Systematic Review of Real-World Data: Assessing Cancer, Major Adverse Cardiovascular Events, Venous Thromboembolism, Infection, and Mortality Risk Associated With Jak Inhibitors in Rheumatoid Arthritis Patients in the United States

Speaker(s)

Bazzazzadehgan S1, Gandy C2, Bruera S3, Huang Y1
1Department of Pharmacy Administration, University of Mississippi School of Pharmacy, Oxford, MS, USA, 2University of Mississippi School of Pharmacy, University, MS, USA, 3Section of Immunology, Allergy and Rheumatology, Department of Medicine, Baylor College of Medicine, Houston, TX, USA

OBJECTIVES: Janus kinase inhibitors (JAKi) are novel therapy option for rheumatoid arthritis (RA). However, data from the randomized controlled trials found major safety issues with JAKi. It is essential to complete the body of evidence with real-world data (RWD). In this review the safety of JAKi in RA patients based on RWD were summarized.

METHODS: PubMed, Ebsco, and CINAHL were searched to identify US-based studies evaluating the safety of JAKi in RA patient based on RWD. Only studies evaluating JAKi with an active comparator were included. Included safety outcomes were cancer, major adverse cardiovascular events (MACE), venous thromboembolism (VTE), infection, and mortality. Newcastle-Ottawa Scale (NOS) was utilized for the quality assessment.

RESULTS: Of 1237 citations reviewed, 25 studies met inclusion criteria. Among 8 studies evaluating the risk of cancer, while 2 of them showed no increased risk of cancer compared with bDMARDs (aHR range 0.64-1.58), one study reported an increased risk compared with csDMARDs (aHR: 4.36). Among 8 studies assessing the risk of MACE, 4 of them showed no increased risk versus bDMARDs (aHR range 0.34-1.71) or csDMARDs (aHR range 0.03-2.38). Among 7 studies evaluating VTE risk, 2 of them showed no increased risk of VTE compared with TNFi (aHR range 0.12-3.18). Among 16 studies assessing infection risk, 5 studies showed increased risk compared with bDMARDs (aHR range 0.12-3.18), and 3 studies showed no difference (aHR range 0.12-3.18). Among 4 studies evaluating mortality risk, JAKi, didn’t increase risk of mortality compared with bDMARDs (aHR range 0.59-1.68) in 4 of them. 11 of 13 full-text articles included for quality assessment, got total number of stars based NOS.

CONCLUSIONS: Many RWD-based comparative safety studies explored various safety measures for JAKi in RA. Overall, a majority of studies showed that JAKi are safer than most comparators. Additional pharmacovigilance investigations are required, for quantitative meta-analysis.

Code

EPH43

Topic

Clinical Outcomes, Epidemiology & Public Health, Study Approaches

Topic Subcategory

Clinical Outcomes Assessment, Literature Review & Synthesis, Safety & Pharmacoepidemiology

Disease

Drugs, Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)