Tuesday, 17 November 2015

Anti-Inflammation or Shrinking brain. The reason why you need longer studies

Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, Hayward B, Dangond F, Markovic-Plese S Immunological and short-term brain volume changes in relapsing forms of multiple sclerosistreated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial.
BACKGROUND:Brain volume atrophy is observed in relapsing-remitting multiple sclerosis (RRMS).
METHODS:Brain volume changes were evaluated in 23 patients with RRMS treated with interferon β-1a 44 μg given subcutaneously (SC) three times a week (tiw) and 15 healthy controls. Percentages of whole brain and tissue-specific volume change were measured from baseline (0 months) to 3 months, from 3 to 6 months, and from baseline to 6 months using SIENAX Multi Time Point (SX-MTP) algorithms. Immunological status of patients was also determined and correlations between subsets of T cells and changes in brain volume were assessed.
RESULTS: Interferon β-1a 44 μg SC tiw in 23 patients with RRMS resulted in significant reductions in whole brain and gray matter tissue volume early in the treatment course (baseline to 3 months; mean change; -0.95 %; P = 0.030, -1.52 %; P = 0.004, respectively), suggesting a short-term treatment-induced pseudoatrophy effect. From baseline to 6 months, there were significant correlations observed between decreased T- cell expression of IL-17 F and decreased whole brain and brain tissue-specific volume.
CONCLUSIONS: These findings are consistent with the interpretation of the pseudoatrophy effect as resolution of inflammation following treatment initiation with interferon β-1a 44 μg SC tiw, rather than disease-related tissue loss.

We explained this recently and why you need to rebaseline at a year. Until NEDA-4 came around where slowing brain atrophy was an added advantage over competitors drugs. It made it more interesting studying atrophy but this study is not long enough to show that the atrophy rate drops in the second year to show it is not just ineffective beta interferon.
Rebaseline at 24 months

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