Contributions
Abstract: P1918
Type: Poster
Abstract Category: Late breaking news
Background: Previous studies suggest that multiple sclerosis (MS) patients have a greater risk of stroke than the general population. However, limited evidence exists regarding this risk following interferon treatment. We assessed the risk of stroke in MS patients treated with subcutaneous interferon β1-a (scIFNβ-1a) and its association with treatment duration using pooled data from clinical trials and post-marketing surveillance.
Methods: Seventeen Phase II-IV Merck KGaA sponsored trials of scIFNβ-1a were used to estimate the incidence rate (IR) and IR ratio (IRR) per 100 patient-years (PY), and associated 95% confidence intervals (CI), in patients treated with scIFNβ-1a (n=4412) and placebo (n=1055) for a total of 10,622 and 2005 PY, respectively. The association of time on treatment and stroke was assessed through a Cox model. IR, IRR, and hazard ratio (HR) were adjusted by age, sex, presence of comorbidities, and MS duration. Individual case safety reports were retrieved from the Global Patient Safety Database (1,594,414 PY through 22 May 2017) and reported rates per 100 PY were calculated as 100 times the number of cumulative events divided by PY of exposure to scIFNβ-1a.
Results: In 17 clinical trials, the IR/100 PY (95% CI) of stroke was 0.025 (0.004−0.150) in scIFNβ-1a (25 patients), and 0.051 (0.008−0.349) in placebo (11 patients). Compared with placebo, the IRR for scIFNβ-1a was 0.486 (0.238−0.995) and the HR 0.496 (0.235−1.043). Among scIFNβ-1a patients, the IRR in patients treated for < 2 years was 0.602 (0.159−2.277) and for ≥2 years 0.469 (0.196−1.124). Analysis of the safety database showed that among medically confirmed cases, the reported rate was 0.026/100 PY (420 events in 1,594,414 PY).
Conclusions: A trend towards decreased risk of stroke for scIFNβ-1a compared with placebo was observed in clinical trial data, with no significant increase or decrease in patients with short- (< 2 years) or long-term (≥2 years) exposure. Safety data from both clinical trial and post-marketing settings consistently suggest that treatment with scIFNβ-1a does not increase the risk of stroke in patients with MS.
Disclosure: Supported by Merck KGaA, Darmstadt, Germany
Conflicts of Interest:
MSE: is an employee of Merck KGaA, Darmstadt, Germany.
SV: is an employee of EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany.
JA: is an employee of EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany.
AG: is an employee of EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany.
Abstract: P1918
Type: Poster
Abstract Category: Late breaking news
Background: Previous studies suggest that multiple sclerosis (MS) patients have a greater risk of stroke than the general population. However, limited evidence exists regarding this risk following interferon treatment. We assessed the risk of stroke in MS patients treated with subcutaneous interferon β1-a (scIFNβ-1a) and its association with treatment duration using pooled data from clinical trials and post-marketing surveillance.
Methods: Seventeen Phase II-IV Merck KGaA sponsored trials of scIFNβ-1a were used to estimate the incidence rate (IR) and IR ratio (IRR) per 100 patient-years (PY), and associated 95% confidence intervals (CI), in patients treated with scIFNβ-1a (n=4412) and placebo (n=1055) for a total of 10,622 and 2005 PY, respectively. The association of time on treatment and stroke was assessed through a Cox model. IR, IRR, and hazard ratio (HR) were adjusted by age, sex, presence of comorbidities, and MS duration. Individual case safety reports were retrieved from the Global Patient Safety Database (1,594,414 PY through 22 May 2017) and reported rates per 100 PY were calculated as 100 times the number of cumulative events divided by PY of exposure to scIFNβ-1a.
Results: In 17 clinical trials, the IR/100 PY (95% CI) of stroke was 0.025 (0.004−0.150) in scIFNβ-1a (25 patients), and 0.051 (0.008−0.349) in placebo (11 patients). Compared with placebo, the IRR for scIFNβ-1a was 0.486 (0.238−0.995) and the HR 0.496 (0.235−1.043). Among scIFNβ-1a patients, the IRR in patients treated for < 2 years was 0.602 (0.159−2.277) and for ≥2 years 0.469 (0.196−1.124). Analysis of the safety database showed that among medically confirmed cases, the reported rate was 0.026/100 PY (420 events in 1,594,414 PY).
Conclusions: A trend towards decreased risk of stroke for scIFNβ-1a compared with placebo was observed in clinical trial data, with no significant increase or decrease in patients with short- (< 2 years) or long-term (≥2 years) exposure. Safety data from both clinical trial and post-marketing settings consistently suggest that treatment with scIFNβ-1a does not increase the risk of stroke in patients with MS.
Disclosure: Supported by Merck KGaA, Darmstadt, Germany
Conflicts of Interest:
MSE: is an employee of Merck KGaA, Darmstadt, Germany.
SV: is an employee of EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany.
JA: is an employee of EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany.
AG: is an employee of EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany.