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Association between use of interferon beta and progression of disability in patients with relapsing-remitting
Afsaneh Shirani1, Yinshan Zhao, Mohammad Ehsanul Karim
1Division of Neurology and Brain Research Centre, Department of Medicine and Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, Canada.
Context:
Interferon beta is widely prescribed to treat multiple sclerosis (MS); however, its relationship with disability progression has yet to be established.
Objective:
To investigate the association between interferon beta exposure and disability progression in patients with relapsing-remitting MS.
Design, Setting, And Patients:
Retrospective cohort study based on prospectively collected data (1985-2008) from British Columbia, Canada. Patients with relapsing-remitting MS treated with interferon beta (n = 868) were compared with untreated contemporary (n = 829) and historical (n = 959) cohorts.
Main Outcome Measures:
The main outcome measure was time from interferon beta treatment eligibility (baseline) to a confirmed and sustained score of 6 (requiring a cane to walk 100 m; confirmed at >150 days with no measurable improvement) on the Expanded Disability Status Scale (EDSS) (range, 0-10, with higher scores indicating higher disability). A multivariable Cox regression model with interferon beta treatment included as a time-varying covariate was used to assess the hazard of disease progression associated with interferon beta treatment. Analyses also included propensity score adjustment to address confounding by indication.
Results:
The median active follow-up times (first to last EDSS measurement) were as follows: for the interferon beta-treated cohort, 5.1 years (interquartile range [IQR], 3.0-7.0 years); for the contemporary control cohort, 4.0 years (IQR, 2.1-6.4 years); and for the historical control cohort, 10.8 years (IQR, 6.3-14.7 years). The observed outcome rates for reaching a sustained EDSS score of 6 were 10.8%, 5.3%, and 23.1% in the 3 cohorts, respectively. After adjustment for potential baseline confounders (sex, age, disease duration, and EDSS score), exposure to interferon beta was not associated with a statistically significant difference in the hazard of reaching an EDSS score of 6 when either the contemporary control cohort (hazard ratio, 1.30; 95% CI, 0.92-1.83; P = .14) or the historical control cohort (hazard ratio, 0.77; 95% CI, 0.58-1.02; P = .07) were considered. Further adjustment for comorbidities and socioeconomic status, where possible, did not change interpretations, and propensity score adjustment did not substantially change the results.
Conclusion:
Among patients with relapsing-remitting MS, administration of interferon beta was not associated with a reduction in progression of disability.
Insights
Interferon beta treatment did not significantly alter disability progression in relapsing-remitting multiple sclerosis (MS) patients. This study found no evidence that interferon beta reduces the hazard of reaching a sustained Expanded Disability Status Scale score of 6.
Area of Science:
- Neurology
- Immunology
- Clinical Research
Background:
- Interferon beta is a common treatment for multiple sclerosis (MS).
- Its impact on the progression of disability in MS remains unclear.
Purpose of the Study:
- To examine the association between interferon beta treatment and disability progression in relapsing-remitting MS patients.
- To compare outcomes in treated patients versus contemporary and historical untreated cohorts.
Main Methods:
- Retrospective cohort study using prospectively collected data from British Columbia (1985-2008).
- Compared interferon beta-treated patients (n=868) with untreated contemporary (n=829) and historical (n=959) cohorts.
- Utilized Expanded Disability Status Scale (EDSS) to measure disability progression and Cox regression with propensity score adjustment.
Main Results:
- Interferon beta exposure showed no statistically significant difference in the hazard of reaching a sustained EDSS score of 6 compared to contemporary (HR 1.30, P=.14) or historical (HR 0.77, P=.07) controls.
- Observed outcome rates for reaching EDSS 6 were 10.8% (treated), 5.3% (contemporary), and 23.1% (historical).
- Adjustments for confounders and propensity scores did not alter these findings.
Conclusions:
- Interferon beta administration was not associated with a reduced rate of disability progression in patients with relapsing-remitting MS.
- The findings suggest that interferon beta may not be effective in slowing disability accumulation in this patient population.
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