Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial
| Autor: | George C. Ebers, Anthony T. Reder, T.M. DeSimone, K. Beckmann, Gary Cutter, Douglas S. Goodin, Marcelo Kremenchutzky, Dawn Langdon, Volker Knappertz, Mark Rametta, Joel Oger |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization Kaplan-Meier Estimate Placebo law.invention Multiple Sclerosis Relapsing-Remitting Adjuvants Immunologic Randomized controlled trial law Cause of Death Internal medicine medicine Humans Age of Onset Survival analysis business.industry Hazard ratio Articles Interferon-beta Survival Analysis Confidence interval Surgery Cohort Female Neurology (clinical) business Interferon beta-1b Cohort study |
| DOI: | 10.1212/wnl.0b013e3182535cf6 |
| Popis: | Objective: To examine the effects of interferon beta (IFNβ)-1b on all-cause mortality over 21 years in the cohort of 372 patients who participated in the pivotal randomized clinical trial (RCT), retaining (in the analysis) the original randomized treatment-assignments. Methods: For this randomized long-term cohort study, the primary outcome, defined before data collection, was the comparison of all-cause mortality between the IFNβ-1b 250 μg and placebo groups from the time of randomization through the entire 21-year follow-up interval (intention-to-treat, log-rank test for Kaplan-Meier survival curves). All other survival outcomes were secondary. Results: After a median of 21.1 years from RCT enrollment, 98.4% (366 of 372) of patients were identified, and, of these, 81 deaths were recorded (22.1% [81 of 366]). Patients originally randomly assigned to IFNβ-1b 250 μg showed a significant reduction in all-cause mortality over the 21-year period compared with placebo ( p = 0.0173), with a hazard ratio of 0.532 (95% confidence interval 0.314–0.902). The hazard rate of death at long-term follow-up by Kaplan-Meier estimates was reduced by 46.8% among IFNβ-1b 250 μg–treated patients (46.0% among IFNβ-1b 50 μg–treated patients) compared with placebo. Baseline variables did not influence the observed treatment effect. Conclusions: There was a significant survival advantage in this cohort of patients receiving early IFNβ-1b treatment at either dose compared with placebo. Near-complete ascertainment, together with confirmatory findings from both active treatment groups, strengthens the evidence for an IFNβ-1b benefit on all-cause mortality. Classification of Evidence: This study provides Class III evidence that early treatment with IFNβ-1b is associated with prolonged survival in initially treatment-naive patients with relapsing-remitting multiple sclerosis. |
| Databáze: | OpenAIRE |
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