TABLE 1

Summary of relevant licensed JAK inhibitors and thrombotic concerns

JAK inhibitor and selectivityPharmaceutical CompanyLicensed indicationNotes regarding thrombosisTrials in COVID-19
N=27 as of 18th May 2020
JAK 1/2BaricitinibEli LillyRheumatoid arthritis

  • August 2017: SmPC revised to include a warning of reports of DVT and PE in patients receiving baricitinib and advised caution for use in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of these disorders, recent surgery or immobilisation

  • April 2018: FDA black-box warning for DVT PE, 2 mg OD approved (not 4 mg OD), due to thrombotic concerns

N=11
NCT04340232;
NCT04362943;
NCT04346147;
NCT04358614;
NCT04390464;
NCT04320277;
NCT04373044;
NCT04321993;
NCT04345289;
NCT04365764;
NCT04366206
RuxolitinibNovartisMyelofibrosis; Polycythaemia

  • No safety alert for thrombosis

N=14
NCT04348071
NCT04355793
NCT04354714
NCT04362137
NCT04377620
NCT04334044
NCT04337359
NCT04331665
NCT04366232
NCT04374149
NCT04361903
NCT04338958
NCT04348695
NCT04359290
JAK 1/3TofacitinibPfizerRheumatoid arthritis; Psoriatic arthritis; Ulcerative Colitis

  • February 2019: FDA issued safety alert concerning thrombotic risk

  • July 2019: FDA black-box warning for DVT and PE, for the 10 mg BD dose (this higher dose is approved for ulcerative colitis)

  • November 2019: EMA updated European product information with warning for thrombosis

N=2
NCT04390061
NCT04332042
JAK1UpadacitinibAbbvieRheumatoid arthritis

  • August 2019: FDA black-box warning for DVT, PE and arterial thrombosis

None
JAK2FedratinibCelgeneMyelofibrosis

  • No safety alert for thrombosis

None

Summary of JAK inhibitor by selectivity, licensed indications, regulatory alerts regarding thrombosis and current trials in COVID-19. It is not clear if these trials excluded patients at risk of thrombosis or mandated thromboprophylaxis.

SmPC: summary of medicinal product characteristics; FDA: Food and Drug Administration; DVT: deep venous thrombosis; PE: pulmonary emboli; OD: once daily; BD twice daily.