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Can anyone at Biogen tell me any adverse events

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Anonymous said:
No one would know that information. Even the Dr's and patients participating in the trial are blinded from who receives placebo or active drug.
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I believe you mean we wouldn't know which patient (active drug or placebo) but those who tabulate the data would know about adverse effects that were taking place.
 








Anonymous said:
they asked for AE's assoc w/ daclizamab, not placebo. And even if someone is tabulating data, they don't report it.
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We may be splitting hairs here but during any drug trial, the clinicians report any kind of effects to the company conducting the trial. Of course they don't know if the effect comes from a patient on the drug or one taking the placebo. All effects are tabulated and you are right in that until the trial is completed, the data is not reported. An exception to that general protocol rule would be if there were severe adverse effects. That situation would likely stop the trial immediately.

So to answer the first poster's question, while adverse effects may be known at this time, they certainly would not be made public.
 




There is only data from the Phase II study entitled CHOICE at this time. Here is the summary including preliminary safety data:

The CHOICE trial is evaluated the efficacy and safety of daclizumab or placebo added to interferon beta therapy in 230 patients with active MS who were enrolled at study centers in the U.S. and Europe. Patients were randomized to receive daclizumab 2 mg/kg every two weeks, daclizumab 1 mg/kg every four weeks, or placebo added to ongoing interferon beta treatment.

The primary efficacy analysis showed that at 24 weeks, the 75 patients in the 2 mg/kg group experienced 72% fewer new or enlarged Gd+ on average compared to the 77 patients who received a placebo (p=0.004). The 78 patients in the 1 mg/kg group experienced a 25% reduction in new or enlarged lesions compared with placebo but that measurement did not achieve statistical significance.

Based on data up to week 24, analysis of the relapse rate, which was a secondary endpoint, indicates that both daclizumab regimens revealed a trend in reducing the annualized relapse rate compared to placebo (an approximately 35% reduction), but these observations did not reach statistical significance.

Preliminary safety data showed similar rates of infection across all treatment groups with an overall greater incidence of serious infections in the daclizumab treated groups. (4.6% versus 1.3% placebo). Urinary tract infections were slightly higher with the 2 mg/kg dose (17% vs 13% placebo). The incidence of cutaneous events was higher in the combined daclizumab groups (34% daclizumab vs. 27% placebo) but was mild to moderate and most resolved with little or no treatment.
 








does it really matter??? Can't imagine anything worse than PML and yet the drug still is commercially available. Biogen has deep pockets and that always wins in todays world.
 








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