Short-term Risk of Major Adverse Cardiovascular Events or Venous Thrombo-embolic Events in Patients with Rheumatoid Arthritis Initiating a Janus Kinase Inhibitor: A Meta-analysis of Randomised Controlled Trials

Margaux MALAURIE¹, Arnaud Constantin ², Yannick Degboé ¹, Adeline Ruyssen-Witrand ³ and Thomas Barnetche ⁴, ¹CHU TOULOUSE, TOULOUSE, France, ²CHU TOUOUSE, TOULOUSE, France, ³Rheumatology Unit, Toulouse university Hospital, UMR 1027, Inserm, Université Paul Sabatier Toulouse III, Toulouse, France, ⁴FHU ACRONIM, Department of Rheumatology, Centre Hospitalier Universitaire, Bordeaux, France, Bordeaux, France

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: cardiovascular disease and meta-analysis, drug safety, Janus kinase (JAK), Rheumatoid arthritis (RA)

Session Information

Date: Tuesday, November 12, 2019

Title: RA – Treatments Poster III: Safety and Outcomes

Session Type: Poster Session (Tuesday)

Session Time: 9:00AM-11:00AM

Background/Purpose: The objective was to investigate the short-term risk of major adverse cardiovascular events (MACEs) or venous thromboembolic events (VTEs) in patients with rheumatoid arhthritis (RA) initiating a Janus kinase inhibitor (JAKi).

Methods: Screening for the study was carried out using MEDLINE, Cochrane and Embase, from the inception of the database to February 2019. Randomised controlled trials (RCTs) of JAKi for the treatment of rheumatoid arthritis were included. Two investigators independently extracted MACEs or VTEs reported during the placebo-controlled phase. The primary outcome measures were the incidence of MACEs or VTEs.

Results: From 205 references screened, 26 articles were selected, and 3 articles were added by manual searches. Accordingly 30 RCTs were included in the meta-analysis. No statistically significant difference was observed in MACE (Figure 1) or VTE incidences (Figure 2) in patients receiving any of the JAKi compared to the placebo group. A numeric imbalance was observed in the baricitinib group with 7 VTEs (688 P-Y) compared with none in the placebo group (452 P-Y), with 0,01 -0,00 to 0,02 risk difference, which is not statistically significant. A numeric imbalance was also observed in the upadacitinib group with 6 VTEs (611 P-Y) compared to 1 VTE in the placebo group (440 P-Y), with 0,01 -0,00 to 0,02 risk difference, which is not statistically significant neither.

Conclusion: This MA of 30 RCTs did not reveal any statistically significant change in the short-term risk of MACEs or VTEs in patients with RA initiating a JAKi. Data from the long-term extension phases of these RCTs, from studies designed to compare JAKi to bDMARDs with respect to MACEs or VTEs and from the long-term follow-up of patients included in JAKi registries are required to further characterise the risk of MACEs or VTEs in patients with RA treated with JAKi.

MACE_JAKi vs PBO_V2

Difference in the risk of MACEs in RA patients treated with JAKi compared with the placebo in RCTs.

ETE_JAKi vs PBO_V2

Difference in the risk of VTEs in RA patients treated with JAKi compared with the placebo in RCTs.

Disclosure: M. MALAURIE, None; A. Constantin, Novartis, 8, Pfizer, 5, Sanofi, 5, SANOFI, 8, UCB, 5, 8; Y. Degboé, None; A. Ruyssen-Witrand, None; T. Barnetche, None.

To cite this abstract in AMA style:

MALAURIE M, Constantin A, Degboé Y, Ruyssen-Witrand A, Barnetche T. Short-term Risk of Major Adverse Cardiovascular Events or Venous Thrombo-embolic Events in Patients with Rheumatoid Arthritis Initiating a Janus Kinase Inhibitor: A Meta-analysis of Randomised Controlled Trials [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/short-term-risk-of-major-adverse-cardiovascular-events-or-venous-thrombo-embolic-events-in-patients-with-rheumatoid-arthritis-initiating-a-janus-kinase-inhibitor-a-meta-analysis-of-randomised-control/. Accessed .

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