Table 3.
HRs (95% CIs) of potential baseline risk factors for SIEs and NSIs in ORAL Surveillance (multivariable Cox analyses performed for individual treatments)
| Baseline risk factor comparisons, HR (95% CI) |
Tofacitinib 5 mg two times per day (N=1455) | Tofacitinib 10 mg two times per day (N=1456) | TNFi (N=1451) |
| SIEs | |||
| Age: increase of 5 years | 1.28 (1.14 to 1.44)*** | 1.32 (1.19 to 1.47)*** | 1.26 (1.13 to 1.41)*** |
| Positive for anticitrullinated protein antibodies: yes versus no | 2.08 (1.29 to 3.36)** | ||
| BMI: ≥30–<35 versus <30 kg/m2 | 1.72 (1.18 to 2.52)** | 1.37 (0.97 to 1.92) | |
| BMI: ≥35 versus <30 kg/m2 | 1.51 (0.96 to 2.38) | 0.77 (0.49 to 1.21) | |
| Opioid use on day 1: yes versus no | 1.63 (1.13 to 2.36)** | 1.67 (1.19 to 2.35)** | 1.91 (1.30 to 2.81)** |
| History of chronic lung disease (COPD or ILD): yes versus no | 2.13 (1.42 to 3.20)*** | 1.47 (0.98 to 2.23) | 1.85 (1.18 to 2.89)** |
| History of extra-articular disease: yes versus no | 1.36 (0.97 to 1.19) | ||
| History of heart failure: yes versus no | 2.17 (0.94 to 5.01)* | 2.82 (1.03 to 7.75)* | |
| History of infection: yes versus no | 1.34 (0.98 to 1.81) | 1.51 (1.05 to 2.17)* | |
| NSIs | |||
| Sex: male versus female | 0.73 (0.62 to 0.87)*** | 0.69 (0.59 to 0.81)*** | 0.77 (0.65 to 0.91)** |
| Race: non-white versus white | 1.19 (1.03 to 1.38)* | ||
| Smoking status: past smoker versus never smoked | 1.34 (1.14 to 1.58)*** | ||
| Smoking status: current smoker versus never smoked | 1.01 (0.87 to 1.18) | ||
| Opioid use day 1: yes versus no | 1.19 (1.02 to 1.39)* | 1.21 (1.03 to 1.43)* | |
| History of chronic lung disease (COPD or ILD): yes versus no | 1.38 (1.15 to 1.66)*** | 1.32 (1.09 to 1.59)** | 1.30 (1.06 to 1.59)* |
| History of chronic renal disease: yes versus no | 2.52 (1.39 to 4.59)** | 2.16 (1.19 to 3.93)* | |
| History of extra-articular disease: yes versus no | 1.21 (1.06 to 1.37)** | ||
| History of infection: yes versus no | 1.21 (1.06 to 1.37)** | 1.31 (1.15 to 1.49)*** | 1.27 (1.11 to 1.45)*** |
For patients randomised to the tofacitinib 10 mg two times per day group who had their dose of tofacitinib reduced to 5 mg two times per day, the data collected after patients were switched to tofacitinib 5 mg two times per day were counted in the tofacitinib 10 mg two times per day group. HRs (95% CIs) were based on a backward selection algorithm used on a multivariable Cox model including candidate baseline risk factors previously selected via a simple Cox model; risk factors with p<0.10 in the simple model (see online supplemental table 4) were entered into the multivariable model, and the risk factors with p<0.10 were retained in the multivariable model, with p<0.05 interpreted as predictive. Blank cells indicate risk factors that were not included but retained in the final multivariable Cox model for that particular treatment (ie, risk factors with p≥0.10 in the final multivariable model).
*p<0.05; **p<0.01; ***p<0.001.
BMI, body mass index; COPD, chronic obstructive pulmonary disease; ILD, interstitial lung disease; NSI, non-serious infection; SIE, serious infection event; TNFi, tumour necrosis factor inhibitors.