Table 1:

Summary of clinical findings from randomized controlled trials of drugs used for disease-modifying treatment of relapsing–remitting multiple sclerosis

DrugTreatment regimenTrial duration, yrAnnualized relapse rate (%reduction v. placebo)Progression to disability* (% reduction v. placebo)Adverse effects
Glatiramer acetate520 mg SC daily2Drug: 0.59
Placebo: 0.84 (29%)		% of patients without progression:
Drug: 78.4
Placebo: 75.4 (12%; NS†)

  • Local reaction at injection site

  • Systemic reaction after injection

  • Allergic reaction

Interferon β-1b6250 μg SC every other day3Drug: 0.84
Placebo: 1.17 (28%)		% of patients with stable EDSS score:
Drug: 73
Placebo: 61 (29%; p = 0.161)

  • Local reaction at injection site

  • Flu-like syndrome after injection

  • Liver and thyroid dysfunction (usually reversible)

  • Leukopenia

  • Mood disorders

Interferon β-1a730 μg IM weekly2Drug: 0.61
Placebo: 0.9 (32%)		% of patients with disability progression:
Drug: 21.9
Placebo: 34.9 (37%)		Same as interferon β-1b
Interferon β-1a822 or 44 μg SC, 3 times weekly2Drug 22 μg: 1.82
Drug 44 μg: 1.73
Placebo: 2.56 (22 μg: 27%; 44 μg: 33%)		1st quartile time to progression in months:
Drug 22 μg: 18.5
Drug 44 μg: 21.3
Placebo: 11.9 (22 μg: NA; 44 μg: 30%)		Same as interferon β-1b
Natalizumab9300 mg IV monthly2Drug: 0.24
Placebo: 075 (68%)		Cumulative probability of progression:
Drug: 17
Placebo: 29 (42%)

  • Liver dysfunction

  • Allergic reactions

  • Progressive multifocal leukoencephalopathy

Fingolimod100.5 mg PO daily2Drug: 0.18
Placebo: 0.24 (54%)		Cumulative probability of progression:
Drug: 17.7
Placebo: 24.1 (32%)

  • Liver dysfunction

  • Bradycardia, increased QT interval

  • Leukopenia and lymphopenia

  • Increased risk of varicella-zoster virus infection

  • Macular edema

Dimethyl fumarate11240 mg PO twice daily2Drug: 0.36
Placebo: 0.17 (53%)		% of patients with disability progression:
Drug: 16
Placebo: 27 (38%)

  • Flushing

  • Gastrointestinal disturbances (nausea, diarrhea)

  • Lymphopenia

Teriflunomide1214 mg PO daily2Drug: 0.37
Placebo: 0.54 (31%)		% of patients with disability progression:
Drug: 20.2
Placebo: 27.3 (29.8%)

  • Gastrointestinal disturbances (nausea, diarrhea)

  • Urinary tract infection

  • Liver dysfunction

  • Leukopenia

  • Teratogenic effects

  • Note: EDSS = Expanded Disability Status Scale, IM = intramuscularly, IV = intravenously, NA = not available, NS = not significant, PO = orally, SC = subcutaneously.

  • ↵* Progression of disability was assessed using the EDSS score. If not specified in the table, differences between the treated and placebo groups are considered statistically significant (see referenced papers for details). Data are reported only for approved treatment regimens.

  • ↵† p value not reported in the original article.