
AU  - Cro,S
AU  - Cornelius,VR
AU  - Pink,AE
AU  - Wilson,R
AU  - Pushpa-Rajah,A
AU  - Patel,P
AU  - Abdul-Wahab,A
AU  - August,S
AU  - Azad,J
AU  - Becher,G
AU  - Chapman,A
AU  - Dunnil,G
AU  - Ferguson,AD
AU  - Fogo,A
AU  - Ghaffar,SA
AU  - Ingram,JR
AU  - Kavakleiva,S
AU  - Ladoyanni,E
AU  - Leman,JA
AU  - Macbeth,AE
AU  - Makrygeoegou,A
AU  - Parslew,R
AU  - Ryan,AJ
AU  - Sharma,A
AU  - Shipman,AR
AU  - Sinclair,C
AU  - Wachsmuth,R
AU  - Woolf,RT
AU  - Wright,A
AU  - McAteer,H
AU  - Barker,JNWN
AU  - Burden,AD
AU  - Griffiths,CEM
AU  - Reynolds,NJ
AU  - Warren,RB
AU  - Lachmann,HJ
AU  - Capon,F
AU  - Smith,CH
AU  - APRICOT,Study Group
DO  - 10.1111/bjd.20653
EP  - 256
PY  - 2022///
SN  - 0007-0963
SP  - 245
TI  - Anakinra for palmoplantar pustulosis: results from a randomized, double-blind, multicentre, two staged, adaptive placebo controlled trial (APRICOT).
T2  - British Journal of Dermatology
UR  - http://dx.doi.org/10.1111/bjd.20653
UR  - https://www.ncbi.nlm.nih.gov/pubmed/34411292
UR  - https://onlinelibrary.wiley.com/doi/10.1111/bjd.20653
UR  - http://hdl.handle.net/10044/1/91222
VL  - 186
ER  -

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