Safety outcomes for TNFi on observational studies
| Study | Treatment group | N patients | Exposition patient-years | N events | IR /100,000py | Effect size Ratio* (95% CI) | SIR† (95% CI) | Risk of bias |
|---|---|---|---|---|---|---|---|---|
| Malignancies | ||||||||
| Carmona et al34 | Treated (3 TNFi‡) | 761 | 2288 | – | – | – | 0.92 (0.44 to 1.70) | Moderate |
| General population | NA | NA | NA | NA | ||||
| Dreyer et al35 | Treated (3 TNFi‡) | 861 | – | 8 | – | – | 0.82 (0.41 to 1.64) | Moderate |
| General population | NA | NA | NA | – | ||||
| Westhovens et al36 | Treated (females) (4 TNFi‡) | 74 | 1194 | – | 770.1 | – | 1.54 | Moderate |
| General population (females) | NA | (overall) | – | 499.1 | REF | |||
| Treated (males) (4 TNFi‡) | 157 | – | 370.2 | 1.31 | ||||
| General population (males) | NA | – | 283.4 | REF | ||||
| Infections | ||||||||
| Wallis37 | Any TNFi§ | 264 | 684 | 127 | 19/100py | 1.25 (0.90 to 1.73)¶ | – | Low |
| no-TNFi | 186 | 651 | 91 | 14/100py | REF | |||
| Moura et al38 | TNFi§ (±csDMARDs) | 714 | – | 57 | 2.44/100py | 1.05 (0.45 to 2,45)** | – | Low |
| Only csDMARDs | (overall) | (overall) | 4.12/100py | 1.77 (0.78 to 4,02)** | ||||
| None | 2.25/100py | REF | ||||||
| Tuberculosis | ||||||||
| Kim et al39 | Any TNFi | 354 | 1784 | 3 | 561 | 0.53 (0.14: 1.91)†† | – | Moderate |
| Infliximab | 78 | 366 | 2 | 540 | 1.57 (0.34 to 7.18) †† | |||
| Adalimumab | 66 | 204 | 1 | 308 | 1.33 (0.17 to 10.44)†† | |||
| Etanercept | 210 | 1214 | 0 | 0 | NA | |||
| Controls | 909 | 3247 | 10 | 308 | REF | |||
| Kim et al40 | Treated (5 TNFi‡) | 336 | 1166 | 7 | 600.2 | 4.9 (1.5 to 15.4)†† | – | Moderate |
| Controls | 986 | – | – | 123.1 | REF | |||
*Different effect sizes/ratios are provided in the different studies.
†SIR, Standardised Incidence Ratio (the ratio between observed and expected cases during follow-up).
‡3 TNFi (etanercept, infliximab, adalimumab), 4 TNFi (etanercept, infliximab, adalimumab, golimumab), 5 TNFi (etanercept, infliximab, adalimumab, golimumab, certolizumab);.
§Not specified;.
¶aOR: adjusted OR (adjusted for: age, disease duration, smoking, csDMARDs, oral steroids, BASDAI, BASFI, comorbidity score, hospitalisation);.
**aHR, adjusted HR (adjusted for baseline patient sociodemographics, comorbidities, prior health service use, time dependent use of NSAIDs, and corticosteroids);.
††Unadjusted HR;.
IR, incidence rate; NA, not applicable; py, patient-years; REF, reference group; TNFi, tumour necrosis factor inhibitors.