TOPLINE: 

In patients with psoriatic arthritis (PsA), tofacitinib demonstrated safety comparable to biologics, with no significant differences in the risk for serious infections, myocardial infarction or stroke, and malignancy. However, tofacitinib was associated with a higher risk for venous thromboembolism (VTE) than TNF inhibitors.

METHODOLOGY: 

• Researchers conducted a retrospective cohort study using the Komodo Research Dataset, analyzing adult patients with PsA who initiated tofacitinib or biologic treatments between December 2017 and February 2023.
• They included 48,167 patients (mean age range at the index date, 48.2-50.3 years), each of whom could be deemed a new user once for each drug: 3166 initiated tofacitinib, 26,760 initiated TNF inhibitors, 20,252 initiated interleukin-17A (IL-17A) inhibitors, 4381 initiated risankizumab, and 4499 initiated ustekinumab.
• The mean follow-up period ranged from 288.5 to 347.0 days across treatment groups. Patients may have received baseline conventional treatments including methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, and others.
• Safety events of interest were serious infections (bacterial, fungal, and viral infections requiring hospitalization), myocardial infarction or stroke, VTE, and malignancy (excluding non-melanoma skin cancer), with a 6-month lag time applied for malignancy outcomes to prevent misclassification.
• Crude incidence rates per 100 patient-years were calculated, and Cox proportional hazards models with stabilized inverse probability of treatment weighting were used to estimate adjusted hazard ratios (aHRs) for safety events, with tofacitinib as the reference group and bootstrapping used to calculate 95% CI.

TAKEAWAY: 

• No statistically significant differences were observed in the risk for serious infections, myocardial infarction or stroke, or malignancy (excluding non-melanoma skin cancer) between patients who initiated tofacitinib and those who initiated biologics.
• Crude incidence rates per 100 patient-years ranged from 1.78 to 2.53 for serious infections, 0.27 to 0.61 for myocardial infarction or stroke, and 0.74 to 1.06 for malignancy (excluding non-melanoma skin cancer) across all treatment groups.
• Patients who initiated tofacitinib had a significantly higher risk for VTE than those who initiated TNF inhibitors (aHR for TNF inhibitors vs tofacitinib, 0.27; 95% CI, 0.13-0.62), but no significant differences were noted in the risk when comparing tofacitinib with other biologics.
• In a sensitivity analysis excluding patients with a history of malignancy or other immune conditions, tofacitinib was associated with a higher risk for VTE than both TNF inhibitors (aHR, 0.21; 95% CI, 0.10-0.48) and IL-17A inhibitors (aHR, 0.29; 95% CI, 0.14-0.66).

IN PRACTICE: 

“[The study] findings provide valuable insights into the application of relative-risk estimates for safety events, which are crucial for clinical decision-making in patients with PsA,” the authors of the study wrote, further highlighting “the need for careful assessment and monitoring of VTE risks in tofacitinib treatment of patients with PsA.”

SOURCE: 

The study was led by Marina Magrey, MD, Case Western Reserve University, University Hospitals in Cleveland. It was published online on March 25, 2026, in Arthritis Research & Therapy.

LIMITATIONS: 

Potential misclassification of diagnoses may have occurred due to reliance on diagnostic codes. Certain important infections such as herpes zoster and opportunistic infections typically do not require hospitalization, and the same applies to deep vein thrombosis. Outpatient prescription data did not verify actual medication use or adherence, and over-the-counter or sample medications were not included. The mean follow-up period of approximately 1 year was relatively short and may not have been enough to identify long-term outcomes.

DISCLOSURES: 

The study was sponsored by Pfizer. One author disclosed serving as a consultant and receiving grants or research support from multiple sources. Six authors reported being employees and stockholders of Pfizer. Additionally, one author disclosed employment with Komodo Health, which was compensated by Pfizer for analytics services. Another author reported serving as a consultant for Pfizer and receiving grant support from the company.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.