Table 2.
Reporting odds ratio and empirical Bayesian geometric mean values for VTE, MI, and CVA composites
| JAKinibs (FDA approval date) | Composite | Primary suspect cases | ROR (95% CIa) | EBGM (95% CIa) |
|---|---|---|---|---|
|
Ruxolitinib 16 Nov 2011 |
CTEc | 328 | 0.90 (0.81–1.00) | 1.11b (1.01) |
| MI | 176 | 0.44 (0.38–0.52) | 0.55 (0.49) | |
| CVA | 355 | 0.66 (0.60–0.74) | 0.82 (0.75) | |
|
Tofacitinib 6 Nov 2012 |
CTEb | 352 | 1.04 (0.94–1.16) | 1.06 (0.97) |
| MI | 228 | 0.61 (0.54–0.70) | 0.63 (0.56) | |
| CVA | 312 | 0.62 (0.55–0.69) | 0.63 (0.58) | |
|
Tofacitinib XR 24 Feb 2016 |
CTE | 100 | 0.58 (0.47–0.70) | 0.59 (0.50) |
| MI | 74 | 0.49 (0.39–0.62) | 0.50 (0.41) | |
| CVA | 108 | 0.41 (0.34–0.49) | 0.41 (0.35) | |
|
Upadacitinib 16 Aug 2019 |
CTEd | 1 | 6.83 (0.94–49.56) | 1.42 (0.23) |
| MI | 0 | NA | NA | |
| CVAd | 1 | 4.69 (0.65–34.05) | 1.16 (0.20) | |
|
Baricitinib 31 May 2018 |
CTEc | 41 | 7.43b (5.45–10.13) | 4.83b (3.70) |
| MI | 10 | 2.22b (1.19–4.13) | 1.42 (0.82) | |
| CVA | 17 | 2.00b (1.24–3.22) | 1.15 (0.77) |
CI confidence interval, CTE composite thromboembolic event, CVA cerebrovascular accident, EBGM empirical Bayesian geometric mean, JAKinibs Janus kinase inhibitors, MI myocardial infarction, NA not available, ROR reporting odds ratio, TE thromboembolic event, VTE venous thromboembolism, XR extended release
aTwo-sided CI for ROR; one-sided CI for EBGM
bROR or EBGM lower-bound CI values > 1
cBoth ROR and EBGM lower-bound CI values were > 1.0
dA trend where both ROR and EBGM were above 1.0, but neither lower-bound CI was above 1.0