Patients with rheumatoid arthritis (RA) were treated with Rituxan in controlled and long-term studies.[13]

ADVERSE EVENTS

Most Common Adverse Events in RA Clinical Trials Up to 6 Months

These data are based on 938 patients treated during a 24-week period in Phase 2 and Phase 3 studies of Rituxan (2 x 1000 mg) or placebo administered in combination with methotrexate.

Adverse reactions reported in  ≥5% of patients were hypertension, nausea, upper respiratory tract infection, arthralgia, pyrexia, and pruritus.[13]

Incidence of Rituxan adverse events ≥2% and at least 1% greater than placebo[13]

 

RITUXAN + MTX

(n=540)

PLACEBO + MTX

(n=398)

Hypertension

8%

5%

Nausea

8%

5%

Upper respiratory tract infection

7%

6%

Arthralgia

6%

4%

Pyrexia

5%

2%

Pruritus

5%

1%

Chills

3%

2%

Rhinitis

3%

2%

Dyspepsia

3%

<1%

Upper abdominal pain

2%

1%

Migraine

2%

<1%

Anxiety

2%

1%

Asthenia

2%

<1%

Paresthesia

2%

<1%

Urticaria

2%

<1%

Throat irritation

2%

0

MTX=methotrexate.
Adapted from the Rituxan Prescribing Information.
Coded using MedDRA.