Table 2.

Pegloticase with leflunomide co-therapy details and list of adverse events

Patient number	Leflunomide initiationa (days)	Number of pegloticase infusions	Pegloticase therapy durationb (weeks)	SU at Inf 12 (mg/dl)	Treatment responder? (If no, reason)	Adverse events
1	+ 30	9	16	–	No—Discontinued therapy due to AEs (deemed unrelated to co-therapy)	Three gout flares, worsening of CHF (not-related)
2	− 11	22	48	0.1	Yes	Mild, transient increase liver function tests (after infusions 6 and 18)
3	− 14	13	23	2.0	Yes	Loss of consciousness (infusion 11), reaction to solumedrol (prior to infusion 14)
4	+ 189	6	33	–	No—Lost to follow-up after infusion 6. Note: Patient had a 6-month treatment interruption between infusions 4 and 5 because of insurance issues. Leflunomide started prior to infusion 5	–
5	+ 35	22	56	0.1	Yes	–
6	+ 98	22	45	0.1	Yes	–
7†	− 210	27, 19, 9	57, 37, 16	0.1	Yes	–
8	0	34	71	3.8	Yes	–
9	− 77	6	12	–	No—Discontinued upon entering hospice	–
10	− 36	18	35	0.1	Yes	–
Mean ± SD	0.4 ± 104.9	20.7 ± 14.9	–	0.9 ± 1.5	7 (70%)	–
Median	− 5.5	20	40.1	0.1	–	–

CHF congestive heart failure, CKD chronic kidney disease, SD standard deviation

^aAll patients treated with 10 mg/day oral leflunomide for 7 days then 20 mg/day; time zero defined as the date of pegloticase infusion 1, − indicates prior to infusion 1, + indicates after infusion 1

^bTherapy duration calculated as time between first and last pegloticase dose

^cPatient 7 had been taking leflunomide as treatment for seronegative rheumatoid arthritis. The patient received two complete courses of pegloticase/leflunomide co-therapy (separated by 9 months) and was receiving a 3rd ongoing course at data collection (6 months gap between courses 2 and 3)