Safety and Efficacy of Rituximab in Multiple Sclerosis: A Retrospective Observational Study

Table 2

Adverse events and serious adverse events (safety population).

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All events

Any event: (71.9%)

Any event leading to discontinuation of the drug: (1.1%)

PML: none

Death: none

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Infusion reactions (); 8.7%

(i) Mild reaction during first cycle ()

(ii) Mild reaction during second cycle ()

(iii) Mild reaction during third cycle ()

(iv) Mild reaction during ≥ fourth cycle ()

Infections (); 15.7%

(i) Urinary tract infections:

(ii) Upper and lower respiratory tract infections:

(iii) Flu:

Dermatological adverse events () – 4.5%

(i) Pityriasis rosea:

(ii) Seborrheic dermatitis:

Fatigue (); 3.4%

Laboratory abnormalities (); 3.4%

(i) Lymphopenia (ALC = 665):

(ii) Eosinophilia (7%):

(iii) Anemia:

GI (nausea, abdominal pain, bloating, flatulence):

Weight gain:

Sexual dysfunction:

Hip fracture:

Headache:

Arthralgia:

Paresthesia in fingers:

Hair loss:

Loss of appetite:

Urinary urgency:

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Serious adverse events requiring hospitalizations and surgical interventions (); 2.2%

(i) Increase in the size of a preexisting meningioma with central cystic formation and enhancement 21 months after initiating rituximab therapy:

(ii) Fungal vaginal infection, vaginitis, pyoderma gangrenosum vaginalis, perianal abscess with fistula formation 38 months after initiating rituximab therapy:

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PML = progressive multifocal leukoencephalopathy; ALC = acute lymphocytic count; GI = gastrointestinal.