Spondyloarthritis & psoriatic arthritis
Risk of serious infections, myocardial infarction or stroke, venous thromboembolic events, and malignancy in patients with psoriatic arthritis treated with tofacitinib compared with biologic treatments in the United States
Authors' conclusion
In patients with PsA who were not enriched for cardiovascular/VTE risk factors, no significant differences in the risk of serious infections, MI or stroke, or malignancy were reported in patients initiating tofacitinib versus biologic treatments. Tofacitinib was associated with a higher risk of VTE compared with TNFi, aligning with previous clinical data.
Study context
- Population
- Patients with PsA aged ≥ 18 years initiating tofacitinib or a biologic between December 2017-February 2023, with ≥ 12 months of prior continuous enrollment, United States (US)
- Participants
- 3,166 / 26,760 / 20,252 / 4,381 / 4,499
- Exposure
- Tofacitinib vs biologic treatments
- Tofacitinibn = 3,166
- TNFin = 26,760reference
- IL-17Ain = 20,252reference
- Risankizumabn = 4,381reference
- Ustekinumabn = 4,499reference
- Outcome
- Risk of serious infections, MI or stroke, VTE, and malignancy (excluding non-melanoma skin cancer)
Methodological detailsUS claims database (Komodo Health), stabilized inverse probability treatment weighting, Cox proportional hazards models, bootstrapped 95% CIs, Mean age at index 48.2 to 50.3 years; mean follow-up 288.5-347.0 days
- US claims database (Komodo Health)
- Stabilized inverse probability treatment weighting
- Cox proportional hazards models
- Bootstrapped 95% CIs
- Mean age at index 48.2 to 50.3 years; mean follow-up 288.5-347.0 days
Main finding
As reported in the abstract
Crude incidence rates (IRs)/100 patient-years (PY), serious infections (range)
1.78 to 2.53
Crude IRs/100 PY, myocardial infarction (MI)/stroke (range)
0.27-0.61
Crude IRs/100 PY, venous thromboembolism (VTE) (range)
0.17-0.42
Crude IRs/100 PY, malignancy (range)
0.74-1.06
Observational data: associations, not effects.
Further findings
Surgery (potential VTE risk factor), baseline period and 6 months post-index
- Tofacitinib initiators, baseline period
- 45.9-46.7%
- Tofacitinib initiators, 6 months post-index
- 28.1-28.9%
- Biologic initiators, baseline period
- 40.2-44.3%
- Biologic initiators, 6 months post-index
- 22.2-27.4%
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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