Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis

Abstract

Objective:

Disease-modifying therapies, such as fingolimod, interferon (IFN) and glatiramer acetate (GA), have differing effects on relapse rates in patients with multiple sclerosis (MS), but little is known about the real-world differences in relapse rates with these treatments. This retrospective study assessed relapse rates in patients with active MS initiating fingolimod, IFN or GA therapy in a real-world setting.

Methods:

Using administrative claims data from the US PharMetrics Plus database, we identified previously treated and untreated patients with MS who initiated fingolimod, IFN or GA treatment between 1 October 2010 and 31 March 2011 and had experienced a relapse in the previous year. A claims-based algorithm was used to identify relapses over the persistence period in patients with 540 days of post-index continuous enrolment. A logistic regression model assessed the probability of having at least one relapse and a generalized linear model estimated differences in annualized relapse rates (ARRs).

Results:

The study enrolled 525 patients (fingolimod, n = 128; combined IFN/GA cohort, n = 397) of the 31,041 initially identified. Similar findings for fingolimod and IFN/GA were observed for the unadjusted proportion of patients experiencing relapses (31.3% vs. 34.0%, respectively; p = 0.5653) and ARRs (0.50 vs. 0.55, respectively) while persistent to treatment. After adjusting for baseline differences, fingolimod was associated with a 52% reduction in the probability of having a relapse (odds ratio, 0.48; 95% confidence interval [CI], 0.28–0.84; p = 0.0097) and a 50% reduction in ARR (rate ratio, 0.50; 95% CI, 0.34–0.75; p = 0.0006) compared with IFN/GA.

Limitations:

Identification of relapses is based on the claims in the database rather than on a clinical assessment.

Conclusions:

In a real-world setting, fingolimod was shown to be associated with significantly lower relapse rates than IFN/GA in patients with MS who had a history of relapses.

Keywords::

• Disease-modifying therapies
• Fingolimod
• Glatiramer acetate
• Interferon
• Multiple sclerosis
• Relapse

Transparency

Declaration of funding

This study was funded by Novartis Pharma AG, Basel, Switzerland.

Declaration of financial/other relationships

N.B., R.L. and G.C. are paid employees of Novartis Pharma AG, Basel, Switzerland. N.A. and A.P. are paid employees of Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. J.R.K., A.P., S.U.K., C.B.M. and C.M. are paid employees of IMS Health, Plymouth Meeting, PA, USA.

CMRO peer reviewers on this manuscript have received an honorarium for their review work, but have no other relevant financial or other relationships to disclose.

Acknowledgements

The authors take full responsibility for the content of the paper. The authors thank Drs Gemma Carter and Adam Giles (Oxford PharmaGenesis™ Ltd) for medical writing support, editorial assistance, and collation and incorporation of comments from all authors.

Notes

*Gilenya is a registered trademark of Novartis Pharma AG, Switzerland

†Avonex is a registered trademark of Biogen Idec, Cambridge, MA, USA

‡Rebif is a registered trademark of Merck Serono SA, Genf, Switzerland

§Extavia is a registered trademark of Novartis Pharma AG, Switzerland

¶Betaseron is a registered trademark of Bayer Healthcare, Germany

⊥Copaxone is a registered trademark of Teva Pharmaceuticals, Israel