Multiple sclerosis hospitalizations among users of oral disease-modifying therapies.
BACKGROUND
Oral disease-modifying therapies, namely dimethyl fumarate, fingolimod and teriflunomide, have become standard treatments for multiple sclerosis. Clinical trials demonstrated a reduction in annual relapse rate, but real-world data is lacking, particularly in older adults. The objective of our study is to evaluate the real-world effectiveness of oral disease-modifying therapies among individuals with multiple sclerosis.


METHODS
We used OptumTM ClinformaticsTM Data Mart, a large dataset representative of commercially insured individuals in the United States, to conduct a retrospective cohort study of adult users of three oral disease-modifying therapies from September 2010 through September 2015. The therapies of interest included dimethyl fumarate, teriflunomide, and fingolimod. Hospitalization for multiple sclerosis, an approximation of the clinical trial endpoint for relapse, was the study outcome. Cox proportional hazards models were built to evaluate the association of demographic and clinical factors with multiple sclerosis hospitalization. A subgroup analysis was performed on individuals ages 55 years or older.


RESULTS
We identified 1,823, 318, and 1,156 users of dimethyl fumarate, teriflunomide, and fingolimod that met our inclusion criteria, respectively. Rates of hospitalizations for multiple sclerosis were low among these 3,297 persons (1,041 ages 55+): 36/1,000 patient-years for dimethyl fumarate, 43/1,000 for teriflunomide, and 45/1,000 for fingolimod. Multiple sclerosis hospitalization was associated with therapy switching (adjusted hazard ratio 2.21, 95% confidence interval 1.57-2.84), minority (1.44, 1.10-1.89), and history of relapse in the year preceding oral therapy initiation (5.25, 3.89-7.09).


CONCLUSION
Oral disease-modifying therapies are comparably effective for the outcome of multiple sclerosis hospitalization, even in older adults.
['Pham Nguyen|Thanh Phuong|TP|', 'Jacobs|Dina|D|', 'Thibault|Dylan|D|', 'Willis|Allison W|AW|']
D000368:Aged D003437:Crotonates D000069462:Dimethyl Fumarate D000068876:Fingolimod Hydrochloride D006760:Hospitalization D006801:Humans D007166:Immunosuppressive Agents D008875:Middle Aged D009103:Multiple Sclerosis D020529:Multiple Sclerosis, Relapsing-Remitting D012189:Retrospective Studies D014052:Toluidines D014481:United States
Multiple sclerosis Dimethyl fumarate Teriflunomide Demyelinating autoimmune disease Fingolimod hydrochloride Pharmacoepidemiology