Table 2

Occurrence of paradoxical adverse events in European and American registries

PAEDiseaseBiological agentNumber of participantsResults
British society for rheumatology biologics register (BSRBR, UK)10PsoriasisRAAnti-TNF-α agents9826 anti–TNF-α- treated patients 2880 DMARD-treated patientsIncident rate ratio for 1000 person-years (95% CI):
1.04 (0.67–1.54)
Adalimumab vs etanercept :
4,6 (1.7–12.1)
Adalimumab vs Infliximab: 3.5 (1.3–9.3)
Spanish registry for adverse events of biological therapy in rheumatic diseases (BIOBADASER, Spain)11PsoriasisAnti-TNF-α agentsIncident rate/1000 patient-year:
2.31 (1.69–2.35)adalimumab:
3.2 (1.8–5.8) (etanercept:) 2 (1.1–3.6)
2.2 (1.4–3.4)
Autoimmunity and rituximab registry (AIR, France)14PsoriasisRARituximab1927Incident rate/1000 person-years (95%CI):
New-onset psoriasis:
1.04 (0.13–3.8)
Flare of pre-existing psoriasis:
2.6 (0.84–6.1)
Registry from the Netherlands, Germany, Finland, Denmark, Italy33IBDJIAEtanerceptNDIncidence rate of IBD/100 000 person-years: 362
A WHO adverse event database (Sweden) and National registry of drug-induced ocular side effects (USA)41UveitisRA, SpA, PsA and CDAnti-TNF-α\xEF\x80 agentsND43 cases associated with etanercept, 14 with infliximab and 2 with adalimumab.
(the higher number of uveitis with etanercept persists after excluding patients whose uveitis may result from the underlying disease)
Swedish biologic registry (ARTIS, Sweden)43UveitisASAnti–TNF-α agents1385
Adalimumab: 406
Etanercept: 354
Infliximab: 605
Flare of uveitis before and after anti-TNF-a agent initiation/100 person-years (95% CI)
Adalimumab 12.9 (11.7–14.2) and 7.7 (5.9–9.6)
Etanercept: 9.6 (9.4–10.9) and 20.2 (17.5–22.8)
Infliximab: 12.7 (11.5–13.8) and 11.7 (10.1–13.3)
German Biologics in Pediatric Rheumatology (BIKER, Germany)44UveitisJIAAnti-TNF-α agents or MTX3467Rate of uveitis
MTX: 51/2884
Etanercept: 37/1700
Adalimumab: 13/364
Rate of new uveitis: MTX: 3.2/1000 person-years
Etanercept: 1.9/1000 person-years
Etanercept+MTX: 0.9/1000 person-years
  • CD, Crohn's disease; DMARD, disease modifying antirheumatic drugs; IBD, inflammatory bowel disease; JIA, juvenile idiopathic arthritis; PAE, paradoxical adverse event; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SpA, spondyloarthritis.