Provided herein are methods and compositions, such as kits, related to compositions comprising synthetic nanocarriers comprising an immunosuppressant and compositions comprising an uricase and a composition comprising an anti-inflammatory therapeutic. Also provided herein are methods and compositions for the treatment of subjects in need of administration or treatment with the uricase.

A uricase gel preparation for external use comprises the following components by weight: greater than 0 and less than or equal to 1.0% of uricase, 0.05-20% of an aqueous gel matrix, 0.15-20% of a protein protectant, 2-25% of a humectant, 0.01-0.20% of a chelating agent, 0.001-3.0% of a transdermal enhancer, 0.005-0.5% of a preservative and the balance of water for injection. The pH of the preparation is adjusted to 5-10 by a pH adjuster. The method for preparing the gel preparation comprises: preparing a standby substance from some of the components; respectively formulating each of the remaining components with a water for injection; adding the preservative into the standby substance and adjusting the pH; adding the protein protectant, uricase and water for injection; stirring uniformly same and then subpackaging same to obtain the gel preparation.

Provided herein are methods and compositions and kits related to uricase compositions and/or compositions comprising synthetic nanocarriers comprising an immunosuppressant. Also provided herein are methods and compositions and kits for the treatment of subjects, including subjects with hyperuricemia, gout or a condition associated with gout, and for preventing gout flare.

The present invention relates to a novel peptide or a partial sequence thereof for enhancing expression efficiency of a target protein, and a fusion protein comprising the same. The novel peptide according to the present invention can enhance expression efficiency of a target protein, and furthermore, the peptide can also be applied to a solubility-enhancing fusion protein in order to enhance solubility of the target protein, so that solubility as well as expression efficiency of the target protein is enhanced, which allows such a peptide to be usefully used for production of a recombinant target protein.

Genetically modified proteins with uricolytic activity are described. Proteins comprising truncated urate oxidases and methods for producing them, including PEGylated proteins comprising truncated urate oxidase are described.

Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response during intravenous PEGylated uricase therapy in gout patients is provided. Routine SUA monitoring can be used to identify patients receiving PEGylated uricase who may no longer benefit from treatment and who are at greater risk for infusion reactions.

The disclosure provides methods of treating gout in patients comprising administering a PEGylated uricase in a shortened infusion period less than 120 minutes and a shortened infusion volume of less than 250 mL. Also provided are methods of treating gout in patients comprising co-administering a PEGylated uricase and methotrexate (MTX). Also provided are methods of reducing immunogenicity of a PEGylated uricase and prolonging the urate lowering effect comprising co-administration of the PEGylated uricase and MTX.

Disclosed are methods for treating gouty arthropathy in a subject that is allergic to a uricase. In some aspect, disclosed herein are methods for desensitizing a subject allergic to a uricase.

Genetically modified proteins with uricolytic activity are described. Proteins comprising truncated urate oxidases and methods for producing them, including PEGylated proteins comprising truncated urate oxidase are described.

Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response during intravenous PEGylated uricase therapy in gout patients is provided. Routine SUA monitoring can be used to identify patients receiving PEGylated uricase who may no longer benefit from treatment and who are at greater risk for infusion reactions.