The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or are intolerant of methotrexate. Ruxolitinib (Jakafi) is the only other JAK inhibitor available in the US; it is FDA-approved for treatment of myelofibrosis.

The FDA has required updates to the labeling of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz, Xeljanz XR) based on interim results of a postmarketing safety trial that showed an increased risk of pulmonary thromboembolism and death with a dosage of 10 mg twice daily.1 Tofacitinib is approved for treatment of rheumatoid arthritis (RA),2 psoriatic arthritis, and ulcerative colitis.In the postmarketing trial, RA patients ≥50 years old taking methotrexate who had at least one cardiovascular risk factor were randomized to receive add-on treatment with tofacitinib 5 mg twice daily (the...

The FDA has required updates to the boxed warnings in the labeling of the Janus kinase (JAK) inhibitors tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant), and upadacitinib (Rinvoq) describing increased risks of major adverse cardiovascular events, malignancy, thrombosis, and death with their use. The new warnings were prompted by the results of a postmarketing safety trial with tofacitinib and were added to the labels of baricitinib and upadacitinib based on the presumption of a class effect. The tofacitinib package insert had contained a boxed warning about an increased...

View the Table: Some Drug Interactions with Drugs for IBD

The FDA has approved upadacitinib (Rinvoq – Abbvie), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or cannot tolerate methotrexate (Trexall, and others). Upadacitinib is the third JAK inhibitor to be approved in the US for treatment of RA; tofacitinib (Xeljanz, Xeljanz XR) and baricitinib (Olumiant) were approved earlier.

The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

Psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis. A recent review found that about 20% of patients with psoriasis have psoriatic arthritis. Updated guidelines for treatment of psoriatic arthritis have recently been published.

Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.

The FDA has approved the Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) for oral treatment of adults with moderately to severely active rheumatoid arthritis (RA) that has not responded adequately to one or more tumor necrosis factor (TNF) inhibitors. Baricitinib is the second JAK inhibitor to be approved for treatment of RA; tofacitinib (Xeljanz, Xeljanz XR) was the first.

View Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis