MACE, malignancies rarer in Latin American patients with rheumatoid arthritis
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Key takeaways:
- In patients with RA, malignancy and MACE were rarer in Latin American individuals vs. those who are not Latin American.
- Among Latin-American patients, risks for MACE and malignancy were higher in those who used tofacitinib vs. TNF inhibitors.
Latin American patients with rheumatoid arthritis experience fewer serious adverse events, including major adverse cardiovascular events and malignancy, than patients who are not Latin American, according to a study.
The data, the result of a post hoc analysis of the ORAL Surveillance study, additionally suggest that Lantin American patients who use tofacitinib (Xeljanz, Pfizer) have an increased risk for malignancy, MACE and venous thromboembolism vs. those who receive TNF inhibitors.
“Risk of [cardiovascular] disease is known to be impacted by race, ethnicity and geography due to genetic, environment and socioeconomic factors,” Gustavo Citera, MD, of the Instituto de Rehabilitación Psicofísica, in Buenos Aires, Argentina, and colleagues wrote in the Journal of Clinical Rheumatology. “As these factors can also influence pharmacokinetic or pharmacodynamic characteristics of drugs and therefore impact patient responses, it is important to assess the safety and efficacy of drugs across different populations.”
To examine the safety and efficacy of tofacitinib vs. TNF inhibitors among Latin American patients with RA, Citera and colleagues conducted a post hoc analysis of data from the ORAL Surveillance trial. The analysis compared the efficacy and safety of tofacitinib and TNF inhibitors in the global study population of 3,160 patients (mean age, 61.6 years) vs. “a [cardiovascular] risk-enriched” population of 1,202 Latin American patients with RA (mean age, 60 years).
The researchers compared the two groups’ incidence rates (IRs; patients with first event per 100 patient-years) and HRs for adverse events of special interest, such as major adverse cardiovascular events (MACE), malignancies excluding nonmelanoma skin cancer (NMSC), venous thromboembolism (VTE) and all-cause death.
Compared with the cohort of patients who were not Latin American, the Latin American cohort demonstrated a lower prevalence of risk factors associated with cardiovascular disease and malignancies, according to the researchers.
IRs for adverse events among patients receiving tofacitinib vs. TNF inhibitors in the Latin American vs. non-Latin American cohorts were as follows:
- MACE: 0.54 vs. 0.28 in Latin American patients; 1.14 vs. 0.92 for patients who were not Latin American;
- Malignancies excluding (NMSC): 0.58 vs. 0.27 in Latin American patients; 1.33 vs. 0.95 in those who were not Latin American; and
- All-cause death: 0.69 vs. 0.35 in Latin American patients; 0.63 vs. 0.33 in patients who were not Latin American.
Across treatment groups, incidence rates of NMSC and VTE were numerically lower among Latin American patients vs. patients who were not Latin American. As for efficacy, rates of Clinical Disease Activity Index low disease activity and remission were “generally similar” between treatments in each cohort, but “tended to be numerically higher” among Latin American patients, the researchers wrote.
“This post hoc analysis of the ORAL Surveillance study found that MACEs, malignancies excluding NMSC, VTE, and NMSC occurred less frequently in [Latin American (LATAM)] versus non-LATAM patients, reflecting key differences in baseline demographic characteristics between the cohorts,” Citera and colleagues wrote. “... In the LATAM cohort, IRs for these safety outcomes were higher with tofacitinib versus [TNF inhibitors (TNFi)], consistent with the overall findings of the ORAL Surveillance study.
“Efficacy outcomes were similar with tofacitinib versus TNFi and generally similar between LATAM and non-LATAM patients, although numerically larger response rates or improvements were observed in patients from LATAM for some outcomes,” they added. “Our findings emphasize the importance of assessing individual risk factors when considering tofacitinib as a treatment for patients with RA, to guide benefit/risk assessment and clinical decision-making.”
Perspective
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This post hoc analysis of the ORAL Surveillance trial reassures us that tofacitinib and TNF inhibitors offer comparable efficacy in the Latin American patient subgroup, despite a longer duration of disease and a higher prevalence of extra articular features than the non-Latin American subgroup.
Although safety data in Latin American patients trended similarly to the overall findings in the ORAL Surveillance trial, adverse event numbers were small and baseline risk factors were lower than the non-Latin American subgroup.
We welcome all ongoing efforts allowing rheumatologists to individualize risk/benefit analyses for rheumatoid arthritis therapies.
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