Natalizumab vs fingolimod study of efficacy with unknown safety: A story which ended at interval
RohitBhatia, Professor, All India Institute of Medical Sciences, New Delhi, India[email protected]
Inder Puri, Senior Resident, New Delhi, India
Submitted February 25, 2016
We read with great interest the study by Barbin et al. on the comparative effectiveness of fingolimod vs natalizumab, in which the authors concluded that natalizumab is superior (in relapse prevention only) to fingolimod. [1] However, we are concerned about the clinical applicability and novelty of this study.
Even though the authors showed concern about safety outcomes, they did not include safety outcome in the analysis. Also, a retrospective design has its inherent limitations of biases and excessive
missing data, which cannot be replaced by any statistical method.
With published observational studies, [2-4] network metanalysis, [5] and clinical experience, there is already a strong suggestion that natalizumab prevents disease relapses more efficiently than fingolimod. In clinical practice, more concern lies with composite efficacy outcomes in the form of disability prevention and the reduction, safety, and compliance of these drugs. In this study, [1] safety outcomes were not reported and disability prevention was not significantly different between the two
drugs. The research question about which second line agent should be preferred will remain unanswered until a controlled randomized trial is carried out with better outcome selections. Until then, a clinician must make this critical decision based on the available data from published, inconsistent
observational studies about efficacy and safety.
1. Barbin L, Rousseau C, Jousset N, et al. Comparative efficacy of fingolimodvsnatalizumab: A French multicenter observational study. Neurology Epub 2016 Jan 29.
2. Gajofatto A, Bianchi MR, Deotto L, Benedetti MD. Are natalizumab and fingolimod analogous second-line options for the treatment of relapsing-remitting multiple sclerosis? A clinical practice observational study. Eur Neurol 2014;72:173-80.
3. Carruthers RL, Rotstein DL, Healy BC, et al. An observational comparison of natalizumab vs. fingolimod using JCV serology to determine therapy. Mult Scler 2014;20:1381-1390.
4. Kalincik T, Horakova D, Spelman T, et al. Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. Ann Neurol 2015;77:425-435.
5. Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A. Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis. Eur J Clin Pharmacol 2012;68:441-448.
For disclosures, please contact the editorial office at [email protected].
We read with great interest the study by Barbin et al. on the comparative effectiveness of fingolimod vs natalizumab, in which the authors concluded that natalizumab is superior (in relapse prevention only) to fingolimod. [1] However, we are concerned about the clinical applicability and novelty of this study.
Even though the authors showed concern about safety outcomes, they did not include safety outcome in the analysis. Also, a retrospective design has its inherent limitations of biases and excessive missing data, which cannot be replaced by any statistical method.
With published observational studies, [2-4] network metanalysis, [5] and clinical experience, there is already a strong suggestion that natalizumab prevents disease relapses more efficiently than fingolimod. In clinical practice, more concern lies with composite efficacy outcomes in the form of disability prevention and the reduction, safety, and compliance of these drugs. In this study, [1] safety outcomes were not reported and disability prevention was not significantly different between the two drugs. The research question about which second line agent should be preferred will remain unanswered until a controlled randomized trial is carried out with better outcome selections. Until then, a clinician must make this critical decision based on the available data from published, inconsistent observational studies about efficacy and safety.
1. Barbin L, Rousseau C, Jousset N, et al. Comparative efficacy of fingolimodvsnatalizumab: A French multicenter observational study. Neurology Epub 2016 Jan 29.
2. Gajofatto A, Bianchi MR, Deotto L, Benedetti MD. Are natalizumab and fingolimod analogous second-line options for the treatment of relapsing-remitting multiple sclerosis? A clinical practice observational study. Eur Neurol 2014;72:173-80.
3. Carruthers RL, Rotstein DL, Healy BC, et al. An observational comparison of natalizumab vs. fingolimod using JCV serology to determine therapy. Mult Scler 2014;20:1381-1390.
4. Kalincik T, Horakova D, Spelman T, et al. Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. Ann Neurol 2015;77:425-435.
5. Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A. Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis. Eur J Clin Pharmacol 2012;68:441-448.
For disclosures, please contact the editorial office at [email protected].