CNS drugs · 2018
Oral Disease-Modifying Treatments for Relapsing Multiple Sclerosis: A Likelihood to Achieve No Evidence of Disease Activity or Harm Analysis.
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Papadopoulos Dimitrios, Mitsikostas Dimos-Dimitrios D
Аннотация
BACKGROUND: The likelihood to help or harm (LHH) is an absolute measure of the benefit versus risk profile of a medication, which can be used to assess the potential for benefit versus harm of different disease-modifying treatments (DMTs) for relapsing multiple sclerosis (R-MS) and facilitate clinical decision-making.
OBJECTIVE: The objective of this study was to assess absolute differences in benefit:risk ratios of oral DMTs for R-MS, using LHH analysis with no evidence of disease activity (NEDA) as beneficial outcome.
DESIGN/METHODS: The number needed to treat for a paient to achieve NEDA (NNTBNEDA) was used as an effect size metric of efficacy and the number needed to treat for a patient to experience an adverse event (NNTHAE), a serious adverse event (NNTHSAE), or treatment discontinuation due to an adverse event (NNTHAE-D) were used as measures of risk. The LHH-which is the ratio of NNTH:NNTB-values were calculated from published phase III trial data for oral DMTs.
RESULTS: The values for likelihood to achieve NEDA than experience any AE ratio (LHH(AE/NEDA)) were 3.5, 6.8, 12.5 and 2.6, the likelihood to achieve NEDA than experience a SAE ratio (LHH(SAE/NEDA)) values were 13.0, 3.5, 23.5 and 2.7, and the likelihood to achieve NEDA versus discontinue treatment (LHH(AE-D/NEDA)) values were 17.7, 6.5, 4.6 and 3.0 for cladribine, dimethyl-fumarate, fingolimod, and teriflunomide, respectively.
CONCLUSIONS: With all of the oral DMTs examined, R-MS patients are more likely to achieve NEDA than experience any adverse event.
OBJECTIVE: The objective of this study was to assess absolute differences in benefit:risk ratios of oral DMTs for R-MS, using LHH analysis with no evidence of disease activity (NEDA) as beneficial outcome.
DESIGN/METHODS: The number needed to treat for a paient to achieve NEDA (NNTBNEDA) was used as an effect size metric of efficacy and the number needed to treat for a patient to experience an adverse event (NNTHAE), a serious adverse event (NNTHSAE), or treatment discontinuation due to an adverse event (NNTHAE-D) were used as measures of risk. The LHH-which is the ratio of NNTH:NNTB-values were calculated from published phase III trial data for oral DMTs.
RESULTS: The values for likelihood to achieve NEDA than experience any AE ratio (LHH(AE/NEDA)) were 3.5, 6.8, 12.5 and 2.6, the likelihood to achieve NEDA than experience a SAE ratio (LHH(SAE/NEDA)) values were 13.0, 3.5, 23.5 and 2.7, and the likelihood to achieve NEDA versus discontinue treatment (LHH(AE-D/NEDA)) values were 17.7, 6.5, 4.6 and 3.0 for cladribine, dimethyl-fumarate, fingolimod, and teriflunomide, respectively.
CONCLUSIONS: With all of the oral DMTs examined, R-MS patients are more likely to achieve NEDA than experience any adverse event.