Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis

TNFα blockade in human diseases: An overview of efficacy and safety

“…In global clinical trial data released by Abbott pharmaceuticals in >10,000 RA patients, all of whom were screened for latent TB, the event rate of TB per 100 patient-years was 0.24 in longstanding RA (>3 years) and 0.11 per 100 patient-years in early RA [91]. In an analysis of the US postmarketing safety of ADA from Abbott-supported trials from 2002 to 2004 of prescreened patients with an estimated 55,384 patients years of exposure, 11 patients were reported to have TB, yielding a rate of 0.02 per 100 patient-years [91].…”

“…In an analysis of the US postmarketing safety of ADA from Abbott-supported trials from 2002 to 2004 of prescreened patients with an estimated 55,384 patients years of exposure, 11 patients were reported to have TB, yielding a rate of 0.02 per 100 patient-years [91]. Three of the eleven (27%) had extra-pulmonary TB.…”

“…Several reports have evaluated the risk of lymphoma in patients treated with TNFα blockers [91,98,99]. Standardized incidence ratio (SIR) values vary from 2.6 to 11.5 in anti-TNF-treated groups compared to the general population.…”

“…Other studies did not indicate an increased risk of CHF from TNFα antagonist use [91,104]. These studies have led to following recommendations regarding anti-TNF therapy: (a) RA patients with no history of CHF do not need a baseline echocardiogram to screen for heart failure; (b) patients with wellcompensated, mild CHF (NYHA classes I and II) should have a baseline echocardiogram done.…”

Les complications infectieuses liées à l’utilisation des anticorps monoclonaux chez l’homme

“…Les premières études réalisées après leur commercialisation entre 1998 et 2001 chiffraient le risque de tuberculose à 24,4 cas pour 100 000 patients traités par anti-TNFα, comparativement à 6,2 cas chez les patients qui n'avaient pas reçu d'anti-TNFα [26]. Cependant, une évolution semble se dessiner depuis le dépistage systématique des tuberculoses latentes avant la mise en route d'un traitement : la fréquence des tuberculoses apparaît beaucoup moins importante avec une réduction des cas rapportés à 0,02 à 0,16 cas pour 100 patients par an [27]. Par ailleurs, il semble que le risque soit similaire quelle que soit la molécule anti-TNFα utilisée [28].…”