| Administration |
| (i) Most commonly prescribed DMT in the USA [8, 9] |
| (ii) Administered in clinical practice for over 20 years; over 2 million patient-years of exposure [60] |
| (iii) Dosing options of 20 mg daily or 40 mg three-times weekly via subcutaneous injection |
| (iv) Associated with a favorable rate of patient adherence [123, 124] |
| (a) Good patient acceptance of route of administration; support available from Shared Solutions® program |
| Efficacy |
| (i) GA 20 mg daily associated with 35% reduction in ARR, 22% reduction in disability progression |
| (network meta-analysis [125]), and decreased brain-lesion activity, compared with placebo |
| (ii) Few head-to-head studies with other DMTs in relapsing-remitting MS |
| (a) Similar efficacy to IFN betas in head-to-head studies for clinical (relapse, confirmed progression) and MRI activity |
| measures, although IFN beta treatments were found to limit the increase in lesion burden to a greater extent |
| than GA [68] |
| (b) Evidence (from network meta-analysis) of greater efficacy for alemtuzumab, mitoxantrone, and natalizumab |
| compared with GA in reducing ARR and for alemtuzumab with regard to disability worsening [105] |
| (iii) Data are not yet available from randomized controlled studies that investigate switching from other DMTs to GA |
| Safety |
| (i) Injection-site reactions were the most common adverse events reported in clinical trials (49% of patients; predominantly |
| erythema and pain) [60] |
| (a) Other common adverse events were rash (15%), headache (14%), infection (12%), dyspnea (12%), and vasodilation (11%) |
| (ii) No monitoring requirement |
| (iii) Pregnancy category B label in the USA; pregnancy contraindication removed from the EU label in December 2016 |
| (iv) No deaths associated with treatment in 20 clinical trials [60] |
| (v) No evidence of immunosuppression, autoimmune disease, or development of neutralizing antibodies [37, 60] |
| (vi) Postmarketing surveillance has not revealed risk for opportunistic infections (including PML) [60] |
