Contributions
Abstract: EP1737
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: Multiple sclerosis (MS) is the leading cause of neurological disability in young adults and affects approximately 2.5 million people worldwide. The prevalence of MS is 16-21 per 100,000 in Argentina and 14 per 100,000 in Chile. Previous studies have demonstrated the effectiveness of natalizumab in clinical trials and real-world settings. However, the effectiveness of natalizumab in relapsing-remitting (RRMS) patients from Argentina and Chile has not been studied.
Objective: To characterize the real-world effectiveness of natalizumab in patients with RRMS in Argentina and Chile.
Methods: A retrospective chart review was performed by neurologists at each site. Data were analysed for changes in annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score, the proportion of patients free from relapses, and disability worsening and improvement. Demographic and outcome variables were summarized. ARR was analysed using a repeated measure negative binomial regression model.
Results: Analyses included 117 patients. At baseline (BL), mean ARR was 1.97 (standard deviation [SD]: 1.21; 95% confidence interval [CI]: 1.75-2.20). ARR was significantly reduced at 1 year (mean: 0.06; SD: 0.24; 95% CI: 0.02-0.11) and 2 years (mean: 0.09; SD: 0.35; 95% CI: 0.02-0.16) of treatment. The proportion of patients (95% CI) free of relapses was significantly lower at 1 and 2 years than at baseline (BL: 7.69% (3.56-14.10); 1 year: 93.91% (87.86-97.52); 2 years: 92.93% (85.97-97.11). From BL, EDSS scores were reduced by a mean (95% CI) of 0.71 (0.46-0.96) at 1 year and 0.73 (0.43-1.03) at 2 years. The proportion of patients (95% CI) without disability worsening was 82.9% (74.8-89.2) at 1 year and 67.5% (58.2-75.9) at 2 years; the proportion with disability improvement was 44.4% at 1 year and 39.3% at 2 years. In the year prior to enrolment, 83 hospitalisations were recorded. During follow-up on treatment, recorded hospitalisations reduced significantly to 1 and 3 in follow up years 1 and 2 respectively (P< 0.01).
Conclusions: Consistent with previous clinical trials and real-world studies, natalizumab effectively reduced disease activity for patients with RRMS in Argentina and Chile as evidenced by decreased ARR and EDSS scores compared with baseline. Treatment with natalizumab also decreased the number of hospitalisations compared with the pre-treatment period.
Disclosure: Supported by Biogen.
CY: support from Merck Argentina, Bayer, Biogen, Genzyme, Novartis Argentina, Teva Argentina.
AC: support from Biogen.
VS: support from Bayer, Biogen, Genzyme, Merck Argentina, Novartis, Roche.
MRK: support from Biogen, Novartis, Roche.
JH: support from Biogen, Genzyme, Merck Argentina, Novartis.
LP, RP: support from Biogen, Genzyme, Merck Argentina, Novartis, Roche.
VDA: employee of Biogen
Abstract: EP1737
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: Multiple sclerosis (MS) is the leading cause of neurological disability in young adults and affects approximately 2.5 million people worldwide. The prevalence of MS is 16-21 per 100,000 in Argentina and 14 per 100,000 in Chile. Previous studies have demonstrated the effectiveness of natalizumab in clinical trials and real-world settings. However, the effectiveness of natalizumab in relapsing-remitting (RRMS) patients from Argentina and Chile has not been studied.
Objective: To characterize the real-world effectiveness of natalizumab in patients with RRMS in Argentina and Chile.
Methods: A retrospective chart review was performed by neurologists at each site. Data were analysed for changes in annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score, the proportion of patients free from relapses, and disability worsening and improvement. Demographic and outcome variables were summarized. ARR was analysed using a repeated measure negative binomial regression model.
Results: Analyses included 117 patients. At baseline (BL), mean ARR was 1.97 (standard deviation [SD]: 1.21; 95% confidence interval [CI]: 1.75-2.20). ARR was significantly reduced at 1 year (mean: 0.06; SD: 0.24; 95% CI: 0.02-0.11) and 2 years (mean: 0.09; SD: 0.35; 95% CI: 0.02-0.16) of treatment. The proportion of patients (95% CI) free of relapses was significantly lower at 1 and 2 years than at baseline (BL: 7.69% (3.56-14.10); 1 year: 93.91% (87.86-97.52); 2 years: 92.93% (85.97-97.11). From BL, EDSS scores were reduced by a mean (95% CI) of 0.71 (0.46-0.96) at 1 year and 0.73 (0.43-1.03) at 2 years. The proportion of patients (95% CI) without disability worsening was 82.9% (74.8-89.2) at 1 year and 67.5% (58.2-75.9) at 2 years; the proportion with disability improvement was 44.4% at 1 year and 39.3% at 2 years. In the year prior to enrolment, 83 hospitalisations were recorded. During follow-up on treatment, recorded hospitalisations reduced significantly to 1 and 3 in follow up years 1 and 2 respectively (P< 0.01).
Conclusions: Consistent with previous clinical trials and real-world studies, natalizumab effectively reduced disease activity for patients with RRMS in Argentina and Chile as evidenced by decreased ARR and EDSS scores compared with baseline. Treatment with natalizumab also decreased the number of hospitalisations compared with the pre-treatment period.
Disclosure: Supported by Biogen.
CY: support from Merck Argentina, Bayer, Biogen, Genzyme, Novartis Argentina, Teva Argentina.
AC: support from Biogen.
VS: support from Bayer, Biogen, Genzyme, Merck Argentina, Novartis, Roche.
MRK: support from Biogen, Novartis, Roche.
JH: support from Biogen, Genzyme, Merck Argentina, Novartis.
LP, RP: support from Biogen, Genzyme, Merck Argentina, Novartis, Roche.
VDA: employee of Biogen