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Abstract
Objective To compare the effectiveness of glatiramer acetate (GA) vs intramuscular interferon beta-1a (IFN-β-1a), we applied a previously published statistical method aimed at identifying patients' profiles associated with efficacy of treatments.
Methods Data from 2 independent multiple sclerosis datasets, a randomized study (the Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis [CombiRx] trial, evaluating GA vs IFN-β-1a) and an observational cohort extracted from MSBase, were used to build and validate a treatment response score, regressing annualized relapse rates (ARRs) on a set of baseline predictors.
Results The overall ARR ratio of GA to IFN-β-1a in the CombiRx trial was 0.72. The response score (made up of a linear combination of age, sex, relapses in the previous year, disease duration, and Expanded Disability Status Scale score) detected differential response of GA vs IFN-β-1a: in the trial, patients with the largest benefit from GA vs IFN-β-1a (lower score quartile) had an ARR ratio of 0.40 (95% confidence interval [CI] 0.25–0.63), those in the 2 middle quartiles of 0.90 (95% CI 0.61–1.34), and those in the upper quartile of 1.14 (95% CI 0.59–2.18) (heterogeneity p = 0.012); this result was validated on MSBase, with the corresponding ARR ratios of 0.58 (95% CI 0.46–0.72), 0.92 (95% CI 0.77–1.09,) and 1.29 (95% CI 0.97–1.71); heterogeneity p < 0.0001).
Conclusions We demonstrate the possibility of a criterion, based on patients' characteristics, to choose whether to treat with GA or IFN-β-1a. This result, replicated on an independent real-life cohort, may have implications for clinical decisions in everyday clinical practice.
Glossary
- ARR=
- annualized relapse rate;
- CombiRx=
- Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis;
- CI=
- confidence interval;
- EDSS=
- Expanded Disability Status Scale;
- GA=
- glatiramer acetate;
- Gd+=
- gadolinium-enhancing;
- IFN-β-1a=
- interferon beta-1a;
- MS=
- multiple sclerosis;
- NPDE=
- non-PDE;
- PDE=
- protocol-defined exacerbation;
- RCT=
- randomized clinical trial;
- RRMS=
- relapsing-remitting MS
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
- Received December 11, 2019.
- Accepted in final form August 24, 2020.
- © 2020 American Academy of Neurology
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