Outcomes of switching directly to oral fingolimod from injectable therapies: Results of the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis.
BACKGROUND
The Evaluate Patient OutComes (ClinicalTrials.gov Identifier: NCT01216072) study was conducted in North America to assess patient- and physician-reported treatment satisfaction in patients with relapsing multiple sclerosis (MS) who received oral fingolimod for 6 months after switching from an injectable disease-modifying therapy (iDMT), without an intervening washout.


METHODS
In this open-label, multicenter study, patients were randomized 3:1 to once-daily fingolimod 0.5mg or iDMT. The primary study objective was to evaluate differences in satisfaction measured using the Treatment Satisfaction Questionnaire for Medication v1.4.


RESULTS
Of 1053 patients randomized, 790 patients received fingolimod and 263 patients received iDMT. Treatment satisfaction improved significantly in patients who switched to fingolimod compared with those who continued iDMT. Patients also reported significant improvements in health-related quality of life, reduced depression, and reduced fatigue severity after a switch to fingolimod. No difference between the treatment groups was detected on the Patient Reported Indices for MS Activities scale. The safety profile of fingolimod was consistent with that reported in the pivotal phase 3 studies. The most commonly reported adverse events were more prevalent in patients who switched to fingolimod than in those who continued iDMT (headache: 12% vs 3%; fatigue: 12% vs 6%). No significant relationship between lymphocyte counts and infection rates was observed and there was no evidence of additive immune-system effects, which might be expected when switching to a different class of immunomodulatory therapy with no intervening washout.


CONCLUSIONS
Patients who switched from iDMT to fingolimod had significant improvements in most self-reported outcomes compared with those who continued iDMT.
Central Texas Neurology Consultants, PA, 16040 Park Valley Drive, Building B, Suite 100, Round Rock, TX 78681, USA. Electronic address: foxtexms@gmail.com.
Edward
E
Fox
Multiple Sclerosis Center of Northeastern New York, NY, USA. Electronic address: kedwards@tristateneuro.com.
Keith
K
Edwards
Blue Ridge Research Center, VA, USA. Electronic address: brresearch@aol.com.
Gordon
G
Burch
Consultants in Neurology Multiple Sclerosis Center,IL, USA. Electronic address: dwynnmd@gmail.com.
Daniel R
DR
Wynn
North Central Neurology Associates, AL, USA. Electronic address: claganke@prn-inc.net.
Chris
C
LaGanke
Multiple Sclerosis Center of Greater Washington, VA, USA. Electronic address: msdoc1@hotmail.com.
Heidi
H
Crayton
Advanced Neurosciences Institute, TN, USA. Electronic address: sfhunter@neurosci.us.
Samuel F
SF
Hunter
Meridien Research, FL, USA. Electronic address: chuffman@meridienresearch.net.
Cynthia
C
Huffman
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: edward.kim@novartis.com.
Edward
E
Kim
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: linda.pestreich@novartis.com.
Linda
L
Pestreich
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: kevin.mccague@novartis.com.
Kevin
K
McCague
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: lou.barbato@novartis.com.
Luigi
L
Barbato
D000284:Administration, Oral; D002170:Canada; D057915:Drug Substitution / Q000379:methods*; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States
D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
Depression; Fatigue; Fingolimod; Multiple sclerosis; Satisfaction