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@article{Cro:2022:10.3310/mxpk2427,
author = {Cro, S and Cornelius, V and Capon, F and Barker, J and Burden, D and Griffiths, C and Lachmann, HJ and McAteer, H and Patel, P and Pink, A and Reynolds, N and Warren, R and Smith, C},
doi = {10.3310/mxpk2427},
journal = {Efficacy and Mechanism Evaluation},
pages = {1--106},
title = {The interleukin 1 receptor antagonist anakinra to reduce disease severity of palmoplantar pustulosis in adults: APRICOT RCT and PLUM mechanistic study},
url = {http://dx.doi.org/10.3310/mxpk2427},
volume = {9},
year = {2022}
}

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TY  - JOUR
AB  - BackgroundPalmoplantar pustulosis is a rare, debilitating, chronic skin disease involving the hands and feet, and there are limited treatment options. Mechanistic findings suggest that interleukin 1 may be a pathogenic driver.ObjectiveTo determine whether or not anakinra [Sobi (Swedish Orphan Biovitrum AB), Stockholm, Sweden], an interleukin 1 receptor antagonist, delivers therapeutic benefit in palmoplantar pustulosis.DesignA Phase IV, randomised, double-blind, placebo-controlled study with two stages and an adaptive element (24 participants in stage 1, 64 participants in total) with an open-label extension.SettingSixteen hospitals across England, Scotland and Wales.ParticipantsAdults (aged ≥ 18 years) with a diagnosis of palmoplantar pustulosis and a disease duration of > 6 months and of sufficient impact and severity to require systemic therapy.InterventionsParticipants were randomised (1 : 1) to daily self-administered subcutaneous injection of either anakinra or a placebo for 8 weeks.Main outcome measuresThe primary outcome was the Palmoplantar Pustulosis Area and Severity Index score measured at 0, 1, 4, 8 and 12 weeks, with the primary end point at 8 weeks adjusted for baseline. Secondary outcomes included other investigator-assessed efficacy measures of disease severity, safety measures and participant-reported measures of efficacy and impact.ResultsA total of 64 participants (mean baseline Palmoplantar Pustulosis Area and Severity Index score of 17.8, standard deviation 10.5) received anakinra (n = 31) or the placebo (n = 33). In the primary intention-to-treat analysis, which estimated the effect of the treatment policy, the mean treatment group difference at 8 weeks after adjustment for baseline Palmoplantar Pustulosis Area and Severity Index score was –1.65 (95% confidence interval –4.77 to 1.47; p = 0.300), in favour of anakinra relative to placebo, but was not statis
AU  - Cro,S
AU  - Cornelius,V
AU  - Capon,F
AU  - Barker,J
AU  - Burden,D
AU  - Griffiths,C
AU  - Lachmann,HJ
AU  - McAteer,H
AU  - Patel,P
AU  - Pink,A
AU  - Reynolds,N
AU  - Warren,R
AU  - Smith,C
DO  - 10.3310/mxpk2427
EP  - 106
PY  - 2022///
SN  - 2050-4365
SP  - 1
TI  - The interleukin 1 receptor antagonist anakinra to reduce disease severity of palmoplantar pustulosis in adults: APRICOT RCT and PLUM mechanistic study
T2  - Efficacy and Mechanism Evaluation
UR  - http://dx.doi.org/10.3310/mxpk2427
UR  - https://www.journalslibrary.nihr.ac.uk/eme/MXPK2427#/abstract
UR  - http://hdl.handle.net/10044/1/97407
VL  - 9
ER  -

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