Table 3

Adverse events (AEs)

Part A (double-blind)Part 2 (M1–12) (open label)
Group 1Group 2
Adverse eventAnakinraPlaceboAnakinra
Number of patients (patient-years*)12 (1)12 (1)22 (15.17)
Any AE, no. (/patient-year)14 (14)13 (13)89 (5.71)
Serious AE, no. (/patient-year)0 (0)0 (0)5 (0.33)
Pain to injection, no. (/patient-year)8 (8)6 (6)15 (0.99)
Post-injection erythema, no.316 (0.40)
Infections, no. (/patient-year)2 (2)2 (2)44 (2.90)
 ENT infections and laryngitis, no.1120
 Bronchitis, no.008
 Gastroenteritis, no.113
 Skin infections, no.004
 Other infections, no.009§
Vomiting, abdominal pain, no.019
Other AE, no. (/patient-year)0 (0)2 (2)10 (0.66)
  • * Patient-years = 12 patients in each group followed up for 1 month during the double-blind phase, 22 patients exposed to study treatment for a total of 182 months during the open-label phase (eight patients were withdrawn from the trial between M1 and M6).

  • Disease activity/flares was not systematically recorded as an AE.

  • Infections in four patients, vertebral collapse in one patient (these five patients continued the trial), skin and digestive symptoms leading to the diagnosis of Crohn's disease in one patient.

  • § Varicella (n=3), vulvar candidiasis (n=2), isolated fever (n=2), atypical pneumonitis, urinary tract infection. Favourable outcome in all cases, no patient withdrawn from the trial.

  • Skin lesions (n=5), haematuria (n=2), back pain (n=2), dental fracture, asthenia, vertigo.