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Real-World Assessment of Disease-Modifying Drugs (CMSC 2016)
There is little information on the performance of disease-modifying drugs (DMDs) in the real world, according to Chris Kozma, an independent research consultant, Saint Helena Island, SC. Real world assessment of relapse rates of patients with MS comparing relapse rates between newer oral disease-modifying drugs (DMDs) and older self-injectable DMDs were presented in a poster presentation at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), held June 1-4 in National Harbor, MD.
The researchers conducted a retrospective analysis of the IMS Health Real Word Data Adjudicated Claims – US data to compare relapse rates of patients with MS newly initiating subcutaneous interferon β-1a (scIFNβ1a) with oral DMDs (fumarate, fingolimod, and teriflunomide). This database is an anonymous, HIPAA-compliant, national managed care database that represents approximately 70 million patient enrollees from over 65 health plans. There have been no previous real world studies on the effectiveness of oral DMDs. A total of 1665 patients (686 scIFNβ1a, 406 dimethyl fumarate, 455 fingolimod, and 118 teriflunomide) met the inclusion criteria. Relapse rates were measured 12 months after DMD initiations.
After controlling for patient demographics and clinical meaningful measures of disease severity, the researchers found that treatment-naïve patients with MS that were initiating scIFNβ1a had a lower likelihood of experiencing relapse in the first year compared with patients initiating fumarate or teriflunomide. Initiation of fumarate of teriflunomide was associated with a higher likelihood of relapse compared with scIFNβ1a. Additionally, patients with a relapse in the 90 days prior to DMD initiation were 2.3 more times as likely to have a relapse after DMD initiation.
The ICD-9 codes for MS do not distinguish between the different types of MS, i.e. relapse-remitting or primary progressive, which made it impossible for the researchers to differentiate by type of MS. Another limitation of the study was that the researchers could not be certain from the database data that the patients had not been treated with DMDs in the year prior to the study period, and that they could not control for whether the patients were newly diagnosed with MS.