Contributions
Abstract: EP1605
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of MS. The Teri-CARE study will investigate quality of life (QoL) in patients with relapsing remitting MS (RRMS) treated with teriflunomide 14 mg in real-world clinical practice in Spain.
Objective: To describe the study design of Teri-CARE and report baseline patient characteristics for the full study population.
Methods: Teri-CARE is an ongoing prospective, observational, non-interventional study conducted at 48 hospitals in Spain. Eligible patients were 18-65 years of age, had RRMS, were treated with teriflunomide 14 mg for ≤4 weeks before enrolment, and had no relapse within 30 days before study entry. Clinic visits are expected to take place at baseline and every 6 months thereafter for up to 2 years. The primary endpoint is measuring the change in QoL over treatment time, measured using the Multiple Sclerosis Impact Scale-29 (MSIS-29). Secondary endpoints include measuring patient-reported outcomes (fatigue, depression, health-related productivity, urinary disorders, health resource utilisation, and treatment satisfaction), efficacy outcomes (annualised relapse rate, disability evaluation using the Expanded Disability Status Scale [EDSS], and MRI lesion analysis), treatment adherence, resource use, employment status, and safety.
Results: A total of 327 patients have been enrolled, 230 (70%) are female, with a mean age of 43.1 years (standard deviation [SD] = 10.4). The mean (SD) time since first diagnosis of MS is 7.1 (7.2) years and mean (SD) time since most recent relapse onset is 3.5 (4.3) years. The mean (SD)/median (range) baseline EDSS score is 1.7 (1.5)/1.5 (0 to 8.0). A total of 93 patients (28%) had T1 Gd+ lesions at baseline and 208 (64%) had received at least one prior disease modifying therapy.
Conclusions: Teri-CARE will provide valuable information on QoL outcomes in teriflunomide-treated patients with RRMS in the real-world setting in Spain.
Disclosure: GI: Received personal fees from Biogen, Novartis, Sanofi, Merck Serono and Teva, outside the submitted work. AO: Nothing disclosed. CC: Received speaking honoraria from Novartis, Sanofi and Biogen. IB: Nothing to disclose. JSF: No relevant disclosures related to this study. ALR: Received speaking honoraria from Biogen, Merck Serono, Sanofi-Genzyme, Novartis and Teva.
Study supported by Sanofi
Abstract: EP1605
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of MS. The Teri-CARE study will investigate quality of life (QoL) in patients with relapsing remitting MS (RRMS) treated with teriflunomide 14 mg in real-world clinical practice in Spain.
Objective: To describe the study design of Teri-CARE and report baseline patient characteristics for the full study population.
Methods: Teri-CARE is an ongoing prospective, observational, non-interventional study conducted at 48 hospitals in Spain. Eligible patients were 18-65 years of age, had RRMS, were treated with teriflunomide 14 mg for ≤4 weeks before enrolment, and had no relapse within 30 days before study entry. Clinic visits are expected to take place at baseline and every 6 months thereafter for up to 2 years. The primary endpoint is measuring the change in QoL over treatment time, measured using the Multiple Sclerosis Impact Scale-29 (MSIS-29). Secondary endpoints include measuring patient-reported outcomes (fatigue, depression, health-related productivity, urinary disorders, health resource utilisation, and treatment satisfaction), efficacy outcomes (annualised relapse rate, disability evaluation using the Expanded Disability Status Scale [EDSS], and MRI lesion analysis), treatment adherence, resource use, employment status, and safety.
Results: A total of 327 patients have been enrolled, 230 (70%) are female, with a mean age of 43.1 years (standard deviation [SD] = 10.4). The mean (SD) time since first diagnosis of MS is 7.1 (7.2) years and mean (SD) time since most recent relapse onset is 3.5 (4.3) years. The mean (SD)/median (range) baseline EDSS score is 1.7 (1.5)/1.5 (0 to 8.0). A total of 93 patients (28%) had T1 Gd+ lesions at baseline and 208 (64%) had received at least one prior disease modifying therapy.
Conclusions: Teri-CARE will provide valuable information on QoL outcomes in teriflunomide-treated patients with RRMS in the real-world setting in Spain.
Disclosure: GI: Received personal fees from Biogen, Novartis, Sanofi, Merck Serono and Teva, outside the submitted work. AO: Nothing disclosed. CC: Received speaking honoraria from Novartis, Sanofi and Biogen. IB: Nothing to disclose. JSF: No relevant disclosures related to this study. ALR: Received speaking honoraria from Biogen, Merck Serono, Sanofi-Genzyme, Novartis and Teva.
Study supported by Sanofi