Primary progressive multiple sclerosis (PPMS) study design

The first and only approved PPMS therapy proven in a clinical study

ORATORIO Study Design 3
ORATORIO study design, key inclusion criteria, 2:1 randomization & ORATORIO trial endpoints. Studied over a median of 3 years.

Patients were randomized 2:1 and received either OCREVUS or placebo as two 300 mg IV infusions administered 2 weeks apart every 6 months throughout the treatment period.

OCREVUS: n=488
Placebo: n=244
*2005 revised McDonald criteria.

Important Safety Information

Warnings and Precautions
Infusion Reactions

OCREVUS can cause infusion reactions, which can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, and tachycardia. In multiple sclerosis (MS) clinical trials, the incidence of infusion reactions in OCREVUS-treated patients [who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions prior to each infusion] was 34-40%, with the highest incidence with the first infusion. There were no fatal infusion reactions, but 0.3% of OCREVUS-treated MS patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe patients treated with OCREVUS for infusion reactions during the infusion and for at least one hour after completion of the infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion.

Administer pre-medication (e.g., methylprednisolone or an equivalent corticosteroid, and an antihistamine) to reduce the frequency and severity of infusion reactions. The addition of an antipyretic (e.g., acetaminophen) may also be considered. For life-threatening infusion reactions, immediately and permanently stop OCREVUS and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

PPMS Patient Demographics 3
PPMS patient demographics for ORATORIO, OCREVUS vs placebo.
Proven in PPMS

OCREVUS was proven in PPMS across key clinical and MRI measures of efficacy.