Contributions
Abstract: P706
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Natalizumab (NTZ) may cause progressive multifocal leukoencephalopathy (PML) in patients with detected anti-JCV-antibody after extended use. Prior use of immunosuppressive agents further increases risk of PML. There are no guidelines for switching from NTZ to another disease modifying therapy (DMT). Significant reactivation of the patient"s MS disease activity may occur after NTZ withdrawal.
Objectives: To determine if teriflunomide is safe and effective in patients switching from NTZ to teriflunomide.
Methods: Twenty-five consecutive RMS patients, ages 28 to 60, who had received 12 or more NTZ treatments and who were anti-JCV antibody detected, were switched to teriflunomide and were analyzed using retrospective data collection. Teriflunomide treatment was started as soon as medication was available upon stopping NTZ. Prior use of an immunosuppressant was recorded. Clinical status was measured by tolerance and safety, clinical relapses and EDSS at 6 and 12 months. MRI findings were analyzed.
Results: Mean age was 48 (SD 12); 80% were female. Mean number of NTZ treatments was 39 (SD 12). Mean months of teriflunomide treatment was 20 (SD 11). Nine patients had prior immunosuppression (36%) with a mean treatment duration with NTZ of 48 months (SD 11). Mean time between last NTZ dose and first teriflunomide dose was 6 weeks (SD 4). Mean EDSS at baseline was 3.5 (SD 1.5). After 6 months, the mean EDSS of remaining 23 patients was 3.3 (SD 1.5) and there were no clinical exacerbations. Two of the 25 patients discontinued due to gastrointestinal issues in the first few weeks of treatment. Five patients (20%) had temporary hair thinning with full recovery. There were no laboratory abnormalities. Between 6 and 12 months, four patients had mild exacerbations and switched to other therapies. There were no serious exacerbations (greater than 1 EDSS score). Of the 23 patients who had MRIs performed at 12 months, 21 patients had stable MRIs. One patient had new T2 lesions and one other patient had Gd+ lesions. No cases of PML occurred.
Discussion: There is a need for a DMT for patients who are discontinuing NTZ due to risk of PML. Teriflunomide may be a safe and effective therapy for transition from NTZ. A shortened "washout" interval appears to be effective with a low relapse rate.
Disclosure: Sponsored by an unrestricted educational grant from Genzyme, A Sanofi Company
Keith R. Edwards: Consulting and/or Speaking fees: Biogen, Genzyme; EMD Serono; Grant/Research support: Biogen, Eisai, Eli Lilly, Genentech, Genzyme/Sanofi, Hoffmann-La Roche, Merz Pharmaceuticals, Novartis
JS: nothing to disclose
JO: nothing to disclose
Abstract: P706
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Natalizumab (NTZ) may cause progressive multifocal leukoencephalopathy (PML) in patients with detected anti-JCV-antibody after extended use. Prior use of immunosuppressive agents further increases risk of PML. There are no guidelines for switching from NTZ to another disease modifying therapy (DMT). Significant reactivation of the patient"s MS disease activity may occur after NTZ withdrawal.
Objectives: To determine if teriflunomide is safe and effective in patients switching from NTZ to teriflunomide.
Methods: Twenty-five consecutive RMS patients, ages 28 to 60, who had received 12 or more NTZ treatments and who were anti-JCV antibody detected, were switched to teriflunomide and were analyzed using retrospective data collection. Teriflunomide treatment was started as soon as medication was available upon stopping NTZ. Prior use of an immunosuppressant was recorded. Clinical status was measured by tolerance and safety, clinical relapses and EDSS at 6 and 12 months. MRI findings were analyzed.
Results: Mean age was 48 (SD 12); 80% were female. Mean number of NTZ treatments was 39 (SD 12). Mean months of teriflunomide treatment was 20 (SD 11). Nine patients had prior immunosuppression (36%) with a mean treatment duration with NTZ of 48 months (SD 11). Mean time between last NTZ dose and first teriflunomide dose was 6 weeks (SD 4). Mean EDSS at baseline was 3.5 (SD 1.5). After 6 months, the mean EDSS of remaining 23 patients was 3.3 (SD 1.5) and there were no clinical exacerbations. Two of the 25 patients discontinued due to gastrointestinal issues in the first few weeks of treatment. Five patients (20%) had temporary hair thinning with full recovery. There were no laboratory abnormalities. Between 6 and 12 months, four patients had mild exacerbations and switched to other therapies. There were no serious exacerbations (greater than 1 EDSS score). Of the 23 patients who had MRIs performed at 12 months, 21 patients had stable MRIs. One patient had new T2 lesions and one other patient had Gd+ lesions. No cases of PML occurred.
Discussion: There is a need for a DMT for patients who are discontinuing NTZ due to risk of PML. Teriflunomide may be a safe and effective therapy for transition from NTZ. A shortened "washout" interval appears to be effective with a low relapse rate.
Disclosure: Sponsored by an unrestricted educational grant from Genzyme, A Sanofi Company
Keith R. Edwards: Consulting and/or Speaking fees: Biogen, Genzyme; EMD Serono; Grant/Research support: Biogen, Eisai, Eli Lilly, Genentech, Genzyme/Sanofi, Hoffmann-La Roche, Merz Pharmaceuticals, Novartis
JS: nothing to disclose
JO: nothing to disclose