Improved joint and patient-reported health assessments with pegloticase plus methotrexate co-therapy in patients with uncontrolled gout: 12-month exploratory outcomes of the MIRROR open-label trial

Table 2 Summary of gout and clinical joint assessments in patients remaining in study through week 52 (n = 10)

	Baseline^a	Week 52	Change from baseline	p-value
Serum uric acid, mean ± SD, mg/dL	9.3 ± 3.0	1.1 ± 2.5	− 8.2 ± 4.1	0.0001
Number of joints affected by gout, mean ± SD
Swollen joints (66 count)	6.0 ± 8.0	0.4 ± 1.3	− 5.6 ± 7.7	0.048
Tender joints (68 count)	9.6 ± 11.9	1.2 ± 2.0	− 8.4 ± 10.8	0.036
Joints affected by tophi	7.2 ± 9.2	1.2 ± 2.3	− 6.0 ± 7.0	0.024
Health Assessment Questionnaire (HAQ), mean ± SD
Disability index (MCID = − 0.22)	0.8 ± 0.9	0.1 ± 0.2	− 0.66 ± 0.88	0.041
HAQ pain score (MCID = 10)	39.8 ± 24.3	6.2 ± 8.6	− 33.6 ± 25.2	0.002
HAQ health score (MCID = 10)	41.2 ± 30.9	29.0 ± 39.4	− 12.2 ± 54.8	0.499
Global Assessments of Gout, mean ± SD
Patient assessment (MCID = 1)	5.7 ± 2.0	1.1 ± 1.3	− 4.6 ± 2.1	< 0.0001
Physician assessment (MCID = 1)	6.0 ± 2.8	0.3 ± 0.5	− 5.7 ± 2.6	< 0.0001

Eight patients remained on pegloticase + methotrexate co-therapy thru week 52; 2 patients met treatment goals at week 24, discontinuing pegloticase + methotrexate co-therapy, remaining in study, and beginning allopurinol at the treating physician’s discretion
^aBaseline value was the last measurement obtained prior to the first pegloticase infusion. HAQ Disability Index range: 0 to 3 (higher score indicates worse disability). HAQ pain range: 0 (no pain) to 100 (severe pain). HAQ health range: 0 (very well) to 100 (very poor). Global Assessment range: 0 (excellent) to 10 (very poor)

ISSN: 1478-6362