maxen schreef op 19 april 2018 20:39:
[...]
Even de conclusie helemaal:
Resubmission Conclusions
Overall, the additional data provided in the resubmission did not substantially alter the efficacy
and safety data in the original submission. Thus, questions remain regarding the benefit/risk
assessment of baricitinib for RA patients.
Both the 2 and 4 mg doses of baricitinib demonstrated efficacy compared to placebo in RA
patients. Given the safety issues identified with baricitinib, whether there is additional benefit of
the 4 mg dose over the 2 mg dose is an issue we would like you to discuss at the AC meeting.
Baricitinib has several safety signals consistent with a potent immunosuppressive. Thrombosis
is a notable safety issue and we ask for you to discuss this safety issue and how that impacts the
benefit/risk profile of baricitinib. Since most of the safety data are with the 4 mg dose of
baricitinib and there are limited placebo control data, interpretation of the safety data is
challenging, particularly when events continue to accrue in patients treated with open-label
baricitinib. This raises the question of whether the 2 mg dose has a favorable benefit/risk profile;
however, an important issue is whether there is sufficient safety data to inform the benefit/risk
assessment of the baricitinib 2 mg dose. We ask for your input on all of these issues and look
forward to the discussion. De toegevoegde data van de resubmission voegen nauwelijks wat toe aan de effectiviteits- en veiligheidsdata van de eerste submission.
Voor 2mg eigenlijk te weinig safety data.
Het blijft daarom onduidelijk of 2mg beter (want:minder bijwerkingen) is dan 4mg (wellicht wat effectiever).
Te weinig placebo data. "Events" (lees: trombose-achtige problemen) blijven maar voorkomen bij patienten die via open-label baricitinib voorgeschreven krijgen.
Kortom: ziet er niet heel goed uit.