Some interesting numbers but lets look at the flow:
78 patients with plaque psoriasis. recieved Taltx treatment (160-mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52 Great RESULTS!
But the this group of patients went into the next phase and that’s where it gets interesting and make me question the ethics of the study. All who had received and responded were withdrawn from treatment within 12 week (lets use numbers not percentages) ALL relapsed. Treatment was restarted and of those 70, only 47 got back to where they were! But WAIT it gets worse during the withdrawal period 40 of those 70 patients experienced treatment-emergent adverse events and serious adverse events. That almost as bad as heroin. When re-treatment was started after the withdrawal 62 of of the 70 experienced treatment-emergent adverse events and serious adverse events.
One could make the conclusion that it is a safe effective medicine for treatment but withdrawal has some serious ramifications.
I’m not posting to discussTaltz in General but certainly am interested as are all of us are in your experiences with the med. I have heard some good things.
What I want to know is what in the sam hill was the independent testing lab Lilly using thinking and who approved such a study? Post marketing studies of any med are required, but I have never heard of creating such circumstances. was it for marketing advantage, poor study design, overthinking for the most complete data or what?
But my real concern here is patients. Its one thing to knowingly participate in a Post Market Study but just what did these patients know about what they were participating in. Would they have done so knowing the risks? I doubt it. I also doubt the study would have gone the way it did had the manufacturer gotten input from patients.
The Ben’s Friend’s Team has come across an organization that has been charged by a pharma company to do do just that. Talk to patients to make a PsA trial work for Patients. In the next week or so check your email for information about this opportunity. We vet these things pretty hard and require patients participating be compensated for their time. I feel this is one of the best things to have come down in a while - consider it. In the meantime I know we are all interested in what those who have had study experience have to say as well as what those who haven’t participated would expect if they did. PLEASE share