In children with inflammatory rheumatic disease, tocilizumab can cause serious side effects (AE), with younger children at the onset of the disease and at the time of initiation of tocilizumab especially affected.
A quarter of children with inflammation rheumatic disease those treated with tocilizumab experience serious side effects (SAE) and most serious infections, with younger children more vulnerable, according to a study published in Seminar on Arthritis and Rheumatism.
Researchers from France and Switzerland studied 104 children with systemic teenage idiopathic arthritis (n = 43) or polyarticular (n = 43). Patients have received at least 1 dose of tocilizumab at 2 French tertiary pediatric rheumatology centers between January 2007 and June 2019.
The majority (81%) of children have received systemic corticosteroids before starting tocilizumab. They started using tocilizumab mainly because they experienced persistent disease activity (98%), but also because of previous treatment intolerance (2%). The majority (82%) were treated together with other immunosuppressive agents at the time of tocilizumab initiation.
A quarter (25%) of children experience 33 SAEs. Compared with children who did not experience SAE, children with SAE were younger at the start of the disease (2.0 vs 3.9 years) and tocilizumab initiation (5.8 vs. 9.7 years).
Serious infection was the most common SAE (n = 15). The researchers also observed severe infusion reactions in 8 patients, all of whom stopped tokcizizab as a result. Again, children with infusion reactions were younger at the start of the disease (1.2 vs 3.6 years) and tocilizumab initiation (2.3 vs 9.4 years) compared with children who did not have infusion reactions.
Twenty-three of the 33 SAEs require hospitalization, and all SAEs require prolonged supervision. Surveillance for 8 patients with infusion reactions was only a few hours.
At the last follow-up, 43 children had stopped tocilizumab. The most common reasons for discontinuation were inefficiency (n = 19), followed by side effects (n = 13), remission (n = 5), both inefficiency and side effects (n = 3), and other reasons (n = 3). While no children died during tocilizumab treatment, 2 patients with undiagnosed systemic inflammatory disease died from uncontrolled disease 13 and 15 months after therapy was stopped.
“In practice, ongoing careful monitoring of patients treated with TCZ, especially young children and those with important systemic inflammation is needed,” the authors concluded.
Aeschlimann FA, Dumaine C, Wörner A, et al. Serious side effects in children with juvenile idiopathic rheumatism and other rheumatic diseases in tocilizumab – real world experience. Rheum Rheumatology Semin. 2020; 50 (4): 744-748. doi: 10.1016 / j.semarthrit.2020.05.013