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dc.contributor.authorCro, S.
dc.contributor.authorCornelius, V. R.
dc.contributor.authorPink, A. E.
dc.contributor.authorWilson, R.
dc.contributor.authorPushpa-Rajah, A.
dc.contributor.authorPatel, P.
dc.contributor.authorAbdul-Wahab, A.
dc.contributor.authorAugust, S.
dc.contributor.authorAzad, J.
dc.contributor.authorBecher, G.
dc.contributor.authorChapman, A.
dc.contributor.authorDunnil, G.
dc.contributor.authorFerguson, A. D.
dc.contributor.authorFogo, A.
dc.contributor.authorGhaffar, S. A.
dc.contributor.authorIngram, J. R.
dc.contributor.authorKavakleiva, S.
dc.contributor.authorLadoyanni, E.
dc.contributor.authorLeman, J. A.
dc.contributor.authorMacbeth, A. E.
dc.contributor.authorMakrygeoegou, A.
dc.contributor.authorParslew, R.
dc.contributor.authorRyan, A. J.
dc.contributor.authorSharma, A.
dc.contributor.authorShipman, A. R.
dc.contributor.authorSinclair, C.
dc.contributor.authorWachsmuth, R.
dc.contributor.authorWoolf, R. T.
dc.contributor.authorWright, A.
dc.contributor.authorMcAteer, H.
dc.contributor.authorBarker, Jnwn
dc.contributor.authorBurden, A. D.
dc.contributor.authorGriffiths, C. E. M.
dc.contributor.authorReynolds, N. J.
dc.contributor.authorWarren, R. B.
dc.contributor.authorLachmann, H. J.
dc.contributor.authorCapon, F.
dc.contributor.authorSmith, C. H.
dc.identifier.citationBr J Dermatol. 2021 Aug 19. doi: 10.1111/bjd.20653.
dc.description.abstractBACKGROUND: 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.
dc.rightsThis article is protected by copyright. All rights reserved.
dc.titleAnakinra for palmoplantar pustulosis: results from a randomized, double-blind, multicentre, two staged, adaptive placebo controlled trial (APRICOT)
dc.typeJournal Article
dc.identifier.journalThe British journal of dermatology
dc.description.noteThe article is available via Open Access. Click on the 'Additional link' above to access the full-text.
dc.description.admin-notePublished version, accepted version (12 month embargo), submitted version

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