A small population, randomised, placebo-controlled trial to determine the efficacy of anakinra in the treatment of pustular psoriasis: study protocol for the APRICOT trial

Trials
Victoria CorneliusCatherine Smith

Abstract

Palmoplantar pustulosis is a rare but painful and debilitating disease. It consistently ranks the highest of all psoriasis phenotypic variants in terms of symptoms and functional impairment. Management of plaque-type psoriasis has been revolutionised in the last 10 years with the advent of biologic therapies, but treatment options for pustular psoriasis remain profoundly limited. On the basis of mechanistic findings which suggest a key pathogenic role for interleukin (IL)-1 in pustular psoriasis, we hypothesise that anakinra (IL-1 blockade) will be an efficacious treatment for pustular psoriasis. We will conduct a two-stage, adaptive, double-blind, randomised, placebo-controlled trial to test the hypothesis that anakinra, self-administered daily by subcutaneous injection over 8 weeks, will deliver therapeutic benefit in palmoplantar pustular psoriasis, a localised form of pustular psoriasis typically involving the palms and/or soles. Safety outcomes will be collected for 20 weeks. A total of 64 participants will be randomised to anakinra or placebo in a 1:1 ratio. At the end of stage 1, a decision to progress to stage 2 will be made. This decision will take place after 24 participants have been randomised and followed for 8 wee...Continue Reading

References

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Citations

Sep 17, 2020·JAMA Dermatology·Natashia Benzian-OlssonUNKNOWN ERASPEN consortium and the APRICOT and PLUM study team
Feb 6, 2020·Paediatric Drugs·Yi-Wei Huang, Tsen-Fang Tsai
Sep 5, 2020·Clinical, Cosmetic and Investigational Dermatology·Egídio FreitasTiago Torres
Dec 22, 2020·Therapeutic Advances in Musculoskeletal Disease·Katharina MeierKamran Ghoreschi

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