Taltz Long Term Efficacy Study Red Flags

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 All who had received and responded were withdrawn from treatment within 12 week (lets use numbers not percentages) ALL relapsed.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


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That’s fairly bizarre though isn’t it? I know several people for whom Talz didn’t work or stopped working and they then moved on to something else, like a Jak Inhibitor etc. From what they say (although I’ve obviously not asked the question) other than it not working there wasn’t any other ‘adverse’ events. I couldn’t find in the article you shared what the adverse events were beyond the relapse ones?

I’ve been using Taltz now for 10 months and I am very happy with it. After the switch from 2 weekly to 4 weekly I did get a small flare. But stabilised quickly. I was using it in combination with leflunomide but had to stop that because of nerve damage in my toes. Now combining it with otezla

You raise some very good points @tntlamb and I am grateful that patient safety is at heart. I have not been involved in a study. (never been asked) But I would think that the mentioned study should fall under the watchful eye of rheumatologists. I would never engage in a study that involved “controls” instigated by the ones giving the study unless my rheumy was fully aware of what was expected and why.
My first line of defence is my rheumatologist…followed by the prescribed treatment plan. You asked what we would expect from a study:

  1. the goals and objectives (what do they hope to learn and why)
  2. the complete method to be used
  3. complete information post study ie age of people, what other meds and conditions did they have etc
    When I look at a study that has been done, my first question is, “Does this apply to me?
    Because I trust my rheumatologist, who has been involved in so much research and many studies, I would screen studies through his eyes.

Do you think the removal of Taltz at the end was an intended part of the study? Wow, that would have some ethical problems. “Let’s stop the med and see if the get worse!” Wow.