Analysis of the safety profile of the TNF-alpha antibody infliximab based on the pooled data of 3 German post-marketing surveillance studies with 1,075 patients suffering from rhe…
JR Kalden, HP Tony, C Antoni, C Rauch · Zeitschrift für Gastroenterologie · 2004 · Heft 08
Bibliografische Angaben
Zusammenfassung
We planned to evaluate the safety profile of the TNF-alpha antagonist infliximab (IFX) in a large population of patients with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with IFX under routine conditions in the post-marketing phase. Therefore, we pooled the data of 3 independently performed post-marketing surveillance studies (PMSs, 2 studies with 309 and 107 CD patients, respectively, and 1 study with 659 RA patients), amounting to a total number of 1,075 patients treated at 255 study sites. All PMSs were designed as prospective non-experimental and non-controlled multicenter observational studies…