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ORAL Surveillance compared tofacitinib with TNF inhibitors in patients with rheumatoid arthritis aged 50 years or older who had at least one cardiovascular risk factor. The trial identified higher rates of major adverse cardiovascular events and malignancy with tofacitinib than with TNF inhibitors in the studied population, prompting regulatory and guideline changes around the use of JAK inhibitors. For physicians, the practical lesson is that treatment selection cannot rely solely on efficacy. Age, smoking history, cardiovascular disease, thrombotic risk, malignancy risk and other comorbidities should be incorporated into the choice of targeted therapy. The findings do not mean that JAK inhibitors are unusable, but they do support more careful risk stratification and shared decision-making. This is especially important in older patients with multiple comorbidities, where absolute event rates may matter more than relative differences. The study also illustrates why post-marketing safety evidence can alter routine practice after a therapy has already entered widespread use. Regular reassessment of risk and benefits is therefore an important part of long-term rheumatology care.
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ORAL Surveillance compared tofacitinib with TNF inhibitors in patients with rheumatoid arthritis aged 50 years or older who had at least one cardiovascular risk factor. The trial identified higher rates of major adverse cardiovascular events and malignancy with tofacitinib than with TNF inhibitors in the studied population, prompting regulatory and guideline changes around the use of JAK inhibitors. For physicians, the practical lesson is that treatment selection cannot rely solely on efficacy. Age, smoking history, cardiovascular disease, thrombotic risk, malignancy risk and other comorbidities should be incorporated into the choice of targeted therapy. The findings do not mean that JAK inhibitors are unusable, but they do support more careful risk stratification and shared decision-making. This is especially important in older patients with multiple comorbidities, where absolute event rates may matter more than relative differences. The study also illustrates why post-marketing safety evidence can alter routine practice after a therapy has already entered widespread use. Regular reassessment of risk and benefits is therefore an important part of long-term rheumatology care.
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