REduCing Immunogenicity to PegloticasE (RECIPE) Study

Summary

Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life.

Timeline

Start

2018-06-14

Primary completion

2020-04-27

Completion

2021-03-31

Outcome

Met primary endpoint

paper 19 (86%) of 22 participants in the MMF arm compared to 4 (40%) of 10 in the placebo arm (P = 0.01). PMID 33750034 ↗

registry analysis (superiority test); Pegloticase + MMF vs Pegloticase + Placebo; p <0.01; Fisher Exact NCT03303989 ↗

Publications

• Khanna PP, Khanna D, Cutter G, Foster J, Melnick J, Jaafar S, Biggers S, Rahman AKMF, Kuo HC, Feese M, Kivitz A, King C, Shergy W, Kent J, Peloso PM, Danila MI, Saag KG. Reducing Immunogenicity of Pegloticase With Concomitant Use of Mycophenolate Mofetil in Patients With Refractory Gout: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Aug;73(8):1523-1532. doi: 10.1002/art.41731. Epub 2021 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Mofetil	Small molecule	1000 mg	—
Comparator	Pegloticase	Protein / enzyme biologic	8 mg	Intravenous

Indications