Contributions
Abstract: EP1479
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Alemtuzumab is approved in Europe for the treatment of patients with active relapsing-remitting multiple sclerosis (RRMS) and is characterised as a high-efficacy agent along with natalizumab. According to the European Summary of Product Characteristics, natalizumab is indicated for the treatment of rapidly evolving severe (RES) RRMS (≥2 disabling relapses in 1 year with ≥1 gadolinium-enhancing lesion on brain MRI or a significant increase in T2 lesion load versus a recent MRI). In the absence of head-to-head trials, network meta-analyses were warranted to compare the high-efficacy agents in RES RRMS.
Goal: To compare efficacy outcomes of alemtuzumab 12 mg to natalizumab 300 mg in patients with RES RRMS via network meta-analysis.
Methods: A systematic literature search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and relevant conference proceedings was conducted to identify studies reporting the efficacy and safety of RRMS treatments up to September 2015. Randomised, controlled trials included in the analysis had ≥80% RRMS populations treated with disease-modifying treatments of interest and reported RES. The quality of each study was assessed using NICE guidelines. Random-effects Bayesian modelling was used for statistical analyses due to detected heterogeneity.
Results: Compared with natalizumab, alemtuzumab had numerically favourable effects on annualised relapse rate (ARR) (rate ratio = 0.71; 95% credible interval [Crl], 0.12 to 3.91), confirmed disability worsening (CDW) at 3 months (hazard ratio [HR] = 0.91; 95% Crl, 0.10 to 7.98), and CDW at 6 months (HR = 0.64; 95% Crl, 0.03 to 14.86), but no comparison reached statistical significance.
Conclusion: Based on indirect evidence, alemtuzumab showed numerically favourable effects on ARR, CDW at 3 months, and CDW at 6 months versus natalizumab. These did not reach statistical significance, with the wide 95% CrI for all comparisons indicating low precision associated with the limited data available on the outcomes of interest.
Disclosure:
Study support: Sanofi Genzyme.
JDG, RJDG, and FMC: Employees of Sanofi Genzyme.
KF and EW: Employees of Evidera.
Abstract: EP1479
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Alemtuzumab is approved in Europe for the treatment of patients with active relapsing-remitting multiple sclerosis (RRMS) and is characterised as a high-efficacy agent along with natalizumab. According to the European Summary of Product Characteristics, natalizumab is indicated for the treatment of rapidly evolving severe (RES) RRMS (≥2 disabling relapses in 1 year with ≥1 gadolinium-enhancing lesion on brain MRI or a significant increase in T2 lesion load versus a recent MRI). In the absence of head-to-head trials, network meta-analyses were warranted to compare the high-efficacy agents in RES RRMS.
Goal: To compare efficacy outcomes of alemtuzumab 12 mg to natalizumab 300 mg in patients with RES RRMS via network meta-analysis.
Methods: A systematic literature search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and relevant conference proceedings was conducted to identify studies reporting the efficacy and safety of RRMS treatments up to September 2015. Randomised, controlled trials included in the analysis had ≥80% RRMS populations treated with disease-modifying treatments of interest and reported RES. The quality of each study was assessed using NICE guidelines. Random-effects Bayesian modelling was used for statistical analyses due to detected heterogeneity.
Results: Compared with natalizumab, alemtuzumab had numerically favourable effects on annualised relapse rate (ARR) (rate ratio = 0.71; 95% credible interval [Crl], 0.12 to 3.91), confirmed disability worsening (CDW) at 3 months (hazard ratio [HR] = 0.91; 95% Crl, 0.10 to 7.98), and CDW at 6 months (HR = 0.64; 95% Crl, 0.03 to 14.86), but no comparison reached statistical significance.
Conclusion: Based on indirect evidence, alemtuzumab showed numerically favourable effects on ARR, CDW at 3 months, and CDW at 6 months versus natalizumab. These did not reach statistical significance, with the wide 95% CrI for all comparisons indicating low precision associated with the limited data available on the outcomes of interest.
Disclosure:
Study support: Sanofi Genzyme.
JDG, RJDG, and FMC: Employees of Sanofi Genzyme.
KF and EW: Employees of Evidera.