October Quiz Flashcards
Normal lymphocyte counts ?
Above 1.2 nMols
Abnormal Lymphocyte Counts / Grades ?
Gr 1. 0.8. - 1.2 nMol
Gr 2. 0.5 - 0.8. nMol
Gr 3. 0.2 - 0.5 nMol
Gr 4. Below 0.2 nMol
Lymphopenia rates between oral DMTs in pivotal studies ?
1; 6-7; 16
What is the clinical course of these lymphopenias between Orals ?
The rates continue to rise with T & G whereas with Aub they are stable over time.
What were raised levels of some sub-groups of serious infections with Gilenya ?
HZ, bronch, Sin, Influenza, Tinea, PML
Tecfidera’s infection rates in Confirm ?
No different from placebo, although 2% points higher showed up in -
Naso, Upper Resp, Sinu, Bronchitis, Gastro,
Normal WBC count ?
4.0 - 11.0 nMol
Use with live vaccines ?
Not be used with Aubagio use or until 6 months discontinuation.
Do Aubagio patients consistently mount proper immune responses to vaccines ?
Yes, the three flu vaccines strains test on Aubagio patients showed adequate seroprotection, producing in all three tests seroprotection antibody titres above 70 % of the population at day 28. This was true also in testing with a neoantigen strain like rabies.
What is the flaw in using relative rates to placebo across drug trials?
The placebo group criteria may differ significantly between trials. Thus, there were differing background risk levels between trials that make comparisons invalid.
Longbrake monitored 221 DMF patients for lymphopenia. What were the key findings ?
17% of DMF patients acquired moderate to severe prolonged lymphopenia. A sub-group of this were 55 year olds and over, acquiring 40% in their age bracket.
Longbrake, 2015 discovered two other features around prolonged lymphopenia related to it changes and its role in efficacy
- Lymphopenia did not renormalise with continued use;
2. Level of lymphopenia had no relation to level of disease activity.
