Table 3.
Safety outcomes in observational studies regarding GIP: comparison between TCZ and other bDMARDs/csDMARDs, tsDMARDs and general population
| Study | Treatment group | N patients | N events | Incidence rate (95% CI) |
aHR (I vs C) | |
| Monemi et al (2016)*120 | Combined TNF-i (ADA, ETN, IFX) | 17 333 | 10 | 0.6/1000 PY (0.3 to 1.2) | REF | REF |
| TCZ | 3602 | 6 | 1.8/1000 PY (0.7 to 4.0) | 2.2 (0.7 to 6.6) | 2.2 (0.9 to 5.4) | |
| Monemi et al (2016)†120 | Combined TNF-i (ADA, ETN, IFX) | 17 333 | 6 | 0.4/1000 PY (0.1 to 0.8) | REF | REF |
| TCZ | 3602 | 5 | 1.5/1000 PY (0.5 to 3.6) | 4.0 (1.1 to 14.1) | 3.1 (1.1 to 8.4) | |
| Rempenault et al (2019) (EULAR 2020)*119 | TCZ | 1496 | 9 | 2.3/1000 PY | TCZ vs RTX: 2.8 (1.5 to 5.1) TCZ vs ABA: 5.4 (1.4 to 19.9) |
|
| RTX | 1986 | 8 | 1.3/1000 PY | |||
| ABA | 1019 | 2 | 0.8/1000 PY | |||
| Rempenault et al (2019) (EULAR 2020)§119 | TCZ | 1496 | 6 | 1.5/1000 PY | TCZ vs RTX: 3.8 (1.7 to 8.5) TCZ vs ABA: 6.9 (1.9 to 25.4) |
|
| RTX | 1986 | 3 | 0.5/1000 PY | |||
| ABA | 1019 | 2 | 0.8/1000 PY | |||
| Rempenault et al (2019) (EULAR 2020)¶ 119 |
TCZ | 1496 | 3 | 0.7/1000 PY | TCZ vs RTX: 1.4 (0.5 to 3.9) TCZ vs ABA: NAP |
|
| RTX | 1986 | 5 | 0.8/1000 PY | |||
| ABA | 1019 | 0 | – | |||
| Strangfeld et al (2017)†121 | csDMARD | 4423 | 11 | 0.61/1000 PY (0.3 to 1.1) | REF | |
| TNF-i | 6711 | 13 | 0.52/1000 PY (0.3 to 0.9) | 1.04 (0.48 to 2.26) | ||
| TCZ | 877 | 11 | 2.69/1000 PY (1.4 to 4.8) | 4.48 (2.01 to 9.99) | ||
| other bDMARDs (RTX+ABA) | NR | NR | NR | 0.33 (0.08 to 1.44) | ||
| Barbulescu et al (2020)†122 | General population | 76 304 | 333 | 1.07/1000 PY (0.95 to 1.33) | REF | NAP |
| Bionaïve patients with RA | 62 532 | 570 | 1.60/1000 PY (1.46 to 1.74) | 1.02 | NAP | |
| TNF-i | 17 594 | 57 | 1.84/1000 PY (1.38 to 3.63) | 0.99 | REF | |
| ABA | 2527 | 13 | 3.32/1000 PY (1.66 to 16.6) | 1.41 | 1.07 (0.55 to 2.10) | |
| RTX | 3552 | 22 | 2.02/1000 PY (1.26 to 5.65) | 1.07 | 0.89 (0.50 to 1.58) | |
| TCZ | 2377 | 22 | 4.51/1000 PY (2.68 to 10.4) | 2.36 | 2.20 (1.28 to 3.79) | |
| Xie et al (2016)*123 | Combined TNF-i | 115 044 | 109 | 0.83/1000 PY (0.69 to 1.00) | NR | |
| TCZ | 11 705 | 16 | 1.55/1000 PY (0.95 to 2.54) | NR | ||
| TOFA | 4755 | 3 | 0.86/1000 PY (0.10 to 3.60) | NR | ||
| Xie et al (2016)†123 | Combined TNF-i | 115 044 | 59 | 0.46/1000 PY (0.35 to 0.58) | REF | |
| ABA | 31 214 | 30 | 0.76/1000 PY (0.53 to 1.09) | 1.41 (0.90 to 2.21) | ||
| RTX | 4391 | 2 | 0.48/1000 PY (0.06 to 1.75) | 1.72 (0.52 to 5.69) | ||
| TCZ | 11 705 | 13 | 1.26/1000 PY (0.73 to 2.18) | 2.55 (1.33 to 4.88) | ||
| TOFA | 4755 | 2 | 0.86/1000 PY (0.10 to 3.60) | 3.24 (1.05 to 10.04) | ||
| Xie et al (2016)‡123 | Combined TNF-i | 115 044 | 49 | 0.38/1000 PY (0.28 to 0.50) | NR | |
| ABA | 31 214 | 12 | 0.31/1000 PY (0.17 to 0.54) | NR | ||
| RTX | 4391 | 1 | 0.24/1000 PY (0.01 to 1.35) | NR | ||
| TCZ | 11 705 | 3 | 0.29/1000 PY (0.06 to 0.85) | NR | ||
| TOFA | 4755 | 0 | 0.00/1000 PY (0.00 to 1.58) | NR | ||
Detailed results are shown in online supplemental tables S4.5.2.1–S4.5.2.3.
*Any GIP.
†Lower GIP.
‡Upper GIP.
§GIP due to diverticulitis (diverticular GIP).
¶GIP due to another aetiology.
ABA, abatacept; ADA, adalimumab; aHR, adjusted HR; bDMARD, biological DMARD; C, control; CI, confidence interval; csDMARD, conventional synthetic DMARD; DMARD, disease-modifying antirheumatic drug; ETN, etanercept; GIP, gastrointestinal perforations; I, intervention; IFX, infliximab; N, number; NAP, not applicable; NR, not reported; PY, patient years; REF, reference; RTX, rituximab; TCZ, tocilizumab; TNF-i, tumour necrosis factor inhibitor; TOFA, tofacitinib; tsDMARD, target synthetic DMARD.