Table 4

Safety of non-biological drugs (observational studies)

Embedded Image

  • Bold=significant (p<0.05).

  • Kristensen 2015: Register-based cohort—r-axSpA and spondyloarthritis; median age in the cohort—46 years; follow-up—2006-2009 (3 years).

  • Essers 2016: Claims data set—patients with r-axSpA (n=3640) compared with general population (n=25 299); both groups—83% <60 years; follow-up—1987–2012 (25 years).

  • Zhang 2015: Data from Rheumatology Outpatient Department of the First Affiliated Hospital of Shantou University Medical College in China—r-axSpA (n=830); low-dose GC—10 mg prednisone/10 mg methylprednisolone; duration mean (SD)—1.7 (1.6) years; NSAIDs—90 mg acemetacin or 50 mg indomethacin or 7.5 mg meloxicam.

  • *Atherosclerotic events=cardiac and cardiovascular.

  • †Patients with r-axSpA with or without recent NSAID use were compared with all controls, irrespective of the use of NSAIDs in the control group.

  • aHR, adjusted HR; aIR, adjusted incidence rate; aRR, adjusted relative risk; CI, confidence interval; COX, cyclooxygenase; DAE, dermatological adverse events; GC, glucocorticoids; GI, gastrointestinal; IHD, ischaemic heart disease; IR, incidence rate; NR, not reported; NSAID, non-steroidal anti-inflammatory drug; py, patient-years; r-axSpA, radiographic axial spondyloarthritis; ref, reference.