Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Data generated by Phase 1 and 2 studies suggest that the extended-release (XR) formulation of febuxostat (FBX) may provide equal or better reduction in serum urate level (sUA) in patients (pts) with gout, with reduced exposure (Cmax and AUC), compared with the immediate-release (IR) formulation. This Phase 3 study was conducted to evaluate the efficacy and safety of FBX XR compared with FBX IR in gout pts with normal or impaired renal function.
Methods: In a Phase 3, multicenter, randomized, placebo-controlled, double-blind study, pts with gout (sUA ≥8.0 mg/dL, estimated glomerular filtration rate ≥15 mL/min, and ≥1 gout flare within the previous 12 months) received placebo or FBX XR 40 mg, XR 80 mg, IR 40 mg, or IR 80 mg once daily for 3 months. The primary endpoint was the proportion of pts with sUA <5.0 mg/dL at Month 3. Secondary endpoints were proportions of pts with at least 1 flare requiring treatment during the 3-month treatment period and of pts with sUA <6.0 mg/dL at Month 3.
Results: A total of 1783 pts received treatment with placebo (n=357) or FBX XR 40 mg (n=355), XR 80 mg (n=357), IR 40 mg (n=357), or IR 80 mg (n=357). A higher proportion of pts receiving FBX XR 40 mg achieved sUA <5.0 mg/dL versus (vs) IR 40 mg at Month 3 (25.9% vs 15.7%, respectively; p=0.001). Although the difference was not statistically significant, more FBX XR 80-mg treated pts achieved the primary endpoint compared with IR 80 mg (50.1% vs 42.6%, respectively). Neither FBX XR treatment group differentiated from its respective IR treatment group for the secondary endpoint of proportion of pts with at least 1 flare requiring treatment during the 3-month treatment period. A numerically higher proportion of pts achieved sUA <6.0 mg/dL with FBX XR 40 mg compared with IR 40 mg (48.2% vs 40.3%, respectively), and the observed difference between FBX XR 80 mg vs IR 80 mg for this endpoint was small (61.1% vs 57.7%, respectively). Primary and secondary endpoint results are shown (Figure). Treatment-emergent and treatment-related adverse events were infrequent and generally did not differ among treatment groups.
Conclusion: Significantly more pts receiving FBX XR 40 mg achieved the primary endpoint of sUA reduction to <5.0 mg/dL at the Month 3 visit compared with FBX IR 40 mg. Overall, the incidence rates of treatment-emergent and treatment-related adverse events were low. Both FBX formulations were efficacious in lowering sUA and were generally well tolerated.
To cite this abstract in AMA style:Saag K, Becker MA, Whelton A, Hunt B, Castillo M, Kisfalvi K, Gunawardhana L. A Phase 3 Study to Evaluate the Efficacy and Safety of Febuxostat Extended- Versus Immediate-Release Formulations in Patients with Gout [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/a-phase-3-study-to-evaluate-the-efficacy-and-safety-of-febuxostat-extended-versus-immediate-release-formulations-in-patients-with-gout/. Accessed December 1, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-phase-3-study-to-evaluate-the-efficacy-and-safety-of-febuxostat-extended-versus-immediate-release-formulations-in-patients-with-gout/