Edward Fox1, Keith Edwards2, Gordon Burch3, Daniel R Wynn4, Chris LaGanke5, Heidi Crayton6, Samuel F Hunter7, Cynthia Huffman8, Edward Kim9, Linda Pestreich10, Kevin McCague11, Luigi Barbato12. 1. Central Texas Neurology Consultants, PA, 16040 Park Valley Drive, Building B, Suite 100, Round Rock, TX 78681, USA. Electronic address: foxtexms@gmail.com. 2. Multiple Sclerosis Center of Northeastern New York, NY, USA. Electronic address: kedwards@tristateneuro.com. 3. Blue Ridge Research Center, VA, USA. Electronic address: brresearch@aol.com. 4. Consultants in Neurology Multiple Sclerosis Center,IL, USA. Electronic address: dwynnmd@gmail.com. 5. North Central Neurology Associates, AL, USA. Electronic address: claganke@prn-inc.net. 6. Multiple Sclerosis Center of Greater Washington, VA, USA. Electronic address: msdoc1@hotmail.com. 7. Advanced Neurosciences Institute, TN, USA. Electronic address: sfhunter@neurosci.us. 8. Meridien Research, FL, USA. Electronic address: chuffman@meridienresearch.net. 9. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: edward.kim@novartis.com. 10. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: linda.pestreich@novartis.com. 11. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: kevin.mccague@novartis.com. 12. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: lou.barbato@novartis.com.
Abstract
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 receivediDMT. 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. CONCLUSION: Patients who switched from iDMT to fingolimod had significant improvements in most self-reported outcomes compared with those who continued iDMT.
RCT Entities:
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. CONCLUSION:Patients who switched from iDMT to fingolimod had significant improvements in most self-reported outcomes compared with those who continued iDMT.
Authors: Juan S Lasa; Pablo A Olivera; Stefanos Bonovas; Silvio Danese; Laurent Peyrin-Biroulet Journal: Drug Saf Date: 2021-03-05 Impact factor: 5.606
Authors: Diego Centonze; Roberta Fantozzi; Fabio Buttari; Luigi Maria Edoardo Grimaldi; Rocco Totaro; Francesco Corea; Maria Giovanna Marrosu; Paolo Confalonieri; Salvatore Cottone; Maria Trojano; Valentina Zipoli Journal: Front Neurol Date: 2021-04-22 Impact factor: 4.003