Table 3.
Adverse events reported in the included studies.
| First author (year) | Sample size (n) | Follow-up (years) a | AEs (n) | Severe AEs (%) b | Detailed safety information |
|---|---|---|---|---|---|
| Al Rashidi et al. (2013) | 19 | 3.67 | 1 | 1 (5.26) | One patient developed a severe infusion reaction during the 19th scheduled infusion |
| Bawazeer et al. (2010) | 11 | 0.9 | 0 | 0 (0) | None |
| Bejerano et al. (2013) | 63 | 2 | 1 | 1 (1.59) | Miliary TB in 1 patient at month 1 after the onset of IFX. |
| Calvo-Río et al. (2013) | 108 | 2 | NA | NA | NA |
| Calvo-Rio et al. (2014) | 124 | 1 | NA | 3 (2.4) | Minor side effects: mild infusion reactions and local reactions (pain and erythema). Severe AEs were observed in 3 case: one patient had miliary TB after 1 month of IFX, another was diagnosed with non-Hodgkin’s lymphoma in month 6 of ADA treatment, and one patient who died was diagnosed with melanoma in month 3 of treatment with ADA. |
| Cantini et al. (2012) | 50 | 2 | 0 | 0 (0) | None |
| Yalcindag and Kose (2019) | 20 | 1.73 | 3 | NA | Three patients were switched to a different agent because of AEs. |
| Domínguez Casas et al. (2017) | 100 | 1 | 4 | 4 (4) | Severe AEs were lymphoma (n=1), pneumonia (1), and bacteriemia (2 by Escherichia coli) |
| El Garf et al. (2018) | 20 | 1.17 | 8 | 0 (0) | Mild infusion reactions in 4 patients, frequent urinary tract infections in 1 patient, and frequent upper airway infections in 3 patients |
| Fabiani et al. (2017) | 40 | 1 | 1 | 1 (2.27) | One severe AE: pneumonia. |
| Hamuryudan et al. (2013) | 43 | 2.42 | 5 | 4 (9.30) | Pulmonary TB in 3 patients (in month 17, 32, and 46 of IFX treatment). Pneumonia in 1 patient and depression in 1 patient. |
| Interlandi et al. (2014) | 12 | 1.75 | 0 | 0 (0) | None |
| Katsuyama et al. (2019) | 11 | 2 | 4 | 0 (0) | Urinary tract infection in 1 patient and significant cataract progression in 1 patient. Two patients exhibited transient elevation of serum creatinine levels. |
| Keino et al. (2011) | 14 | 1.58 | 10 | 0 (0) | Infusion reactions (rash, itchiness and/or respiratory distress) in 4 patients and common cold symptoms in 5 patients. One patient had suspected bacterial pharyngitis that responded to antibiotic therapy. |
| Martín-Varillas et al. (2018) | 74 | 2.89 | 4 | 4 (5.41) | Severe AEs were found in 4 patients (lymphoma, pneumonia, severe local reaction at the injection site, and bacteremia by Escherichia coli; 1 each). |
| Mesquida et al. (2013) | 32 | 6.44 | 3 | 2(5.25) | One severe infusion reaction, 1 case of pulmonary tuberculosis, and 1 case of prostatitis |
| Okada et al. (2012) | 63 | 1 | NA | 0(0) | Urticaria and rash, infusion reactions and decreased blood pressure were observed, but the number with each AE was not mentioned. |
| Takeuchi et al. (2014) | 164 | 2.74 | 65 | 2 (1.22) | AEs were observed in 65 cases and included infusion reaction (21% incidence), upper respiratory inflammation (4% incidence) and gastroenteritis (3% incidence). Pneumonia occurred in 2 patients (3%). c |
NA, not available; AEs, adverse events; IFX, infliximab; ADA, adalimumab; TB, tuberculosis.
a
The mean duration of follow-up.
b
The percentage of severe AEs observed in all subjects in each study, marked as a number (percentage).
c
The incidence indicates the proportion of patients with one particular reaction out of all of the AEs reported in this study.