The Safety and Effectiveness of Infliximab Biosimilar in Managing Rheumatoid Arthritis: A Real-Life Experience from Jordan
Table 2
Adverse effects of Infliximab biosimilar in the safety population and their outcomes.
Adverse event
No. of patients, n (%)a
Time of occurrence (weeks since starting IFX therapy)
No. of events
Outcome
Blood and lymphatic system disorder
Anemia
1 (4.5)
12
1
Not recovered
Increased blood pressure
1 (4.5)
34
1
Recovered
Increased blood urea
1 (4.5)
31
1
Recovered
Leukopenia
1 (4.5)
7
1
Recovered
Cardiac disorders
Chest pain
2 (9.1)
33, 34
2
Recovered
Dyspnea
1 (4.5)
7, 32
2
Recovered
Gastrointestinal disorder
Gastrointestinal disorder
1 (4.5)
12
1
Recovered
Oropharyngeal pain
1 (4.5)
2
1
Recovered
General disorders and administration site conditions
Pyrexia
3 (13.6)
2, 4, 32
3
Recovered
Infection and infestation
Bronchitis
1 (4.5)
24
1
Recovered
Herpes zoster
1 (4.5)
1
1
Recovered
Investigation
Decreased blood creatinine
1 (4.5)
27
1
Recovered
Increased blood creatinine
1 (4.5)
31
1
Recovered
Decreased hemoglobin without anemia
3 (13.6)
23, 32, 32, 34
4
Recovering/recovered
Nervous system disorder
Dizziness
1 (4.5)
8
1
Recovered
Metabolism and nutrition disorders
Peripheral edema
1 (4.5)
14
1
Not recovered
Musculoskeletal and connective tissue disorder
Arthralgia
2 (9.1)
2
2
Recovered
Renal and urinary disorder
Dysuria
1 (4.5)
14
1
Not recovered
Renal colic
1 (4.5)
34
1
Recovered
Respiratory, thoracic, and mediastinal disorders
Productive cough
3 (13.6)
2, 3, 16, 31
4
Recovered
Rhinorrhea
1 (4.5)
2
1
Recovered
Sputum discolored
1 (4.5)
33
1
Recovered
Wheezing
1 (4.5)
33
1
Recovered
Skin and subcutaneous tissue disorders
Alopecia
1 (4.5)
8
1
Not recovered
Total
14 (63.6)
0–34
35
—
aPercentage represents the frequency of patients who developed the adverse event and was calculated by dividing the number of participants who developed the adverse event by the total sample size (n = 22).
