Table 1

Key study characteristics for all included studies in the NMA (only arms of interest)

StudyIntervention(s)Study designStudy durationSubgroup definition
Highly active RRMS
Subgroup analysis of FREEDOMS and FREEDOMS II20Fingolimod 0.5 mg once daily
Placebo
Post hoc subgroup analysis of double-blind, parallel-group, multicentre RCTs24 monthsPatients with high disease activity despite previous DMT use as specified in one of the following subgroups:Subgroup 1: those with one or more relapses in the previous year and either one or more Gd enhancing T1 lesions or at least nine T2 lesions at baseline;Subgroup 2: those with the same number or more relapses in the year before baseline than in the previous year
EPAR DMF18DMF 240 mg two times a day
Placebo
Post hoc subgroup analysis of double-blind, parallel-group, multicentre RCTs24 monthsPatients having at least one relapse in the past year while on therapy with β-interferon, and at least 9 T2 hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion or having an unchanged or increased relapse rate
Rapidly evolving severe RRMS
Subgroup analysis of FREEDOMS and FREEDOMS II23Fingolimod 0.5 mg once daily
Placebo
Post hoc subgroup analysis of double-blind, parallel-group, multicentre RCTs24 monthsTreatment naïve and at least 2 relapses in year 1 and at least 1 Gd+ lesion at baseline
Subgroup analysis of AFFIRM24 25Natalizumab 300 mg every 4 weeks
Placebo
Post hoc subgroup analysis of double-blind, parallel-group, multicentre RCT24 monthsSubgroup of patients who met the criteria for treatment-naïve highly active relapsing MS (≥2 relapses in the year prior to study entry and ≥1 Gd+ lesion on T1-weighted MRI at study entry)
  • DMF, dimethyl fumarate; DMT, disease-modifying therapy; EPAR, European Public Assessment Report; Gd, gadolinium; MS, multiple sclerosis; NMA, network meta-analysis; RCT, randomised controlled trial; RRMS, relapsing–remitting MS.