Contributions
Abstract: EP1645
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Aim: Describe the profiles of patients undergoing treatment with glatiramer acetate (GA) 40mg/ml in Spanish real-world clinical practice. This abstract shows the initial results of first year follow-up.
Methods: This is a prospective, observational, multicenter patient registry from 50 Spanish multiple sclerosis (MS) hospital units. Relapsing MS patients on GA 40 mg/ml treatment were recruited and will be followed for a maximum of 5 years. Patients' visits were performed as per daily clinical practice.
Results: At baseline 1331 patients were evaluated (892 females, median age 43 years). Mean age at diagnosis was 35.3 years and time from diagnosis to registry recruitment was 8.5 years. Majority of patients (n=994, 74.7%) had previously been treated with other immunomodulatory/ immunosuppressive drugs before entering the study. Prior therapies included GA 20 mg/ml(58.2%), interferons(34.0%) and other drugs(2.9%).Mean EDSS before starting GA 40 mg/ml was 1.9. The annualized relapse rate (ARR) was 0.4. Mean T1 Gd+ enhancing lesions was 0.9±5.1. Mean T2 new lesions were 2.0±4.9. 1056 patients(79.3%) completed visit 1.Mean time from baseline to visit 1 was 6.2 ± 2.1 months. Mean EDSS was 1.9 ±1.7.Majority of patients (n=973, 92.1%) showed no relapses since previous visit, 75 (7.1%) had 1, 5 had 2 and 1 had 3 relapses. Mean T1 Gd+ enhancing lesions was 0.4±1.7. Mean T2 new lesions were 1.0±2.7.813 patients (61.1%) completed visit 2.Mean time from baseline to visit 2 was 11.8±2.7 months and mean EDSS 2.0 ±1.7.The vast majority of patients (n=755, 92.9 %) showed no relapses since previous visit, 38 (4.7%) had 1 relapse, and 1 had 2 relapses.ARR in the first year of participation in the registry was 0.135.Mean T1 Gd+ enhancing lesions was 0.4±1.3.Mean T2 new lesions were 1.1±3.0.To date, mean time to follow up was 8.8 months.9.2% patients have discontinued the study; the main reason was end of treatment with GA 40mg/ml, mostly due to adverse events (42.6%) and lack of response (36.5%). 2 Severe Adverse Events, considered non-related to treatment, were reported in the annual pharmacovigilance report as per April 2017. Real World Data studies provide broader information on real-world safety, additional safety information will be reported in following communications.
Conclusion: Data from visits 1 and 2 from the 1331 patients included in the Spanish registry show that patients maintain low disease activity (low relapse rate, lesion load, and mild disability scores).
Disclosure: This research has been supported by TEVA Pharmaceuticals.
Abstract: EP1645
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Aim: Describe the profiles of patients undergoing treatment with glatiramer acetate (GA) 40mg/ml in Spanish real-world clinical practice. This abstract shows the initial results of first year follow-up.
Methods: This is a prospective, observational, multicenter patient registry from 50 Spanish multiple sclerosis (MS) hospital units. Relapsing MS patients on GA 40 mg/ml treatment were recruited and will be followed for a maximum of 5 years. Patients' visits were performed as per daily clinical practice.
Results: At baseline 1331 patients were evaluated (892 females, median age 43 years). Mean age at diagnosis was 35.3 years and time from diagnosis to registry recruitment was 8.5 years. Majority of patients (n=994, 74.7%) had previously been treated with other immunomodulatory/ immunosuppressive drugs before entering the study. Prior therapies included GA 20 mg/ml(58.2%), interferons(34.0%) and other drugs(2.9%).Mean EDSS before starting GA 40 mg/ml was 1.9. The annualized relapse rate (ARR) was 0.4. Mean T1 Gd+ enhancing lesions was 0.9±5.1. Mean T2 new lesions were 2.0±4.9. 1056 patients(79.3%) completed visit 1.Mean time from baseline to visit 1 was 6.2 ± 2.1 months. Mean EDSS was 1.9 ±1.7.Majority of patients (n=973, 92.1%) showed no relapses since previous visit, 75 (7.1%) had 1, 5 had 2 and 1 had 3 relapses. Mean T1 Gd+ enhancing lesions was 0.4±1.7. Mean T2 new lesions were 1.0±2.7.813 patients (61.1%) completed visit 2.Mean time from baseline to visit 2 was 11.8±2.7 months and mean EDSS 2.0 ±1.7.The vast majority of patients (n=755, 92.9 %) showed no relapses since previous visit, 38 (4.7%) had 1 relapse, and 1 had 2 relapses.ARR in the first year of participation in the registry was 0.135.Mean T1 Gd+ enhancing lesions was 0.4±1.3.Mean T2 new lesions were 1.1±3.0.To date, mean time to follow up was 8.8 months.9.2% patients have discontinued the study; the main reason was end of treatment with GA 40mg/ml, mostly due to adverse events (42.6%) and lack of response (36.5%). 2 Severe Adverse Events, considered non-related to treatment, were reported in the annual pharmacovigilance report as per April 2017. Real World Data studies provide broader information on real-world safety, additional safety information will be reported in following communications.
Conclusion: Data from visits 1 and 2 from the 1331 patients included in the Spanish registry show that patients maintain low disease activity (low relapse rate, lesion load, and mild disability scores).
Disclosure: This research has been supported by TEVA Pharmaceuticals.