Remarks

• The panel acknowledged that given that the clinical trials were not representative of the global population and that the risk-benefit may be less advantageous, particularly in areas where certain infectious diseases such as HIV infections, tuberculosis and certain fungal infections are endemic or in patients with an increased risk of opportunistic infections.
• The panel anticipated that there would be situations where clinicians may opt for less aggressive immunosuppressive therapy and/or to combine medications in a stepwise fashion in patients who are deteriorating.
• None of the included RCTs enrolled children, and therefore the applicability of this recommendation to children remains uncertain.

Practical info Additional considerations are available in a summary of practical issues. Useful information can also be found in the United States Food and Drug Administration (FDA) fact sheet for health care providers, based on the emergency use authorization (EUA) of baricitinib [99]. Here follows a brief summary of key points: Route, dosage and duration:

• The recommended dose is 4 mg daily orally in adults with eGFR ≥ 60 mL/min/1.73 m2 .
• A duration of 14 days´ treatment or until hospital discharge, whichever is first. The optimal duration of treatment is unknown, and the proposed duration reflects what was used in the trials providing evidence on treatment effects of baricitinib. Dose regimen adjustment:
• Patients with leukopenia, renal impairment or hepatic impairment (note: these parameters should be monitored during treatment).
• Patients taking strong organic anion transporter 3 (OAT3) inhibitors (e.g. probenecid), there are drug interactions which warrant dose reductions. Timing: Baricitinib (like IL-6 receptor blockers) should be initiated at the same time as systemic corticosteroids; specific timing during hospitalization or the course of illness is not specified.