Contributions
Abstract: P647
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS. The efficacy, safety, tolerability, and satisfaction with teriflunomide were investigated in a real-world clinical setting in the global, phase 4 Teri-PRO study (NCT01895335).
Objective: To evaluate patient-reported quality of life outcomes, measured by the Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire, up to Week 48 in the Teri-PRO study.
Methods: In this prospective, single-arm, open-label, phase 4 study, patients with relapsing forms of MS received once-daily teriflunomide 7 mg (US patients only) or 14 mg for 48 weeks, administered according to local labelling in the US, Canada, Europe, and Chile; the primary outcome measure was Global Satisfaction at Week 48, measured by the Treatment Satisfaction Questionnaire for Medication. Here we describe results from the MusiQoL Questionnaire, one of the key secondary outcomes of Teri-PRO.
Results: The efficacy population included 1000 patients, of which 594 switched from another disease-modifying therapy (DMT) within the previous 6 months, and 285 had not received a DMT in the previous 2 years. MusiQoL index total scores were comparable between baseline and Week 48: median (interquartile range [IQR]) scores at baseline (n=962) and Week 48 (n=850) were 68.1 (57.2, 78.9) and 70.3 (57.8, 81.3), respectively. Median (IQR) scores increased slightly from baseline to Week 48 in 3 of the 9 MusiQoL subscales (baseline/Week 48 scores: activities of daily living, 58.9 [37.5, 81.3]/62.5 [40.6, 84.4]; psychological well-being, 62.5 [43.8, 81.3]/68.8 [50.0, 87.5]; and relationships with friends, 58.3 [41.7, 75.0]/66.7 [41.7/75.0]); median (IQR) scores remained stable in the other 6 subscales (baseline/Week 48 scores: symptoms, 68.8 [50.0, 87.5]/68.8 [50.0, 87.5]; relationships with family, 75.0 [58.3/100.0]/75.0 [50.0, 100.0]; sentimental and sexual life, 62.5 [37.5, 75.0]/62.5 [37.5/75.0]; coping, 75.0 [50.0, 87.5]/75.0 [50.0, 100.0]; rejection, 100.0 [75.0, 100.0]/100.0 [75.0, 100.0]; and relationship with healthcare system, 83.3 [66.7/100.0]/83.3 [75.0, 100.0]).
Conclusions: Over 48 weeks, patients in the Teri-PRO study demonstrated stable or improved quality of life.
Disclosure: Study supported by Sanofi Genzyme.
RG: Consulting fees (Bayer Schering, Biogen, Elan, Genzyme, Roche, Teva); grant/research support (Bayer Schering, Biogen, Genzyme, Teva).
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.
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).
Abstract: P647
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS. The efficacy, safety, tolerability, and satisfaction with teriflunomide were investigated in a real-world clinical setting in the global, phase 4 Teri-PRO study (NCT01895335).
Objective: To evaluate patient-reported quality of life outcomes, measured by the Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire, up to Week 48 in the Teri-PRO study.
Methods: In this prospective, single-arm, open-label, phase 4 study, patients with relapsing forms of MS received once-daily teriflunomide 7 mg (US patients only) or 14 mg for 48 weeks, administered according to local labelling in the US, Canada, Europe, and Chile; the primary outcome measure was Global Satisfaction at Week 48, measured by the Treatment Satisfaction Questionnaire for Medication. Here we describe results from the MusiQoL Questionnaire, one of the key secondary outcomes of Teri-PRO.
Results: The efficacy population included 1000 patients, of which 594 switched from another disease-modifying therapy (DMT) within the previous 6 months, and 285 had not received a DMT in the previous 2 years. MusiQoL index total scores were comparable between baseline and Week 48: median (interquartile range [IQR]) scores at baseline (n=962) and Week 48 (n=850) were 68.1 (57.2, 78.9) and 70.3 (57.8, 81.3), respectively. Median (IQR) scores increased slightly from baseline to Week 48 in 3 of the 9 MusiQoL subscales (baseline/Week 48 scores: activities of daily living, 58.9 [37.5, 81.3]/62.5 [40.6, 84.4]; psychological well-being, 62.5 [43.8, 81.3]/68.8 [50.0, 87.5]; and relationships with friends, 58.3 [41.7, 75.0]/66.7 [41.7/75.0]); median (IQR) scores remained stable in the other 6 subscales (baseline/Week 48 scores: symptoms, 68.8 [50.0, 87.5]/68.8 [50.0, 87.5]; relationships with family, 75.0 [58.3/100.0]/75.0 [50.0, 100.0]; sentimental and sexual life, 62.5 [37.5, 75.0]/62.5 [37.5/75.0]; coping, 75.0 [50.0, 87.5]/75.0 [50.0, 100.0]; rejection, 100.0 [75.0, 100.0]/100.0 [75.0, 100.0]; and relationship with healthcare system, 83.3 [66.7/100.0]/83.3 [75.0, 100.0]).
Conclusions: Over 48 weeks, patients in the Teri-PRO study demonstrated stable or improved quality of life.
Disclosure: Study supported by Sanofi Genzyme.
RG: Consulting fees (Bayer Schering, Biogen, Elan, Genzyme, Roche, Teva); grant/research support (Bayer Schering, Biogen, Genzyme, Teva).
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.
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).