Baricitinib Disease Interactions

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in rheumatoid arthritis patients receiving baricitinib; the most common serious infections reported included pneumonia, herpes zoster, and urinary tract infection. Use of baricitinib should be avoided in patients with an active, serious infection, including localized infections. The risks and benefits of treatment should be considered before starting baricitinib in patients: with chronic/recurrent infection, who have been exposed to tuberculosis, with history of serious/opportunistic infection, who have resided/traveled in areas of endemic tuberculosis/mycoses, with underlying conditions that may predispose them to infection (e.g., diabetes, chronic lung disease, HIV, weak immune system), or with COVID-19 plus other concomitant infections. During and after baricitinib treatment, patients with rheumatoid arthritis or alopecia areata should be closely monitored for signs/symptoms of infection and patients with COVID-19 should be monitored for signs/symptoms of new infections.

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Baricitinib should not be given to patients with active tuberculosis (TB); patients should be evaluated for active infection before administering this agent. Patients with rheumatoid arthritis or alopecia areata should be tested for latent TB; if positive, patients should be treated with standard antimycobacterial therapy before starting baricitinib. Anti-TB therapy should be considered prior to initiating treatment with baricitinib in patients with history of latent/active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient. During baricitinib use, patients should be monitored for signs/symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.

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In a major safety study of a Janus kinase (JAK) inhibitor, tofacitinib, in rheumatoid arthritis patients 50 years and older with at least 1 cardiovascular risk factor, higher rates of all-cause mortality (including sudden cardiovascular death) and major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) were observed with the JAK inhibitor when compared with tumor necrosis factor (TNF) blockers. Patients who were current or past smokers had an additional increased risk. Based on a shared mechanism of action, this risk should be considered for other JAK inhibitors, including baricitinib, upadacitinib, ruxolitinib, fedratinib, ritlecitinib, deuruxolitinib, and pacritinib. Consider the benefits and risks for each individual patient prior and during treatment with JAK inhibitors, especially in patients with other cardiovascular risk factors, history of cardiovascular events, and patients who are current or past smokers. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur.

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Malignancies (including lymphomas and solid tumors) have been reported in patients treated with tofacitinib, baricitinib, upadacitinib, deuruxolitinib and other Janus kinase (JAK) inhibitors used to treat inflammatory conditions. Patients who are current or past smokers are at additional increased risk of malignancies. Based on a shared mechanism of action, this risk should be considered for other JAK inhibitors, including ruxolitinib, pacritinib, and fedratinib. Before starting or continuing therapy, the benefits and risks for the individual patient should be considered, especially in patients with a known malignancy (other than successfully treated nonmelanoma skin cancer), patients who develop a malignancy during therapy, and patients who are current or past smokers. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

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Thrombosis (including deep venous thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, and arterial thrombosis) has occurred in patients treated for inflammatory conditions with Janus kinase (JAK) inhibitors, including baricitinib, tofacitinib, deuruxolitinib and upadacitinib. Many of these adverse events were serious and some resulted in death. Based on a shared mechanism of action, this risk should be considered for other JAK inhibitors, including ruxolitinib, fedratinib, and pacritinib. In general, JAK inhibitors should be avoided in patients who may be at increased risk of thrombosis. Tofacitinib should be used at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response when treating ulcerative colitis. If symptoms of thrombosis occur in any patients receiving JAK inhibitors, treatment should be discontinued and patients should be evaluated promptly and treated appropriately.

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Baricitinib may cause gastrointestinal perforation. Baricitinib-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with history of diverticulitis) should be monitored. Patients presenting with new onset abdominal symptoms should be evaluated promptly for early identification of gastrointestinal perforation. Caution is recommended for patients who may be at increased risk.

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Baricitinib is not recommended in patients with rheumatoid arthritis or alopecia areata with severe liver dysfunction; baricitinib should only be used in patients with coronavirus disease 2019 (COVID-19) and severe liver dysfunction if the potential benefit outweighs the potential risk. No dose adjustment is necessary in patients with mild or moderate liver dysfunction. Treatment with baricitinib was associated with increased incidence of liver enzyme elevation compared to placebo. Liver enzymes should be evaluated at baseline and thereafter according to routine patient management; prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, baricitinib should be interrupted until this diagnosis is excluded.

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Treatment with baricitinib was associated with an increased incidence of neutropenia, lymphopenia, and anemia compared to placebo. Therapy should not be started or should be interrupted in patients with rheumatoid arthritis or alopecia areata with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL; therapy should not be started or should be interrupted in patients with coronavirus disease 2019 (COVID-19) with an ALC less than 200 cells/mm3 or ANC less than 500 cells/mm3. Evaluation at baseline and thereafter according to routine patient management is recommended; dosing should be modified based on ALC, ANC, and/or hemoglobin levels. Caution is recommended in patients who may be at increased risk.

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Renal function significantly affects baricitinib exposure; renal elimination is the principal clearance mechanism for baricitinib through filtration and active secretion. Baricitinib is not recommended in patients with rheumatoid arthritis or alopecia areata and severe renal dysfunction (estimated GFR [eGFR] less than 30 mL/min/1.73 m2); baricitinib is not recommended in patients with coronavirus disease 2019 (COVID-19) who are on dialysis, have ESRD, or have acute kidney injury (eGFR less than 15 mL/min/1.73 m2). Dosage modifications are recommended for patients with rheumatoid arthritis or alopecia areata with moderate renal dysfunction (eGFR 30 to less than 60 mL/min/1.73 m2) and COVID-19 patients with moderate or severe renal dysfunction (eGFR 15 to less than 60 mL/min/1.73 m2); care should be exercised when using this agent in such patients.

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Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical studies with baricitinib. Patients should be screened for viral hepatitis in accordance with clinical guidelines before starting therapy with baricitinib. If a patient develops herpes zoster during therapy, treatment with baricitinib should be interrupted until the episode resolves.

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