Safety Profile
...with no additional safety concerns over a 52 week follow up duration.1,2
| N (%) | TOFIDENCE (N=290) |
rTCZ/ TOFIDENCE (N=142) |
rTCZ (N=145) |
|---|---|---|---|
| TEAE | 162 (55.9) | 92 (64.8) | 90 (62.1) |
| Related TEAE | 112 (38.6) | 64 (45.1) | 59 (40.7) |
| Serious TEAE | 8 (2.8) | 5 (3.5) | 4 (2.8) |
| Related serious TEAE | 2 (0.7) | 1 (0.7) | 1 (0.7) |
Adapted from: Leng X, et al. 2022
Additional Safety Profile Information2
The most commonly reported ADRs (occurring in ≥5% of patients treated with tocilizumab monotherapy or in combination with DMARDs for RA, sJIA and pJIA) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT. The most serious ADRs were serious infections, complications of diverticulitis, and hypersensitivity reactions. Very commonly (≥ 1/10) reported ADRs from clinical trials and/or post marketing experience with tocilizumab are upper respiratory tract infections and hypercholesterolemia. For a detailed listing of ADRs, please see section 4.8 of the Summary of Product Characteristics.2
In the comparative clinical trial, a total of 1,261 TEAEs were reported for 397 (63·9%) patients; 624 TEAEs in 196 (63·4%) patients in the rTCZ group and 637 TEAEs in 201 (64·4%) patients in the TOFIDENCE group. Related TEAEs occurred in 151 (48·9%) and 148 (47·4%) subjects in the rTCZ and TOFIDENCE groups, respectively, most of which were mild in severity (mild: 131 [42·4%] and 126 [40·4%]; moderate 56 [18·1%] and 42 [13·5%]; severe 8 [2·6%] and 5 [1·6%]). In addition, 19 serious TEAEs were reported in 13 (4·2%) patients in the rTCZ group and 13 serious TEAEs in 11 (3·5%) patients in the TOFIDENCE group. For more details, please refer to the publication from Leng X. et al., 2024.3
During TP1 (24 weeks), 42 (13·6%) and 64 (20·5%) subjects in the rTCZ and TOFIDENCE groups, respectively, had ≥1 positive ADA result at any time. The proportion of subjects testing positive for ADAs (in the majority with titers ≤20) increased from 1·6% (of 309 subjects) to 6·2% (of 274 subjects) in the rTCZ group at Weeks 0 to 24, and from 1·3% (of 312 subjects) to 10·4% (of 353 279 subjects), respectively, in the TOFIDENCE group. For more details, please refer to the publication from Leng X. et al., 2024.3
During TP2 (24 to 48 weeks), ADAs were reported at least once ADAs were reported at least once in 21.0%, 18.6%, and 16.2% of patients in the TOFIDENCE, rTCZ ➔ TOFIDENCE, and rTCZ groups, respectively. Analysis of the primary endpoint by ADA status showed no notable differences in either treatment group. For more details, please refer to the publication from Leng X. et al., 2022.1
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Abbreviations: ADA, anti-drug antibody; ADR, adverse drug reaction; ALT, alanine aminotransferase; DMARD, disease modifying anti-rheumatic drug; pJIA, polyarticular juvenile idiopathic arthritis; RA, rheumatoid arthritis; rTCZ, reference tocilizumab; sJIA, systematic juvenile idiopathic arthritis, TEAE, treatment emergent adverse event.
