Safety evaluations of adalimumab for childhood chronic rheumatic diseases.
INTRODUCTION
Childhood rheumatic diseases (CRD) are chronic inflammatory conditions, often leading to severe functional impairment and disability. They produce high direct and indirect costs for patients, their families and society overall. Biologic treatment, adalimumab of note, has drastically changed the disease management, significantly decreasing morbidity, over childhood, and eventually lifelong. After 12 years of pediatric experience with adalimumab, safety data resulted of great interest.


AREAS COVERED
This review summarizes published knowledge about safety of adalimumab in clinical trials and real-life setting studies. Infections and site injection reactions are considered the most frequent adverse events, but the occurrence of second autoimmune diseases as well as malignancy development are the two major concerns of the medical community and families.


EXPERT OPINION
Adalimumab has revolutionized treatment and prognosis of most of CRD, resulting in good outcomes with highly acceptable safety profile. Number and type of entered adverse events differ from clinical trials and registries, these latter mirroring clinical real life. Different temporal observations and sample cohorts mainly account of this discrepancy. Both randomized clinical trials and real-world data are complementary. Clinical trials coupled with long-term registries will help to improve the evidence-based safety for children with CRD.
['Maccora|Ilaria|I|https://orcid.org/0000-0001-6418-3254', "dell'Anna|Maria Pia|MP|", 'Vannacci|Alfredo|A|', 'Simonini|Gabriele|G|']
D000068879:Adalimumab D000818:Animals D018501:Antirheumatic Agents D002648:Child D006801:Humans D000075662:Injection Site Reaction D016032:Randomized Controlled Trials as Topic D012042:Registries D012216:Rheumatic Diseases
safety Adalimumab pediatric adverse events registry children JIA TNFα anti-TNFα monoclonal antibody rheumatologic uveitis