Incidence of uveitis flares occurred at a lower rate in patients with axial spondyloarthritis (SpA) treated with certolizumab pegol (CZP) and at rates comparable to those treated with anti-tumor necrosis factor (TNF) antibodies, according to research published in Arthritis Care & Research.
A total of 325 participants in the RAPID-axSpA phase 3, multicenter trial were randomly assigned to receive either CZP (200 mg every 2 weeks or 400 mg every 4 weeks following a 400-mg loading dose at weeks 0, 2, 4) or placebo. Placebo patients entering the dose-blind phase were then re-randomized to receive a CZP loading dose followed by CZP 200 mg every 2 weeks or 400 mg every 4 weeks after week 24, or at week 16 for nonresponders. At baseline, 17.4% of patients receiving CZP and 29% of patients receiving placebo had a history of past uveitis. The proportion of patients with a history of uveitis was similar in the ankylosing spondylitis and nonradiographic axial SpA subpopulations (20.8% and 21.1%, respectively).
In week 24 analyses, the occurrence of uveitis events was compared between the CZP and the placebo groups. In weeks 48 and 96, all patients who received at least 1 dose of CZP were included.
“All cases observed during the 24-week double-blind phase were in patients with a history of uveitis,” wrote Martin Rudwaleit, MD, Department of Internal Medicine and Rheumatology in Bielefeld, Germany, and colleagues. “Rates of uveitis flares remained low up to week 96 (4.9 [3.2-7.4]/100 patient-years [PY]) and were similar between ankylosing spondylitis (4.4 [2.3-7.7]/100 PY) and nonradiographic axial SpA (5.6[2.9-9.8]/100 PY).” The incidence rate of uveitis flares was lower for patients with axial SpA treated with CZP compared with placebo during the randomized controlled phase and was comparable to the rate reported for patients with ankylosing spondylitis receiving anti-TNF therapy.
Long-term data indicated that the overall rate of uveitis flares remained similar throughout the dose-blind (to week 48) and open-label (to week 96) periods. Uveitis rates in patients with a prior history also remained stable.
Summary and Clinical Applicability
The results of this study suggest that CZP has an impact on reducing uveitis flares in patients with axial SpA, including both the ankylosing spondylitis and nonradiographic axial SpA subpopulations. Further data are required from prospective studies to confirm these findings.
Rudwaleit M, Rosenbaum JT, Landewé R, el al. Observed incidence of uveitis following certolizumab pegol treatment in patients with axial spondyloarthritis. Arthrit Care Res. 2016; doi: 10.1002/acr.22848 [Epub ahead of print]