How important is rebaseling when assessing NEDA rates? Essential - just look at the stunning ocrelizumab NEDA data. #ECTRIMS2016 #ResearchSpeak #MSBlog
"The poster below is another one of my ECTRIMS highlights. There is little doubt that ocrelizumab is a highly effective DMT. However, how does it perform if you treat-2-target of NEDA (T2T-NEDA)? I have been saying for sometime that to implement T2T-NEDA in clinical practice you have to rebaseline your metrics after the DMT in question has had time to work. For most maintenance DMTs this is 6 months."
"The analysis below shows that if you do this with ocrelizumab, then over 80% of subjects are NEDA from 6-24 months (figure 3). To the best of my knowledge this is the best NEDA data out there after rebaselining. I have yet to see the HSCT rebaseling NEDA rates, but I suspect they will be in the same ballpark. What is also important to highlight is the remarkable observation that 57% of the IFN-beta (Rebif) treated participants were also NEDA in this epoch. Based on earlier interferon data this is much better than one would expect. It looks as if from contemporary trials that the efficacy of Rebif has improved. Why? One reason could be that the population of trial participants have included subjects with more benign MS or Rebif has gotten better. I suspect both are correct. Most subjects in the Opera studies received RNF (Rebif new formulation). We know that RNF is associated with fewer NABs (neutralizing anti-bodies), which affect its efficacy; hence there are reasons to expect that Rebif's efficacy has improved. I am sure a lot of people will jump on the Rebif NEDA data to support its continued use as an effective DMT in the 'majority' of MSers."
"It will be interesting to see how the regulators, payers and/or healthcare commissioners respond to this data. I sincerely hope the regulators give ocrelizumab a liberal label that will allow first-line use in MSers with active disease. This will then allow HCPs and their patients to decide on which DMTs they want to use. However, as always in price-sensitive markets the payers and commissioner may have a different take on things particularly if ocrelizumab is priced at a premium."
Labels: ECTRIMS2016, NEDA, ocrelizumab, ResearchSpeak