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


CONCLUSIONS
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.
Novartis Pharma AG , Basel , Switzerland.
Niklas
N
Bergvall
Charles
C
Makin
Raquel
R
Lahoz
Neetu
N
Agashivala
Ashish
A
Pradhan
Gorana
G
Capkun
Allison
A
Petrilla
Swapna U
SU
Karkare
Catherine
C
Balderston McGuiness
Jonathan R
JR
Korn
D000328:Adult; D016208:Databases, Factual; D005260:Female; D000068876:Fingolimod Hydrochloride; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D066298:In Vitro Techniques; D007345:Insurance Claim Review; D007372:Interferons / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology; D010455:Peptides / Q000008:administration & dosage*; D011409:Propylene Glycols / Q000008:administration & dosage*; D012008:Recurrence; D012189:Retrospective Studies; D013110:Sphingosine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D014481:United States / Q000453:epidemiology
D007166:Immunosuppressive Agents; D010455:Peptides; D011409:Propylene Glycols; D000068717:Glatiramer Acetate; D007372:Interferons; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine