Long-Term Adalimumab Reduces Uveitis and Corticosteroid Dose
WASHINGTON, DC—Adalimumab (Humira; AbbVie) helps treat non-infectious intermediate, posterior, or panuveitis (NIPPU), according to findings from an open-label clinical trial extension, VISUAL-III, presented at the 2016 ACR/ARHP Annual Meeting.
“Long-term adalimumab treatment reduced ocular inflammation and corticosteroid burden in NIPPU patients and demonstrated a safety profile consistent with other indications and previous VISUAL studies,” reported coauthor Samir Tari, MD, of AbbVie Inc., in North Chicago, IL.
Participants in the VISUAL-III trial extension (n=424) were adults who completed study participation or experienced treatment-failure criteria in the VISUAL-I/VISUAL-II trials. They received adalimumab 40mg every other week, with corticosteroids and/or immunosuppressive therapy as needed.
Efficacy was assessed with measures of new inflammatory chorioretinal/retinal vascular lesions, anterior chamber (AC) cell ≤0.5+, and vitreous haze (VH) grades ≤0.5+, number of patients with macular edema, and mean corticosteroid daily dose from baseline (Week 0) through Week 54 (inactive uveitis), and at Week 78 (active uveitis). Corticosteroid doses were measured and adverse events recorded.
“Intent-to-treat analyses included 243 (active) and 128 (inactive) uveitis patients at study entry,” Dr. Tari reported. “At Week 54, no new inflammatory lesions relative to baseline, AC cell and VH grades of ≤0.5+ were observed in 98.5%, 98.5% and 92.6% of inactive uveitis patients, respectively.”
At Week 78, “no new inflammatory lesions relative to Week 8, AC cell and VH grades of ≤0.5+ were observed in 96.3%, 91.0% and 87.8% of active uveitis patients,” Dr. Tari said. Also, the number of patients with macular edema declined by Week 78.
Mean systemic corticosteroid daily doses dropped from 8.8mg daily to 2.6mg daily by Week 78.
"Adverse events rates (577 adverse events per 100 person-years and 19.6 serious adverse events per 100 person-years) were comparable to the VISUAL-I and VISUAL-II trials,” Dr. Tari reported.