Objectives To report adverse events (AEs), which led to discontinuation of biologics agents, in a large cohort of patients with Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA).
Methods All patients, non responder or intolerant to DMARDs, treated with Biological Therapy (BT) at the Rheumatologic Centre of the G. Pini Institute (Milan, Italy) from 1999 to 2013 were taken into consideration.
Results 377 pts affected by JIA, 690 pts affected by RA, 221 pts affected by AS and 204 pts affected by PsA were enrolled in fourtheen years. A total of 220 (58.4%) JIA pts, 388 (56.2%) RA pts, 79 (35.7%) AS pts and 87 (42.6%) PsA pts failed to respond to or did not tolerate the BT. Infusion/injection reactions led to discontinuation in 47 (21.3%) JIA pts, 46 (11.8%) RA pts, 13 (16.4%) SA pts and 8 (9.1%) PsA pts. Cutaneous Diseases occurred in 15 (6.8%) JIA pts, 23 (5.9%) RA pts, 1 (1.2%) AS pt and 3 (3.4%) PsA pts. The adult population, unlike JIA population, frequently discontinued BT for infections and malignancy (infections: 27 (6.9%) RA pts, 7 (8.8%) AS pts and 6 (6.8%) PsA pts; Malignancy: 13 (3.3%) RA pts, 2 (2.5%) AS pts and 3 (3.4%) PsA). In JIA pts the most frequent AEs were: important behavioural alterations (depression, anxiety, aggressiveness), new onset of inflammatory bowel disease, in 10 (4.5%) JIA pts and new onset or flare-up of chronic iridocyclitis (in 17 (7.7%) JIA pts).
Conclusions In our 14-year experience, BT were well tolerated and safe; most of AEs reported were reversible by discontinuation of therapy. In the adult population the most significant causes of discontinuation were infections and malignancy, while in JIA pts were” important” behavioural alterations, new onset of inflammatory bowel disease and new onset or flare-up of chronic iridocyclitis. The percentage of failure to response was the greatest similarity between the two populations.
Disclosure of Interest : None declared