Zuiderbuur schreef op 26 juli 2017 10:45:
Twee fragmenten uit de conference call van Eli Lilly gisteren:
seekingalpha.com/article/4090428-eli-...“And then in terms of DBT and PE, yeah, there was one placebo-controlled trial in the RA study that showed an imbalance of DBT versus placebo. The overall rate, if you look at the multiple Phase 3 trial, in 3,000 patients, the overall rate of DBT on patients treated with baricitinib was the same as what is published in patients on the overall background rate in rheumatoid arthritis in general.”
“And Seamus, just to put a little bit of numbers on your prior question. To our knowledge the published rates of DBT and PE for patients with RA do range from approximately 0.3 to 0.8 per 100 patient years, and the rate reported for all RA patients receiving baricitinib during our development program was 0.46 per 100 patient years.”
In één van de studies met baricitinib werd dus een verhoogd aantal gevallen van DVT vastgesteld en daar maakt het FDA dus een probleem van, ook al is er gemiddeld over de verschillende studies geen toename vastgesteld.
Dat wordt dus iets om in het oog te houden.
In een fase IIb met ABT-494 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5132116/) dook ook al DVT en PE op.
"The percentage of patients with any treatment-emergent AE was numerically higher for ABT-494 than for placebo and increased in a dose-dependent manner with ABT-494 at 6, 12, and 18 mg (Table 3). However, the majority of reported AEs were considered mild to moderate in severity. The most commonly observed AEs were headache, nausea, upper respiratory tract infection, and urinary tract infection. The incidences of SAEs and severe AEs were low, without an apparent dose-response relationship (Table 3). Five patients treated with ABT-494 reported 7 SAEs (at 3 mg, 1 with pancreatitis and 1 with
pulmonary embolism; at 6 mg, 1 with
pulmonary embolism and
deep vein thrombosis and 1 with transient ischemic attack [TIA] and benign prostate hyperplasia; at 18 mg, 1 with acute respiratory failure). One patient receiving placebo experienced an SAE of bronchiectasis."