MedicalResearch.com Interview with:
Fredrik Piehl MD PhD, prof. of Neurology
Neuroimmunology Unit. Dept Clinical Neuroscience
Karolinska University Hospital (Solna)
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In recent years we have seen a drastic increase in treatment options for relapsing-remitting multiple sclerosis (RRMS). However, it is difficult to deduce long term performance of different drugs based only on data from randomized controlled trials, since such trials are performed in selected patients without major co-morbidities and perhaps also enriched for those with a milder disease course. In addition, most trials only last for two years and lack relevant comparators. This lack of knowledge makes it difficult to predict if a drug will work or not for a given patient, in turn leading to frequent treatment switches but also different treatment practices across countries, regions or even between centers. This is also the case in Sweden, but with the additional aspect that some regions have opted to treat most newly diagnosed RRMS patients with rituximab (Rituxan/Mabthera), a drug not formally approved for RRMS, but with extensive safety data from other indications.
MedicalResearch.com: What should readers take away from your report?
Response: Given the large difference in how we treat newly diagnosed patients in counties of Stockholm and Västerbotten in Northern Sweden, we conducted a careful review of all patients starting with a multiple sclerosis drug for the first time 2012-October 2015.
Hence, we included an unselected, real world population-based patient sample with two different treatment approaches; one with a traditional escalation strategy where the multiple sclerosis drug to start with was selected as wisely as possible based on baseline characteristics, while in the other most patients started with rituximab. Looking at performance over time it was obvious that rituximab displayed the lowest rate of drug discontinuation overall, with superior clinical efficacy compared to traditional platform therapies, injectables and oral drugs, but also a trend for better efficacy than other highly effective options, e.g. natalizumab and fingolimod. Collectively, the findings suggest that rituximab to have better treatment outcomes in the short-medium term and also points to the importance to treat effectively from start.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In most cases RRMS requires continued treatment for years or even decades and we definitely need more information on long term efficacy and safety outcomes for all our newer multiple sclerosis drugs. An additional important aspect is also the patients´perspectives, which is very important for long term compliance. We know that some of our multiple sclerosis drugs are associated with frequent, but perhaps not dangerous side effects, such as flu-like symptoms from injectable interferons. Nevertheless this will have an important impact on the probability to continue treatment and therefore the chance to achieve treatment targets. The importance of quality of life issues has grown more important also for the pharma industry and we likely will see more data in this area in coming years. With the support of the US Patient centered outcomes research institute we were recently able to launch a nationwide prospective trial that aims to include several thousands of patients to be followed over several years where patient reported outcomes play a crucial role.
Disclosures: This study received funding only from public academic sources. I have previously received funding for academic studies from Biogen, Sanofi, Novartis, but no personal compensation.
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Granqvist M, Boremalm M, Poorghobad A, Svenningsson A, Salzer J, Frisell T, Piehl F. Comparative Effectiveness of Rituximab and Other Initial Treatment Choices for Multiple Sclerosis. JAMA Neurol. Published online January 08, 2018. doi:10.1001/jamaneurol.2017.4011
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