Tuesday, 30 September 2014

ClinicSpeak: switching from injectables to fingolimod

Satisfaction is high in those who switch from injectables to fingolimod: #ClinicSpeak #MSBlog #MSResearch

"This open-label study below shows that MSers switching from injectables therapies (IFNbeta and GA) do better on fingolimod a second-line DMT in most of Europe. This study mirrors our clinical experience with the drug. Are you surprised MSers do better when moving to an oral therapy that on average is more effective that the injectable therapies and is not associated with injection-site reactions or flu-like side effects? You also have to remember that the commonest reasons to switch therapies is breakthrough disease activity hence it is not surprising MSers do better on fingolimod. It is also reassuring that the side effect profile is no different to that seen in the pivotal phase 3 studies."
"There is data that has emerged from MSBase that if stay fail one so called 1st-line DMT and switch  to another 1st-line DMT you do worse on average than if you are escalated to more effective 2nd-line therapies, i.e. fingolimod or natalizumab. For this reason it is our practice to only let MSers have on trial of so called 1st-line or platform therapies. Please note these observations are average effects and individual MSers may do better than others on particular drugs. Unfortunately we still don't have any data to support stratification, so it remains a trial and error to select the most effective drug for the individual." 



Background: The Evaluate Patient OutComes (ClinicalTrials.gov Identifier: NCT01216072) study was conducted in North America to assess MSer- and physician-reported treatment satisfaction in MSers with relapsing multiple sclerosis (MS) who received oral fingolimod for 6 months after switching from an injectable disease-modifying therapy (iDMT), without an intervening washout.

Methods: In this open-label, multicenter study, MSers were randomized 3:1 to once-daily fingolimod 0.5 mg or iDMT. The primary study objective was to evaluate differences in satisfaction measured using the Treatment Satisfaction Questionnaire for Medication v1.4.

Results: Of 1053 MSers randomized, 790 MSers received fingolimod and 263 MSers received iDMT. Treatment satisfaction improved significantly in MSers who switched to fingolimod compared with those who continued iDMT. MSers also reported significant improvements in health-related quality of life, reduced depression, and reduced fatigue severity after a switch to fingolimod. No difference between the treatment groups was detected on the Patient Reported Indices for MS Activities scale. The safety profile of fingolimod was consistent with that reported in the pivotal phase 3 studies. The most commonly reported adverse events were more prevalent in MSers who switched to fingolimod than in those who continued iDMT (headache: 12% vs 3%; fatigue: 12% vs 6%). No significant relationship between lymphocyte counts and infection rates was observed and there was no evidence of additive immune-system effects, which might be expected when switching to a different class of immunomodulatory therapy with no intervening washout.

Conclusion: MSers who switched from iDMT to fingolimod had significant improvements in most self-reported outcomes compared with those who continued iDMT.

CoI: multiple

No comments:

Post a Comment

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.