Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance
Abstract Introduction In ORAL Surveillance, incidence rates (IRs) of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) in cardiovascular (CV)-risk-enriched patients with rheumatoid arthritis (RA) were numerically greater with tofacitinib in North...
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Adis, Springer Healthcare
2024-07-01
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| Series: | Rheumatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40744-024-00693-y |
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| author | Bogdan Batko Slawomir Jeka Piotr Wiland Agnieszka Zielińska Maria Stopińska-Polaszewska Marcin Stajszczyk Magdalena Kosydar-Piechna Mary Jane Cadatal Jose L. Rivas |
| author_facet | Bogdan Batko Slawomir Jeka Piotr Wiland Agnieszka Zielińska Maria Stopińska-Polaszewska Marcin Stajszczyk Magdalena Kosydar-Piechna Mary Jane Cadatal Jose L. Rivas |
| author_sort | Bogdan Batko |
| collection | DOAJ |
| description | Abstract Introduction In ORAL Surveillance, incidence rates (IRs) of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) in cardiovascular (CV)-risk-enriched patients with rheumatoid arthritis (RA) were numerically greater with tofacitinib in North America versus the rest of the world, due to underlying risk factors. Here, we evaluated the safety and efficacy of tofacitinib versus tumor necrosis factor inhibitors (TNFi) among patients with RA across geographical regions. Methods Patients with RA in ORAL Surveillance (NCT02092467), who were aged ≥ 50 years with ≥ 1 additional CV risk factor, received tofacitinib 5 or 10 mg twice daily or TNFi; 45.9% were from either Poland or North America. This post hoc analysis stratified patients by region (Poland, North America, Other countries). Efficacy endpoints included Clinical Disease Activity Index, Disease Activity Score in 28 joints, with C-reactive protein (DAS28-4[CRP]), and Health Assessment Questionnaire-Disability Index (HAQ-DI). IRs and hazard ratios for adverse events were reported. Results Of 4362 patients (Poland, N = 759; North America, N = 1243; Other countries, N = 2360), more patients from North America versus Poland/Other countries had CV risk factors such as body mass index ≥ 30 kg/m2 and history of diabetes/hypertension; however, more patients from Poland versus other regions were ever smokers and more patients from Poland/North America versus Other countries had history of coronary artery disease. MACE IRs were similar in North America and Poland, and numerically higher versus Other countries. IRs for malignancies (excluding NMSC) were numerically higher in North America versus Poland/Other countries with tofacitinib. Serious infections IRs were numerically higher in North America versus Poland across treatments. Venous thromboembolism/all-cause mortality IRs were generally comparable across regions. DAS28-4(CRP)/HAQ-DI improvements were generally lowest in North America. Conclusions Differences in safety outcomes were driven by the presence of baseline risk factors; North America and Poland demonstrated a higher proportion of patients with some baseline CV risk factors/comorbidities versus Other countries. Trial Registration NCT02092467 (ClinicalTrials.gov). |
| format | Article |
| id | doaj-art-8b3daa8c9bbd4da58e1330c0d2aa0e16 |
| institution | Kabale University |
| issn | 2198-6576 2198-6584 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | Adis, Springer Healthcare |
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| series | Rheumatology and Therapy |
| spelling | doaj-art-8b3daa8c9bbd4da58e1330c0d2aa0e162025-01-26T12:52:04ZengAdis, Springer HealthcareRheumatology and Therapy2198-65762198-65842024-07-011151217123510.1007/s40744-024-00693-yGeographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL SurveillanceBogdan Batko0Slawomir Jeka1Piotr Wiland2Agnieszka Zielińska3Maria Stopińska-Polaszewska4Marcin Stajszczyk5Magdalena Kosydar-Piechna6Mary Jane Cadatal7Jose L. Rivas8Department of Rheumatology and Immunology, Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski UniversityClinic and Department of Rheumatology and Connective Tissue Diseases, University Hospital No. 2, Collegium Medicum, Nicolaus Copernicus University in ToruńDepartment of Rheumatology and Internal Medicine, Wroclaw Medical UniversityMedycyna Kliniczna Marzena Waszczak-JekaNasz Lekarz Ośrodek Badań KlinicznychDepartment of Rheumatology and Autoimmune Disease, Silesian Center for Rheumatology, Orthopedics and RehabilitationPfizer IncPfizer IncPfizer SLUAbstract Introduction In ORAL Surveillance, incidence rates (IRs) of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) in cardiovascular (CV)-risk-enriched patients with rheumatoid arthritis (RA) were numerically greater with tofacitinib in North America versus the rest of the world, due to underlying risk factors. Here, we evaluated the safety and efficacy of tofacitinib versus tumor necrosis factor inhibitors (TNFi) among patients with RA across geographical regions. Methods Patients with RA in ORAL Surveillance (NCT02092467), who were aged ≥ 50 years with ≥ 1 additional CV risk factor, received tofacitinib 5 or 10 mg twice daily or TNFi; 45.9% were from either Poland or North America. This post hoc analysis stratified patients by region (Poland, North America, Other countries). Efficacy endpoints included Clinical Disease Activity Index, Disease Activity Score in 28 joints, with C-reactive protein (DAS28-4[CRP]), and Health Assessment Questionnaire-Disability Index (HAQ-DI). IRs and hazard ratios for adverse events were reported. Results Of 4362 patients (Poland, N = 759; North America, N = 1243; Other countries, N = 2360), more patients from North America versus Poland/Other countries had CV risk factors such as body mass index ≥ 30 kg/m2 and history of diabetes/hypertension; however, more patients from Poland versus other regions were ever smokers and more patients from Poland/North America versus Other countries had history of coronary artery disease. MACE IRs were similar in North America and Poland, and numerically higher versus Other countries. IRs for malignancies (excluding NMSC) were numerically higher in North America versus Poland/Other countries with tofacitinib. Serious infections IRs were numerically higher in North America versus Poland across treatments. Venous thromboembolism/all-cause mortality IRs were generally comparable across regions. DAS28-4(CRP)/HAQ-DI improvements were generally lowest in North America. Conclusions Differences in safety outcomes were driven by the presence of baseline risk factors; North America and Poland demonstrated a higher proportion of patients with some baseline CV risk factors/comorbidities versus Other countries. Trial Registration NCT02092467 (ClinicalTrials.gov).https://doi.org/10.1007/s40744-024-00693-yAntirheumatic agentsCardiovascular diseasesEfficacyNorth AmericaPolandRheumatoid arthritis |
| spellingShingle | Bogdan Batko Slawomir Jeka Piotr Wiland Agnieszka Zielińska Maria Stopińska-Polaszewska Marcin Stajszczyk Magdalena Kosydar-Piechna Mary Jane Cadatal Jose L. Rivas Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance Rheumatology and Therapy Antirheumatic agents Cardiovascular diseases Efficacy North America Poland Rheumatoid arthritis |
| title | Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance |
| title_full | Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance |
| title_fullStr | Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance |
| title_full_unstemmed | Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance |
| title_short | Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance |
| title_sort | geographical differences in the safety and efficacy of tofacitinib versus tnfi a post hoc analysis of oral surveillance |
| topic | Antirheumatic agents Cardiovascular diseases Efficacy North America Poland Rheumatoid arthritis |
| url | https://doi.org/10.1007/s40744-024-00693-y |
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