Background/Purpose: Spondyloarthropathies (SpA) encompass a heterogeneous group of chronic inflammatory diseases affecting axial and peripheral joints. Besides articular symptoms, patients also experience extra-articular manifestations (EAMs) including uveitis, psoriasis, inflammatory bowel disease (IBD) and multiple organ involvement. The aim of this analysis was to describe the incidence of new onset EAMs focusing on uveitis and IBD among SpA pts over 6 and 12 months of treatment with golimumab (GLM).

Methods: BioTRAC is an ongoing, prospective registry of patients initiating treatment with infliximab or GLM for RA, AS, or PsA, or with ustekinumab for PsA. Eligible participants for this analysis comprised GLM-treated AS (n=395) and PsA (n=257) patients. Presence of EAMs was defined as patients with uveitis or IBD.  IBD data, however, was not collected for PsA pts.  Results were based on patients with available data. Safety was ascertained by the incidence of adverse events (AEs) and serious adverse events (SAEs), reported per 100 pt years (PY) of follow-up.

Results: Among AS pts, at baseline, the mean (SD) age was 45.3 (13.5) years and CRP was 14.1 (30.5) mg/L. Positive HLA B27 status was reported for 174 (174/264; 65.9%) pts. History of uveitis was reported among 14.2% (n=50/352) of AS pts. EAMs are reported over time in Table 1. New-onset uveitis and IBD was reported for 2.3% (3.2 events/100 PY) and 1.1% (1.5 events/100 PY) of pts during follow-up, respectively. Results showed that CRP and HLA B27 status were not significantly associated with presence of EAMs at baseline. Overall, 419 AEs and 26 SAEs were reported by 199 (50.4%) and 16 (4.1%) pts by 12 months of treatment, respectively, for a total of 144.1 AEs/100 PY and 8.9 SAEs/100 PY.  A total of 5 AEs of uveitis were reported all of which were of mild severity, and either not (n=4) or unlikely related (n=1) to the study drug.

Among PsA pts, the mean (SD) age was 52.7 (13.2) years and CRP was 13.2 (32.4) mg/L at baseline. A total of 9 (9/80; 11.3%) pts had positive HLA B27 status. Patients with a history of uveitis was reported for 1.8% (n=4/224) of PsA pts. New-onset uveitis was reported for 0.4% (0.5 events/100 PY) of patients during follow-up. Overall, 254 AEs and 15 SAEs were reported by 123 (47.9%) and 12 (4.7%) patients by 12 months of treatment, respectively, for a total of 135.0 AEs/100 PY and 8.0 SAEs/100 PY. 

Table 1. EAMs over Time and New Onset since Baseline

Patients with unknown EAM were excluded from the analysis. *Denominator (N) represents patients at risk at the respective visit relative to the previous visit. ^¥Average follow-up per patient was 8.8 months for AS and 9.8 months for PsA. NA=not applicable

Conclusion: In patients with AS, development of uveitis and IBD was 2.3% and 1.1% during 12-month follow-up of GLM-treatment. Among PsA patients, lower rates of new-onset uveitis were observed with 0.4%. The current results should be interpreted with caution given the low number of cases of uveitis and IBD.