Occurrence of paradoxical adverse events in European and American registries
| Registry Reference | PAE | Disease | Biological agent | Number of participants | Results |
|---|---|---|---|---|---|
| British society for rheumatology biologics register (BSRBR, UK)10 | Psoriasis | RA | Anti-TNF-α agents | 9826 anti–TNF-α- treated patients 2880 DMARD-treated patients | Incident rate ratio for 1000 person-years (95% CI): Global: 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)11 | Psoriasis | Anti-TNF-α agents | Incident rate/1000 patient-year: 2.31 (1.69–2.35)adalimumab: 3.2 (1.8–5.8) (etanercept:) 2 (1.1–3.6) Infliximab: 2.2 (1.4–3.4) | ||
| Autoimmunity and rituximab registry (AIR, France)14 | Psoriasis | RA | Rituximab | 1927 | Incident 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, Italy33 | IBD | JIA | Etanercept | ND | Incidence rate of IBD/100 000 person-years: 362 |
| A WHO adverse event database (Sweden) and National registry of drug-induced ocular side effects (USA)41 | Uveitis | RA, SpA, PsA and CD | Anti-TNF-α\xEF\x80 agents | ND | 43 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)43 | Uveitis | AS | Anti–TNF-α agents | 1385 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)44 | Uveitis | JIA | Anti-TNF-α agents or MTX | 3467 | Rate 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.