TY - JOUR
T1 - Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment
T2 - final 2-year results from the multicenter phase IV C-VIEW study
AU - van der Horst-Bruinsma, Irene E.
AU - van Bentum, Rianne E.
AU - Verbraak, Frank D.
AU - Deodhar, Atul
AU - Rath, Thomas
AU - Hoepken, Bengt
AU - Irvin-Sellers, Oscar
AU - Thomas, Karen
AU - Bauer, Lars
AU - Rudwaleit, Martin
N1 - Publisher Copyright:
© The Author(s), 2021.
PY - 2021
Y1 - 2021
N2 - Introduction: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU. Patients and methods: C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks’ CZP versus 2 years pre-baseline. Results: Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12–0.28), p < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified. Conclusion: CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU. Trial Registration ClinicalTrials.gov: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992 SAGE-Journals-Accessible-Video-Player10.1177/1759720X211003803.M1sj-vid-1-tab-10.1177_1759720X211003803
AB - Introduction: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU. Patients and methods: C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks’ CZP versus 2 years pre-baseline. Results: Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12–0.28), p < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified. Conclusion: CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU. Trial Registration ClinicalTrials.gov: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992 SAGE-Journals-Accessible-Video-Player10.1177/1759720X211003803.M1sj-vid-1-tab-10.1177_1759720X211003803
KW - TNF inhibitor
KW - axial spondyloarthritis
KW - extra-articular manifestations
KW - uveitis
UR - http://www.scopus.com/inward/record.url?scp=85103417488&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85103417488&partnerID=8YFLogxK
U2 - 10.1177/1759720X211003803
DO - 10.1177/1759720X211003803
M3 - Article
AN - SCOPUS:85103417488
SN - 1759-720X
VL - 13
JO - Therapeutic Advances in Musculoskeletal Disease
JF - Therapeutic Advances in Musculoskeletal Disease
ER -