December 2022

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.

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November 2022

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.

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October 2022

Risk of MACE with Tofacitinib Versus TNFi in Patients with RA With or Without a History of Atherosclerotic CV: A Post Hoc Analysis from ORAL Surveillance

Ann Rheum Dis. 2022. doi: 10.1136/ard-2022-222259

Post hoc analysis from ORAL Surveillance observes higher major adverse cardiovascular events (MACE) risk with tofacitinib vs TNFi in patients with RA and history of atherosclerotic cardiovascular disease (ASCVD).

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May 2022

Risk of major adverse cardiovascular events in patients initiating biologics/apremilast for psoriatic arthritis: a nationwide cohort study

doi: 10.1093/rheumatology/keab522

Pina Vegas and her colleagues sought to assess the relative risk of MACEs in patients with PsA initiating bDMARDs or apremilast. They found that overall, the data produced overall a positive picture regarding the incidence of MACE in treatment.

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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

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February 2022

Cardiovascular and Cancer Risk With Tofacitinib in Rheumatoid Arthritis

N Engl J Med 2022;386:316–26. doi: 10.1056/NEJMc2202778

In this paper, Ytterberg et al. compare incidence of MACE and cancers (excluding NMSC) with tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi. They found that risk of MACE and cancer were higher with tofacitinib versus TNFi, and did not meet noninferiority criteria.This prospective head-to-head safety trial compared tofacitinib to TNFi, and was required by the FDA after increases in lipid levels and cancers were observed during tofacitinib drug development. ...

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November 2021

Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221276.

Analysis of data from the highest level of patient exposure to baricitinib across the spectrum of the RA population demonstrates that baricitinib maintained a similar safety profile to earlier analyses, with no new safety signals identified.Using integrated data from nine randomised controlled trials, Taylor, et al. assessed the safety of baricitinib 2 mg and 4 mg once-daily. Analysis of data from 3770 patients (median 4.6 years, up to 9.3 years) with active RA showed that baricitinib maintained...

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July 2021

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):903–919

Fifty-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...

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March 2021

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...

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February 2021

Upadacitinib Monotherapy Versus Methotrexate Monotherapy in Methotrexate-naïve Japanese Patients with Rheumatoid Arthritis: A Sub-analysis of The Phase 3 SELECT-EARLY study

Mod Rheumatol 2021;26:1–16.

In this sub-analysis of the Phase 3 SELECT-EARLY study, UPA demonstrated clinical efficacy superior to placebo in the Japanese subpopulation. Along with a favourable efficacy observed with the Japan-specific 7.5 mg dose of UPA for all secondary endpoints. SELECT-EARLY was designed to study the safety and efficacy of UPA 15 and 30mg as monotherapy, but it also included a subset of 138 Japanese patients, 40% of whom were randomised to receive UPA 7.5mg. This was designed to meet the requirements o...

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