To predict long-term disability outcomes in TEMSO core (NCT00134563) and extension (NCT00803049) studies in patients with relapsing forms of MS treated with teriflunomide. Methods: A post hoc analysis was conducted in a subgroup of patients who received teriflunomide in the core study, had MRI and clinical relapse assessments at months 12 (n = 552) and 18, and entered the extension. Patients were allocated risk scores for disability worsening (DW) after 1 year of teriflunomide treatment: 0 = low risk; 1 = intermediate risk; and 2-3 = high risk, based on the occurrence of relapses (0 to ≥2) and/or active (new and enlarging) T 2 -weighted (T 2 w) lesions (≤3 or >3) after the 1-year MRI. Patients in the intermediate-risk group were reclassified as responders or nonresponders (low or high risk) according to relapses and T 2 w lesions on the 18-month MRI. Long-term risk (7 years) of DW was assessed by Kaplan-Meier survival curves. Results: In patients with a score of 2-3, the risk of 12-week-confirmed DW over 7 years was significantly higher vs those with a score of 0 (hazard ratio [HR] = 1.96, p = 0.0044). Patients reclassified as high risk at month 18 (18.6%) had a significantly higher risk of DW vs those in the low-risk group (81.4%; HR = 1.92; p = 0.0004). Conclusions: Over 80% of patients receiving teriflunomide were classified as low risk (responders) and had a significantly lower risk of DW than those at increased risk (nonresponders) over 7 years of follow-up in TEMSO. Close monitoring of relapses and active T 2 w lesions after short-term teriflunomide treatment predicts a differential rate of subsequent DW long term. ClinicalTrials.gov identifier: TEMSO, NCT00134563; TEMSO extension, NCT00803049.

Sormani, M.P., Truffinet, P., Thangavelu, K., Rufi, P., Simonson, C., & De Stefano, N. (2017). Predicting long-term disability outcomes in patients with MS treated with teriflunomide in TEMSO. NEUROLOGY® NEUROIMMUNOLOGY & NEUROINFLAMMATION, 4(5), 1-6 [10.1212/NXI.0000000000000379].

Predicting long-term disability outcomes in patients with MS treated with teriflunomide in TEMSO

De Stefano, Nicola
2017

Abstract

To predict long-term disability outcomes in TEMSO core (NCT00134563) and extension (NCT00803049) studies in patients with relapsing forms of MS treated with teriflunomide. Methods: A post hoc analysis was conducted in a subgroup of patients who received teriflunomide in the core study, had MRI and clinical relapse assessments at months 12 (n = 552) and 18, and entered the extension. Patients were allocated risk scores for disability worsening (DW) after 1 year of teriflunomide treatment: 0 = low risk; 1 = intermediate risk; and 2-3 = high risk, based on the occurrence of relapses (0 to ≥2) and/or active (new and enlarging) T 2 -weighted (T 2 w) lesions (≤3 or >3) after the 1-year MRI. Patients in the intermediate-risk group were reclassified as responders or nonresponders (low or high risk) according to relapses and T 2 w lesions on the 18-month MRI. Long-term risk (7 years) of DW was assessed by Kaplan-Meier survival curves. Results: In patients with a score of 2-3, the risk of 12-week-confirmed DW over 7 years was significantly higher vs those with a score of 0 (hazard ratio [HR] = 1.96, p = 0.0044). Patients reclassified as high risk at month 18 (18.6%) had a significantly higher risk of DW vs those in the low-risk group (81.4%; HR = 1.92; p = 0.0004). Conclusions: Over 80% of patients receiving teriflunomide were classified as low risk (responders) and had a significantly lower risk of DW than those at increased risk (nonresponders) over 7 years of follow-up in TEMSO. Close monitoring of relapses and active T 2 w lesions after short-term teriflunomide treatment predicts a differential rate of subsequent DW long term. ClinicalTrials.gov identifier: TEMSO, NCT00134563; TEMSO extension, NCT00803049.
Sormani, M.P., Truffinet, P., Thangavelu, K., Rufi, P., Simonson, C., & De Stefano, N. (2017). Predicting long-term disability outcomes in patients with MS treated with teriflunomide in TEMSO. NEUROLOGY® NEUROIMMUNOLOGY & NEUROINFLAMMATION, 4(5), 1-6 [10.1212/NXI.0000000000000379].
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11365/1038999