Background/Purpose: Corticosteroids are commonly utilized, along with other agents in clinical practice for pre-infusion prophylaxis prior to the administration of therapeutic biologic proteins. Two steroids, methylprednisolone and hydrocortisone, are commonly used.  Because of the differing characteristics of these two agents, a chart review evaluating outcomes was performed.

Methods: Nineteen sites completed a retrospective chart review of pegloticase treated gout patients who completed at least three (3) infusions since 1/1/2012. Pegloticase is typically administered at 8 mg every 2 weeks, the FDA approved dose. Data collected included demographics, gout history, contraindications to both infusion reaction prophylaxis and gout flare prophylaxis medications, pre and post treatment serum uric acid (sUA) level, and prior gout treatment. This analysis includes data from 92 patients. Data were analyzed using multiple logistic regression, with number of infusions as a response variable and age, sUA prior to the last infusion, type of infusion prophylaxis corticosteroid (hydrocortisone or methylprednisolone) as treatment outcome predictor variables.

Results: Patient characteristics are similar to the typical pegloticase treated population.

Use of methylprednisolone as compared to hydrocortisone as pre-infusion prophylaxis was a significant (p<.001) predictor of pegloticase therapy duration (number of infusions). Furthermore, the mean number of infusions when methylprednisolone was used (8.48) was significantly higher than when hydrocortisone was used (4.93) (p<.001). As previously published, serum uric acid (sUA) drawn immediately prior to infusion was also a significant predictor of continued therapy and remains a key determinant for sustained pegloticase infusions. There was no significant difference between sUA levels prior to initiation of pegloticase therapy for these two groups.

Conclusion: Data from this retrospective chart review indicates that methylprednisolone pre-infusion therapy may allow for longer pegloticase therapy duration as compared with hydrocortisone. However, this modality imposes a significantly higher glucocorticoid load that may suppress symptoms of an infusion reaction rather than inhibit pegloticase drug antibody formation. The long term use of methylprednisolone prophylaxis may result in glucocorticoid related adverse effects. Methylprednisolone use as compared to hydrocortisone for infusion prophylaxis needs further study to determine efficacy and long-term safety.