Oral Disease-Modifying Treatments for Relapsing Multiple Sclerosis: A Likelihood to Achieve No Evidence of Disease Activ
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ORIGINAL RESEARCH ARTICLE
Oral Disease‑Modifying Treatments for Relapsing Multiple Sclerosis: A Likelihood to Achieve No Evidence of Disease Activity or Harm Analysis Dimitrios Papadopoulos1 · Dimos‑Dimitrios D. Mitsikostas2
© Springer Nature Switzerland AG 2018
Abstract 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 3.9, 6.8, 12.5 and 3.7, the likelihood to achieve NEDA than experience a SAE ratio (LHH(SAE/NEDA)) values were 3.5, 15, 23.5 and 2.8, and the likelihood to achieve NEDA versus discontinue treatment ( LHH(AE-D/NEDA)) values were 20.3, 4.3, 3.9 and 3.1 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. Key Points The no evidence of disease activity (NEDA) concept is increasingly gaining recognition among specialists as a comprehensive measure of treatment response for relapsing multiple sclerosis (R-MS). Several oral disease-modifying treatments (DMTs) with tolerability and accessibility advantages over injectable treatments have now been approved.
* Dimos‑Dimitrios D. Mitsikostas [email protected] 1
Multiple Sclerosis Centre and Neurology Section, Athens Medical Centre - Paleo Phaliro Clinic, 175‑62 Athens, Greece
1st Neurology Department, Aeginition Hospital, Medical School, National and Kapodistrian University of Athens, 72‑74 V. Sofia’s Avenue, 11528 Athens, Greece
2
The likelihood to help or harm (LHH) metric could help practitioners present and explain the benefits and risks of available treatments to their patients. LHH analysis indicates that patients are more likely to achieve NEDA than risk an adverse event with all oral DMTs for R-MS. This analysis may help physicians, along with their patients, in selecting the right treatment for the right patient.
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1 Introduction The past two decades have seen an expansion of disease-modifying treatment (DMT) options indicated
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