The FDA has approved brodalumab (Siliq – Valeant), an injectable human interleukin (IL)-17A receptor antagonist, for treatment of adults with moderate to severe plaque psoriasis who have failed to respond to other systemic therapies. Brodalumab is the third IL-17A antagonist to be approved in the US for this indication; secukinumab (Cosentyx) and ixekizumab (Taltz) were approved earlier.

Leflunomide (Arava - Hoechst Marion Roussel), which inhibits pyrimidine synthesis, and etanercept (Enbrel - Immunex/Wyeth-Ayerst), which blocks the action of tumor necrosis factor (TNF), have been approved by the FDA for treatment of rheumatoid arthritis. A third drug, infliximab (Remicade - Centocor), which also blocks TNF and has been used to treat rheumatoid arthritis, was approved earlier for treatment of Crohn's disease. Its use in Crohn's disease will be reviewed in a future issue.

The FDA has approved the use of ustekinumab (Stelara - Centocor Ortho Biotech), an interleukin antagonist given by subcutaneous (SC) injection for treatment of adults with moderate to severe plaque psoriasis. It is the first agent in its class for this indication; the other biologic agents for psoriasis are Tcell or tumor necrosis factor (TNF) inhibitors.

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.

Atacept (Orencia - Bristol-Myers Squibb), an inhibitor of T-cell activation, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA) in patients who have not responded to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Golimumab (Simponi - Centocor), a fully humanized anti-tumor necrosis factor (TNF)-a antibody, has been approved by the FDA for the treatment of: (1) moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate; (2) active psoriatic arthritis (PsA) alone or in combination with methotrexate; and (3) active ankylosing spondylitis (AS).

The FDA has approved ixekizumab (Taltz – Lilly), an injectable humanized interleukin (IL)-17A antagonist, for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ixekizumab is the second IL-17A antagonist to be approved for this indication in the US; secukinumab (Cosentyx – Novartis) was the first.

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi) for second-line treatment of adults with moderately to severely active rheumatoid arthritis (RA). It is the second IL-6 inhibitor to be approved for this indication; tocilizumab (Actemra) was approved earlier.

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

The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.