The safety of Artlegia was evaluated in randomized, controlled clinical trials CREDO 1, CREDO 2, andCREDO 3. A total of 2444 patients with moderate to severe rheumatoid arthritis participated in the studies.
The immunogenicity potential of olokizumab according to the CREDO program is low and does not raise safety concerns
A total of 2304 patients received OKZ every 2 week or every 4week in combination with MTX.Theoverall exposure to olokizumab was 3625 patient-years with a mean treatment duration of1.6years (maximum 2.4). Exposure was 1839.5 PY withOKZ q2w and1785.8 PY withOKZ q4w regimen.