Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate

IRs, including anaphylaxis, were assessed after each infusion for a period of 24 weeks. IRs were defined as any infusion-related adverse event (AE) or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and up to 2 hours post-infusion. Additional AEs occurring outside of the 2-hour window following infusion could also be categorized as an IR at the Principal Investigator's discretion.

Time frame: Day 1 to Week 24

Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of pegloticase.

IRs were defined as any infusion-related AE or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and for 2 hours post-infusion. Other AEs that occurred outside of the 2 hour window following the infusion may have also been categorized as an IR at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual sUA discontinuation criteria was defined as two consecutive pre-infusion sUAs \> 6 mg/dL after Day 1.

Time frame: Day 1 to Week 24

Population: SAS: All participants who received at least 1 dose of pegloticase.

Responders were defined as participants who achieved and maintained sUA levels below 6 mg/dL for at least 80% of the time during month 6. Responders who met sUA discontinuation criteria (2 consecutive sUA \> 6 mg/dL), regardless of treatment status were considered non-responders.

Time frame: Up to 6 months

Population: mITT Analysis Set: All participants who received at least 1 dose of pegloticase.

Infusion reactions were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1. Time to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. All participants were censored at the date of their last infusion.

Time frame: Day 1 to Week 24

Population: SAS: All participants who received at least 1 dose of pegloticase.

IRs were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1. Time to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. Only participants who experienced an event were included in this analysis.

Time frame: Day 1 to Week 24

Population: All participants who received at least 1 dose of pegloticase and experienced an IR leading to discontinuation of treatment, anaphylaxis or met sUA discontinuation criteria.