Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications
Adv Ther. 2023:1–17 doi: 10.1007/s12325-023-02445-w Epub ahead of print
Analysis of pooled data from the baricitinib clinical development programmes finds a low incidence rate of MACE, myocardial infarction, lung cancer, VTE, and overall mortality in patients <65 years without risk factors.
Biomarkers to predict risk of venous thromboembolism in patients with rheumatoid arthritis receiving tofacitinib or tumour necrosis factor inhibitors
RMD Open. 2022;8(2):e002571 doi: 10.1136/rmdopen-2022-002571
Weitz, et al. analyse 291 protein biomarkers and three genetic markers and do not identify a clear mechanistic explanation for higher rates of venous thromboembolism (VTE) with tofacitinib in the ORAL Surveillance study.
Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases
Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00505-1
Salinas, et al. evaluate baricitinib safety with respect to VTE, MACE, and serious infection relative to TNFi in patients with RA, in routine care and observe an increased risk of VTE in patients taking baricitinib, compared to TNFi.
Risk of major adverse cardiovascular and venous thromboembolism events in patients with rheumatoid arthritis exposed to JAK inhibitors versus adalimumab: a nationwide cohort study
Ann Rheum Dis. 2022. doi: 10.1136/ard-2022-222824
Real-world population study of patients with RA provides reassuring data regarding the risks of major adverse cardiovascular events (MACEs) and venous thromboembolism events (VTEs) in patients initiating a JAKinib versus adalimumab, including patients at high risk of cardiovascular diseases.
Venous Thromboembolism with JAK Inhibitors and Other Immune-Modulatory Drugs: a Swedish Comparative Safety Study Among Patients with Rheumatoid Arthritis
Ann Rheum Dis. 2022. doi: 10.1136/ard-2022-223050
Nationwide register-based study in Sweden finds that patients with RA treated with JAKinibs in routine clinical practice are at increased risk of venous thromboembolism (VTE), compared with those treated with bDMARDs, an increase numerically confined to pulmonary embolism.
Expert Opin Drug Saf. 2022. doi: 10.1080/14740338.2022.2100343
It is too early to conclude that the second-generation JAK inhibitors have a lower VTE risk and caution in patients with VTE risk factors is required.
Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials
Rheumatol Ther. 2022 doi: 10.1007/s40744-021-00410-z
Upadacitinib 15 mg once daily demonstrated a similar safety profile to adalimumab 40 mg every other week, except for higher rates of HZ and opportunistic infections with upadacitinib treatment in patients treated for PsA
Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study
Rheumatol Ther. 2021;8(2):903–919Fifty-six-week data suggest that upadacitinib could be a favourable long-term treatment option in patients with PsA who are refractory to biologic therapy.As the need for additional therapeutic agents that can effectively control disease activity continues, new data from a 56-week analysis of the oral reversible JAK1 inhibitor, upadacitinib, currently under investigation for the treatment of PsA, shows that efficacy of the drug is maintained over the duration of this study.Mease, et al. explored...
Risk of venous thromboembolism associated with tofacitinib in patients with rheumatoid arthritis: a population-based cohort study
Rheumatology (Oxford). 2021 Mar 22:keab294. Epub ahead of print. DOI: 10.1093/rheumatology/keab294A population-based cohort study of 87,653 RA patients has found no evidence for an increased risk of venous thromboembolism (VTE) for tofacitinib, versus TNFis, in patients with RA.The introduction of JAKinibs, almost a decade ago, has provided an important oral option for the treatment of RA. However, in recent years, a safety concern, relating to incidence of VTE after treatment, has emerged. Consequently, both the US and European regulatory authorities now recommend caution for use of tofacit...
Post-Approval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States–Based Rheumatoid Arthritis Registry
ACR Open Rheumatol. 2021 Feb 11.Analysis from the US Corrona RA registry has provided the longest-term real-world safety data for a JAK inhibitor to date. The analysis showed that the cohorts had similar adverse events, except for higher herpes zoster rates for tofacitinib initiators vs bDMARDs.Kremer JM, et al. analysed adult patients with RA newly initiating tofacitinib, or a bDMARD, to compare incidence rates of MACE, SIEs, HZ, malignancies and death. VTE data were also collected prospectively and assessed descriptively thr...