Abstract | BACKGROUND:
Gout is a heterogeneous inflammatory disease with numerous clinical manifestations. A composite means to assess the impact of therapy on numerous aspects of gout could be useful. METHODS: Results from patients treated with pegloticase or placebo in two randomized clinical trials and their open-label extension were assessed using a novel evidence-based Gout Multivariable Improvement Measure (GMIM) derived from previously reported criteria for remission and complete response. Improvement was defined as serum urate (sU) < 6 mg/dL and absence of flares during the preceding 3 months plus 20, 50, and 70% improvement in tophus size, patient global assessment, pain, and swollen and tender joints. RESULTS: Patients treated with pegloticase manifested a significantly greater GMIM20, 50, and 70 response vs those treated with placebo (GMIM20 at 6 months 37.1% vs 0%, respectively). Higher response rates were significantly more frequent in subjects with persistent urate lowering (GMIM 58.1% at 6 months) in response to pegloticase versus those with only transient urate lowering (GMIM 7.1% at 6 months). However, when the requirement for a decrease in sU to < 6 mg/dL was omitted, a substantial percentage of subjects with transient urate lowering met the GMIM clinical criteria. A sensitivity analysis indicated that gout flares contributed minimally to the model. The response measured by GMIM persisted into the open-level extension for as long as 2 years. Finally, subjects who received placebo in the randomized control trials, but pegloticase in the open-label extension, manifested GMIM responses comparable to that noted with pegloticase-treated subjects in the randomized controlled trials. CONCLUSIONS: GMIM captures changes in disease activity in response to treatment with pegloticase and may serve as an evidence-based tool for assessment of responses to other urate-lowering therapies in gout patients.
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Authors | Naomi Schlesinger, N Lawrence Edwards, Anthony E Yeo, Peter E Lipsky |
Journal | Arthritis research & therapy
(Arthritis Res Ther)
Vol. 22
Issue 1
Pg. 164
(06 29 2020)
ISSN: 1478-6362 [Electronic] England |
PMID | 32600452
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Gout Suppressants
- Uric Acid
- Polyethylene Glycols
- Urate Oxidase
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Topics |
- Arthritis, Gouty
(drug therapy)
- Chronic Disease
- Gout
(diagnosis, drug therapy)
- Gout Suppressants
(therapeutic use)
- Humans
- Polyethylene Glycols
(therapeutic use)
- Treatment Outcome
- Urate Oxidase
(therapeutic use)
- Uric Acid
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