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. 2014 Feb 6;9(2):e88472.
doi: 10.1371/journal.pone.0088472. eCollection 2014.

Relapse rates in patients with multiple sclerosis switching from interferon to fingolimod or glatiramer acetate: a US claims database study

Niklas Bergvall  1 , Charles Makin  2 , Raquel Lahoz  1 , Neetu Agashivala  3 , Ashish Pradhan  3 , Gorana Capkun  1 , Allison A Petrilla  2 , Swapna U Karkare  2 , Catherine Balderston McGuiness  2 , Jonathan R Korn  2
Affiliations

Relapse rates in patients with multiple sclerosis switching from interferon to fingolimod or glatiramer acetate: a US claims database study

Niklas Bergvall et al. PLoS One. .

Abstract

Background: Approximately one-third of patients with multiple sclerosis (MS) are unresponsive to, or intolerant of, interferon (IFN) therapy, prompting a switch to other disease-modifying therapies. Clinical outcomes of switching therapy are unknown. This retrospective study assessed differences in relapse rates among patients with MS switching from IFN to fingolimod or glatiramer acetate (GA) in a real-world setting.

Methods: US administrative claims data from the PharMetrics Plus™ database were used to identify patients with MS who switched from IFN to fingolimod or GA between October 1, 2010 and March 31, 2012. Patients were matched 1∶1 using propensity scores within strata (number of pre-index relapses) on demographic (e.g. age and gender) and disease (e.g. timing of pre-index relapse, comorbidities and symptoms) characteristics. A claims-based algorithm was used to identify relapses while patients were persistent with therapy over 360 days post-switch. Differences in both the probability of experiencing a relapse and the annualized relapse rate (ARR) while persistent with therapy were assessed.

Results: The matched sample population contained 264 patients (n = 132 in each cohort). Before switching, 33.3% of patients in both cohorts had experienced at least one relapse. During the post-index persistence period, the proportion of patients with at least one relapse was lower in the fingolimod cohort (12.9%) than in the GA cohort (25.0%), and ARRs were lower with fingolimod (0.19) than with GA (0.51). Patients treated with fingolimod had a 59% lower probability of relapse (odds ratio, 0.41; 95% confidence interval [CI], 0.21-0.80; p = 0.0091) and 62% fewer relapses per year (rate ratio, 0.38; 95% CI, 0.21-0.68; p = 0.0013) compared with those treated with GA.

Conclusions: In a real-world setting, patients with MS who switched from IFNs to fingolimod were significantly less likely to experience relapses than those who switched to GA.

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Conflict of interest statement

Competing Interests: The authors have the following interests: The analyses for this study were funded by Novartis Pharma AG, the employer of NB, RL, NA, AP and GC. The following authors have a share in Novartis: NB, RL, NA, AP and GC. Fingolimod is a Novartis product. CM, AAP, SUK, CBM and JRK are employed by IMS Health. There are no further patents, products in development or marketed products to declare. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Figure 1
Figure 1. Attrition of the study sample, by reason.
Abbreviations: DMT, disease-modifying therapy; GA, glatiramer acetate; IFN, interferon; MS, multiple sclerosis; NDC, National Drug Code. aPatients were propensity-score matched within strata (number of pre-index relapses) on age, gender, region, health-plan type, prescribing physician specialty, Charlson comorbidity index score, pre-index use of dalfampridine, relapse within 90 days pre-index, pre-index total costs, symptoms (numbness, fatigue and bowel symptoms) and comorbidities (depression and diabetes mellitus).
Figure 2
Figure 2. Proportions of patients with at least one relapse during the post-index persistence period.
CI, confidence interval.
Figure 3
Figure 3. Time to relapse while persistent with therapy (Kaplan–Meier analysis).
Figure 4
Figure 4. Relapse rates during the post-index persistence period.
CI, confidence interval. Annualized relapse rates were based on generalized estimating equations regression using a negative binomial distribution.
See this image and copyright information in PMC

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