Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis

M Rudwaleit; J T Rosenbaum; R Landewé; H Marzo-Ortega; J Sieper; D van der Heijde; O Davies; H Bartz; B Hoepken; T Nurminen; A Deodhar

doi:10.1002/acr.22848

Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis

Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.

Authors

M Rudwaleit¹, J T Rosenbaum², R Landewé³, H Marzo-Ortega⁴, J Sieper⁵, D van der Heijde⁶, O Davies⁷, H Bartz⁸, B Hoepken⁸, T Nurminen⁸, A Deodhar⁹

Affiliations

¹ Klinikum Bielefeld, Bielefeld, Germany.
² Devers Eye Institute, Legacy Health System, Portland, Oregon, and Oregon Health & Science University, Portland.
³ Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, the Netherlands.
⁴ Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
⁵ University Hospital Charité, Berlin, Germany.
⁶ Leiden University Medical Centre, Leiden, the Netherlands.
⁷ UCB Pharma, Slough, UK.
⁸ UCB Pharma, Monheim, Germany.
⁹ Oregon Health & Science University, Portland.

Abstract

Objective: Axial spondyloarthritis (axial SpA) is characterized by inflammation of the spine and sacroiliac joints and can also affect extraarticular sites, with the most common manifestation being uveitis. Here we report the incidence of uveitis flares in axial SpA patients from the RAPID-axSpA trial, including ankylosing spondylitis (AS) and nonradiographic (nr) axial SpA.

Methods: The RAPID-axSpA (NCT01087762) trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Patients were randomized to certolizumab pegol (CZP) or placebo. Placebo patients entering the dose-blind phase were re-randomized to CZP. Uveitis events were recorded on extraarticular manifestation or adverse event forms. Events were analyzed in patients with/without history of uveitis, and rates reported per 100 patient-years.

Results: At baseline, 38 of 218 CZP-randomized patients (17.4%) and 31 of 107 placebo-randomized patients (29.0%) had past uveitis history. During the 24-week double-blind phase, the rate of uveitis flares was lower in CZP (3.0 [95% confidence interval (95% CI) 0.6-8.8] per 100 patient-years) than in placebo (10.3 [95% CI 2.8-26.3] per 100 patient-years). All cases observed during the 24-week double-blind phase were in patients with a history of uveitis; in these patients, rates were similarly lower for CZP (17.1 [95% CI 3.5-50.1] per 100 patient-years) than placebo (38.5 [95% CI 10.5-98.5] per 100 patient-years). Rates of uveitis flares remained low up to week 96 (4.9 [95% CI 3.2-7.4] per 100 patient-years) and were similar between AS (4.4 [95% CI 2.3-7.7] per 100 patient-years) and nr-axial SpA (5.6 [95% CI 2.9-9.8] per 100 patient-years).

Conclusion: The rate of uveitis flares was lower for axial SpA patients treated with CZP than placebo during the randomized controlled phase. Incidence of uveitis flares remained low to week 96 and was comparable to rates reported for AS patients receiving other anti-tumor necrosis factor antibodies.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Certolizumab Pegol / therapeutic use*
Double-Blind Method
Female
Humans
Immunosuppressive Agents / therapeutic use*
Incidence
Male
Middle Aged
Spondylarthritis / drug therapy*
Uveitis / epidemiology*

Substances

Immunosuppressive Agents
Certolizumab Pegol

Associated data

ClinicalTrials.gov/NCT01087762