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Spondyloarthritis
Original article
The impact of certolizumab pegol treatment on the incidence of anterior uveitis flares in patients with axial spondyloarthritis: 48-week interim results from C-VIEW
  1. Irene van der Horst-Bruinsma1,
  2. Rianne van Bentum1,
  3. Frank D Verbraak2,
  4. Thomas Rath3,
  5. James T Rosenbaum4,5,
  6. Maria Misterska-Skora6,
  7. Bengt Hoepken7,
  8. Oscar Irvin-Sellers8,
  9. Brenda VanLunen9,
  10. Lars Bauer7 and
  11. Martin Rudwaleit10,11
  1. 1Department of Rheumatology, Amsterdam University Medical Center, Location VU Medical Center, Amsterdam, The Netherlands
  2. 2Department of Ophthalmology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands
  3. 3St Franziskus-Hospital,Münster, Germany
  4. 4Devers Eye Institute, Legacy Health System, Portland, Oregon, USA
  5. 5Oregon Health and Science University, Portland, Oregon, USA
  6. 6Department of Rheumatology and Internal Medicine, Wrocław Medical University, Wrocław, Poland
  7. 7UCB Pharma, Monheim Am Rhein, Germany
  8. 8UCB Pharma, Slough, UK
  9. 9UCB Pharma, Raleigh, North Carolina, USA
  10. 10Klinikum Bielefeld and Charité Berlin, Berlin, Germany
  11. 11Ghent University, Ghent, Belgium
  1. Correspondence to Irene van der Horst-Bruinsma; IE.vanderHorst{at}amsterdamumc.nl

Abstract

Background Acute anterior uveitis (AAU) is the most common extra-articular manifestation in patients with axial spondyloarthritis (axSpA). C-VIEW investigates the impact of the Fc-free TNF inhibitor certolizumab pegol (CZP) on AAU flares in patients with active axSpA at high risk of recurrent AAU.

Methods C-VIEW (NCT03020992) is a 96-week ongoing, multicentre, open-label, phase 4 study. Included patients had an axSpA diagnosis, a history of recurrent AAU (≥2 AAU flares, ≥1 flare in the year prior to study entry), HLA-B27 positivity, active disease, and failure of ≥2 non-steroidal anti-inflammatory drugs. Patients received CZP 400 mg at Weeks 0/2/4, then 200 mg every 2 weeks up to 96 weeks. This 48-week pre-planned interim analysis compares AAU flare incidence in the 48 weeks before and after initiation of CZP treatment, using Poisson regression to account for possible within-patient correlations.

Results In total, 89 patients were included (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean axSpA disease duration: 8.6 years). During 48 weeks’ CZP treatment, 13 (15%) patients experienced 15 AAU flares, representing an 87% reduction in AAU incidence rate (146.6 per 100 patient-years (PY) in the 48 weeks pre-baseline to 18.7 per 100 PY during CZP treatment). Poisson regression analysis showed that the incidence rate of AAU per patient reduced from 1.5 to 0.2 (p<0.001). No new safety signals were identified.

Conclusions There was a significant reduction in the AAU flare rate during 48 weeks of CZP treatment, indicating that CZP is a suitable treatment option for patients with active axSpA and a history of recurrent AAU.

  • uveitis
  • TNF inhibitor
  • axial spondyloarthritis
  • extra-articular manifestations
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/rmdopen-2019-001161

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    Footnotes

    • Contributors IvdHB, FDV, TR, BH, OIS, BVL, LB, and MR have substantially contributed to study conception and design; IvdHB, RvB, FDV, TR, JTR, MMS, BH, OIS, LB, and MR have substantially contributed to analysis and interpretation of the data; IvdHB, RvB, FDV, TR, JTR, MMS, BH, OIS, BVL, LB, MR were involved in drafting the article or revising it critically for important intellectual content and gave final approval of the version of the article to be published.

    • Funding This study was funded by UCB Pharma.

    • Competing interests Yes, there are competing interests for one or more authors and I have provided a Competing Interests statement in my manuscript.

    • Disclosures IvdHB: Honoraria/consulting fees/research grants from AbbVie, BMS, MSD, Novartis, Pfizer, UCB Pharma; RVB: none; FDV: Honoraria/consulting fees/research grants from Bayer, Novartis, IDxDR, UCB Pharma; TR: Honoraria/consulting fees from AbbVie, BMS, Chugai, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma; JTR: Consultancy fees from UCB Pharma, AbbVie, Celldex, Gilead, Novartis, Janssen, Santen, Roche, Eyevensys, Corvus, Horizon; royalties from UpToDate; clinical trial support from Pfizer; MMS: none; BH, OIS, BVL, LB: Employees of UCB Pharma; MR: Honoraria/consulting fees from AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma.

    • Patient consent for publication Not required.

    • Data sharing statement Underlying data from this manuscript may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymised individual patient-level data and redacted trial documents which may include: analysis-ready data sets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password-protected portal.

    • Provenance and peer review Not commissioned; internally peer reviewed.