Proceedings of the 24th Paediatric Rheumatology European Society Congress: Part two

Table 17 (Abstract P246). Summary of Patients with AEs During the Combined Initial 4-Month and 20-Month Extension Period in the 6–17-Year Cohort (n = 173)

Event	n = 173
Deaths	0
SAEs	14 (8.1)*
Related SAEs	1 (0.6)^†
SAEs leading to discontinuation	4 (2.3)^‡
All AEs^§	152 (87.9)
Related AEs	54 (31.2)
AEs leading to discontinuation	7 (4.0)^¶
AEs of special interest
Malignancies	1 (0.6)**
Autoimmune disorders	3 (1.7)
Local injection-site reactions	12 (6.9)
Infections	42 (24.3)

Data are n (%)
*Sepsis, abdominal pain and upper respiratory tract infection (occurred in one patient), appendicitis, pneumonia, pyelonephritis, concussion, radius fracture, urinary calculus, nephrolithiasis, anaemia, vertigo, chest pain, synovitis, hypomagnesaemia and ovarian germ cell teratoma stage III (occurred in one patient), autonomic nervous system imbalance
^†Sepsis
^‡Sepsis, vertigo, ovarian germ cell teratoma stage III, autonomic nervous system imbalance
^§No opportunistic infections, including extra-pulmonary tuberculosis occurred during the study. One case of latent tuberculosis was reported (mild, not related to abatacept treatment, drug was interrupted, treatment was required)
^¶Ovarian germ cell teratoma stage III, fatigue, sepsis, exanthema, autonomic nervous system imbalance, aphthous ulcer, vertigo
**Ovarian germ cell teratoma stage III
SAE = serious AE

ISSN: 1546-0096