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Pauline Merrill, Albert T Vitale, Manfred Zierhut, Eric Fortin, Hiroshi Goto, Martina Kron, Samir R Tari, Sophia Pathai; Adalimumab in non-infectious uveitis – efficacy across different etiologies in the VISUAL I and VISUAL II trials. Invest. Ophthalmol. Vis. Sci. 2017;58(8):518.
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To assess adalimumab (ADA) efficacy in active and inactive, non-infectious uveitis across different etiologies in patients who were recruited as part of the VISUAL program.
Exploratory data analyses from two global phase 3, double-masked trials: VISUAL I (patients with active uveitis despite ≥2 weeks of prednisone 10–60 mg/day) and VISUAL II (patients with inactive disease dependent on 10–35 mg/day of prednisone to maintain inactivity) were performed. Patients received placebo (PBO) or ADA subcutaneously (80 mg week 0, followed by 40 mg every other week from week 1 up to 80 weeks). In VISUAL I, all patients received a prednisone burst followed by taper to 0 mg by week 15. In VISUAL II, prednisone taper to 0 mg was mandatory by week 19. The primary endpoint was time to treatment failure (TF) at or after week 6 for VISUAL I; and at or after week 2 for VISUAL II 1, 2. For this analysis, patients were categorized into different uveitis etiologies which they presented at study entry. Hazard ratios (HR) for time to TF were obtained for each uveitis etiology.
The efficacy of ADA was significantly greater than PBO in the largest subgroup of patients with Idiopathic/other uveitis (VISUAL I: 103 and VISUAL II: 90) etiology in both VISUAL I1 and VISUAL II trials. All other subgroups showed a trend in favor of ADA, except for Sarcoidosis subgroup in the VISUAL II trial (Figure). Overall safety for both trials has been previously reported 1,2.
These exploratory analyses from the VISUAL I and VISUAL II trials show significantly higher efficacy in ADA-treated patients over PBO in ‘idiopathic/other’ diagnoses of patients with both active and inactive non-infectious uveitis. Furthermore, across different uveitis etiologies, these analyses suggest that ADA-treated patients had a prolonged time to treatment failure compared to PBO.References:1) Jaffe GJ, Dick AD, Brezin AP, et al. N Engl J Med (2016); 375:932-432) Nguyen QD, Merrill PT, Jaffe GJ, et al. The Lancet (2016); 388(10050): 1183-92
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
Figure: Hazard ratios of time to treatment failure by uveitis etiologies. VISUAL I (A) and VISUAL II* (B) clinical trials.
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