Contributions
Abstract: EP1484
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS. The phase 4 Teri-PRO study (NCT01895335) examined efficacy, safety, tolerability, and satisfaction with teriflunomide treatment using patient-reported outcomes.
Objective: To report treatment satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM; version 1.4) up to Week 48 for all patients enrolled in Teri-PRO.
Methods: Teri-PRO is a global, prospective, single-arm, open-label study in patients with relapsing forms of MS receiving once-daily teriflunomide 7 mg (US patients only) or 14 mg for 48 weeks, administered according to local labelling, in the United States, Canada, Europe, and Chile, with a primary outcome measure of TSQM Global Satisfaction at Week 48. TSQM was measured at baseline (patients switching from prior disease-modifying therapy [DMT]), and at Week 4 and Week 48 or end of treatment (all patients).
Result: A total of 1000 patients were treated, of which 594 (59.4%) switched from another DMT within the previous 6 months, and 285 had not received a DMT in the previous 2 years. For the full study cohort, mean (standard deviation [SD]) age was 47.1 (11.0) years, mean (SD) time since first MS symptoms was 13.2 (9.5) years, and mean (SD) baseline Expanded Disability Status Scale score was 3.1 (2.0). A total of 786 (78.6%) of patients completed the study treatment period. Mean (SD) TSQM scores for teriflunomide were similar between Weeks 4 and 48 across all subscales: Global Satisfaction 72.3 (20.3)/68.2 (27.7); Side Effects 88.4 (19.2)/84.1 (24.8); Convenience 92.3 (12.2)/90.4 (14.7); Effectiveness 67.1 (20.0)/66.3 (24.7). In patients who switched to teriflunomide from another DMT within the prior 6 months, improvements were observed from baseline to Week 4 in each of the TSQM subscales, which were maintained at Week 48. Mean (SD) scores at baseline/Week 48 were: Global Satisfaction 53.4 (24.4)/69.7 (27.2); Side Effects 65.2 (32.1)/84.8 (24.4); Convenience 58.4 (23.4)/90.4 (15.1); Effectiveness 58.4 (22.4)/68.5 (23.7).
Conclusions: Results from the Teri-PRO study show that high levels of treatment satisfaction with teriflunomide are seen at Week 4 and maintained at Week 48 across all 4 TSQM domains. Patients switching to teriflunomide from other DMTs reported a sizeable increase in treatment satisfaction at Week 48 vs baseline.
Disclosure: Study supported by Sanofi Genzyme.
PKC: Consulting fees (AbbVie, Accordant, Acorda, Bayer, Biogen Idec, Genentech/Roche, Genzyme/Sanofi, Mallinckrodt, Novartis, Serono, Teva); research support (Actelion, Genentech/Roche, Novartis, NINDS, Opexa).
BK: Consulting fees (Bayer, Biogen Idec, Genzyme, Novartis, Pfizer, Questcor, Serono, Terumo, Teva); speakers bureaus (Bayer, Biogen Idec, Genzyme, Novartis, Pfizer, Questcor, Serono, Terumo, Teva).
KRE: Consulting fees (Biogen, Genzyme); speakers bureaus (Biogen, Genzyme, Novartis); research support (Actelion, Biogen, Eisai, Eli Lilly, Forum Pharmaceuticals, Genentech, Genzyme/Sanofi, Hoffmann-La Roche, Merz Pharmaceuticals, Novartis, Pfizer, Vaccinex).
SC: Employee of Sanofi Genzyme, with ownership interest.
PR: Employee of Sanofi Genzyme.
SB: Employee of Lincoln, mandated by Sanofi.
RG: Consulting fees (Bayer Schering, Biogen, Elan, Genzyme, Roche, Teva); grant/research support (Bayer Schering, Biogen, Genzyme, Teva).
Abstract: EP1484
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS. The phase 4 Teri-PRO study (NCT01895335) examined efficacy, safety, tolerability, and satisfaction with teriflunomide treatment using patient-reported outcomes.
Objective: To report treatment satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM; version 1.4) up to Week 48 for all patients enrolled in Teri-PRO.
Methods: Teri-PRO is a global, prospective, single-arm, open-label study in patients with relapsing forms of MS receiving once-daily teriflunomide 7 mg (US patients only) or 14 mg for 48 weeks, administered according to local labelling, in the United States, Canada, Europe, and Chile, with a primary outcome measure of TSQM Global Satisfaction at Week 48. TSQM was measured at baseline (patients switching from prior disease-modifying therapy [DMT]), and at Week 4 and Week 48 or end of treatment (all patients).
Result: A total of 1000 patients were treated, of which 594 (59.4%) switched from another DMT within the previous 6 months, and 285 had not received a DMT in the previous 2 years. For the full study cohort, mean (standard deviation [SD]) age was 47.1 (11.0) years, mean (SD) time since first MS symptoms was 13.2 (9.5) years, and mean (SD) baseline Expanded Disability Status Scale score was 3.1 (2.0). A total of 786 (78.6%) of patients completed the study treatment period. Mean (SD) TSQM scores for teriflunomide were similar between Weeks 4 and 48 across all subscales: Global Satisfaction 72.3 (20.3)/68.2 (27.7); Side Effects 88.4 (19.2)/84.1 (24.8); Convenience 92.3 (12.2)/90.4 (14.7); Effectiveness 67.1 (20.0)/66.3 (24.7). In patients who switched to teriflunomide from another DMT within the prior 6 months, improvements were observed from baseline to Week 4 in each of the TSQM subscales, which were maintained at Week 48. Mean (SD) scores at baseline/Week 48 were: Global Satisfaction 53.4 (24.4)/69.7 (27.2); Side Effects 65.2 (32.1)/84.8 (24.4); Convenience 58.4 (23.4)/90.4 (15.1); Effectiveness 58.4 (22.4)/68.5 (23.7).
Conclusions: Results from the Teri-PRO study show that high levels of treatment satisfaction with teriflunomide are seen at Week 4 and maintained at Week 48 across all 4 TSQM domains. Patients switching to teriflunomide from other DMTs reported a sizeable increase in treatment satisfaction at Week 48 vs baseline.
Disclosure: Study supported by Sanofi Genzyme.
PKC: Consulting fees (AbbVie, Accordant, Acorda, Bayer, Biogen Idec, Genentech/Roche, Genzyme/Sanofi, Mallinckrodt, Novartis, Serono, Teva); research support (Actelion, Genentech/Roche, Novartis, NINDS, Opexa).
BK: Consulting fees (Bayer, Biogen Idec, Genzyme, Novartis, Pfizer, Questcor, Serono, Terumo, Teva); speakers bureaus (Bayer, Biogen Idec, Genzyme, Novartis, Pfizer, Questcor, Serono, Terumo, Teva).
KRE: Consulting fees (Biogen, Genzyme); speakers bureaus (Biogen, Genzyme, Novartis); research support (Actelion, Biogen, Eisai, Eli Lilly, Forum Pharmaceuticals, Genentech, Genzyme/Sanofi, Hoffmann-La Roche, Merz Pharmaceuticals, Novartis, Pfizer, Vaccinex).
SC: Employee of Sanofi Genzyme, with ownership interest.
PR: Employee of Sanofi Genzyme.
SB: Employee of Lincoln, mandated by Sanofi.
RG: Consulting fees (Bayer Schering, Biogen, Elan, Genzyme, Roche, Teva); grant/research support (Bayer Schering, Biogen, Genzyme, Teva).