title: Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Klinikum Bielefeld, Bielefeld, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Rudwaleit
authors.affiliation: Devers Eye Institute, Legacy Health System, Portland, Oregon, and Oregon Health & Science University, Portland.
authors.forename: J T
authors.initials: JT
authors.lastname: Rosenbaum
authors.affiliation: Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, the Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: Landewé
authors.affiliation: Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors.forename: H
authors.initials: H
authors.lastname: Marzo-Ortega
authors.affiliation: University Hospital Charité, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Sieper
authors.affiliation: Leiden University Medical Centre, Leiden, the Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: van der Heijde
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: O
authors.initials: O
authors.lastname: Davies
authors.affiliation: UCB Pharma, Monheim, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Bartz
authors.affiliation: UCB Pharma, Monheim, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Hoepken
authors.affiliation: UCB Pharma, Monheim, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Nurminen
authors.affiliation: Oregon Health & Science University, Portland.
authors.forename: A
authors.initials: A
authors.lastname: Deodhar
mesh_terms: D000328:Adult; D000068582:Certolizumab Pegol / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D025241:Spondylarthritis / Q000188:drug therapy*; D014605:Uveitis / Q000453:epidemiology*
chemical_list: D007166:Immunosuppressive Agents; D000068582:Certolizumab Pegol
references.citation: J Rheumatol. 2013 Dec;40(12):2038-41
references.pmid: 24187102
references.citation: Ophthalmology. 2014 Mar;121(3):785-96.e3
references.pmid: 24359625
references.citation: Joint Bone Spine. 2011 Dec;78(6):598-603
references.pmid: 21458351
references.citation: Eye (Lond). 2000 Jun;14 ( Pt 3A):340-3
references.pmid: 11026996
references.citation: J Rheumatol Suppl. 2006 Sep;78:4-11
references.pmid: 17042055
references.citation: J Rheumatol. 2001 Dec;28(12 ):2667-73
references.pmid: 11764216
references.citation: Arthritis Rheum. 2005 Aug;52(8):2447-51
references.pmid: 16052578
references.citation: Ther Adv Musculoskelet Dis. 2012 Dec;4(6):413-22
references.pmid: 23227118
references.citation: Nat Rev Rheumatol. 2012 Apr 03;8(5):249-50
references.pmid: 22469907
references.citation: Arthritis Rheum. 2007 Oct;56(10):3248-52
references.pmid: 17907169
references.citation: Mediators Inflamm. 2013;2013:286857
references.pmid: 23983404
references.citation: Clin Exp Rheumatol. 2002 Nov-Dec;20(6 Suppl 28):S143-5
references.pmid: 12463466
references.citation: Semin Arthritis Rheum. 2011 Dec;41(3):503-10
references.pmid: 21862108
references.citation: Eye (Lond). 2009 May;23(5):1130-3
references.pmid: 18688259
references.citation: Arthritis Care Res (Hoboken). 2012 Sep;64(9):1415-22
references.pmid: 22505331
references.citation: Ann Rheum Dis. 2014 Jan;73(1):39-47
references.pmid: 24013647
references.citation: Rheum Dis Clin North Am. 2012 Aug;38(3):523-38
references.pmid: 23083753
references.citation: Ocul Immunol Inflamm. 2016;24(2):167-72
references.pmid: 25325834
references.citation: J Rheumatol. 2003 Jun;30(6):1277-9
references.pmid: 12784403
references.citation: Ann Rheum Dis. 2014 Jan;73(1):6-16
references.pmid: 23749611
references.citation: Ann Rheum Dis. 2009 May;68(5):696-701
references.pmid: 18662932
references.citation: Ann Rheum Dis. 2010 Jan;69(1):226-9
references.pmid: 19465402
references.citation: Arthritis Rheum. 2009 Mar;60(3):717-27
references.pmid: 19248087
references.citation: Ophthalmology. 2002 Dec;109(12):2342-6
references.pmid: 12466181
references.citation: Arch Ophthalmol. 2001 Jun;119(6):841-9
references.pmid: 11405835
references.citation: BMC Musculoskelet Disord. 2015 Feb 10;16:19
references.pmid: 25888248
references.citation: Rev Rhum Ed Fr. 1993 Jan;60(1):81-3
references.pmid: 7902159