The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) and tildrakizumab (Ilumya) were approved earlier.

Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is the second selective IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) was the first.

The oral sphingosine 1-phosphate (S1P) receptor modulator ozanimod (Zeposia – Bristol Myers Squibb) has been approved by the FDA for treatment of adults with moderately to severely active ulcerative colitis. It is the first S1P receptor modulator to be approved for treatment of ulcerative colitis. Ozanimod was approved in March 2020 for use in adults with relapsing forms of multiple sclerosis.

The FDA has approved the interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) for treatment of moderately to severely active ulcerative colitis (UC) in adults. Mirikizumab is the first selective IL-23 antagonist to be approved for this indication. Ustekinumab (Stelara), an IL-12/23 antagonist, was approved for treatment of UC in 2019. The IL-23 antagonist risankizumab (Skyrizi) is approved for treatment of Crohn's disease.

The May 5, 2008 article (Med Lett Drugs Ther 2008; 50:34) on the approval of natalizumab (Tysabri) for treatment of Crohn's disease in the "Adverse Effects" section on page 35 included the statement: "post-marketing hepatotoxicity, sometimes fatal or requiring liver transplantation, has occurred." Actually, no fatal hepatotoxicity or liver transplantation has been reported to date. The FDA warning about post-marketing hepatotoxicity with Tysabri that was the basis for our statement said: "The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is...

Mild to moderate plaque psoriasis can be treated with topical drugs and phototherapy. Patients with moderate to severe disease generally require systemic therapy. Guidelines for the treatment of psoriasis with topical therapy, phototherapy, and systemic drugs have recently been published.

Anakinra (Kineret - Amgen), an interleuken-1 (IL-1) receptor antagonist, has been approved by the FDA for treatment of moderately to severly active rheumatoid arthritis in adults who have failed at least one disease-modifying anti-rheumatic drug(DMARD) such as methotrexate (Medical Letter 2000; 24:57).

The FDA has approved deucravacitinib (Sotyktu – BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for once-daily treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is the first selective TYK2 inhibitor to be approved in the US for any indication.

The interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active ulcerative colitis (UC) in adults; it was approved earlier for treatment of plaque psoriasis and psoriatic arthritis. Guselkumab is the third IL-23 antagonist to be approved in the US for treatment of UC; risankizumab (Skyrizi) and mirikizumab (Omvoh) were approved earlier.

Natalizumab (Tysabri - Elan and Biogen) is a monoclonal antibody approved for induction and maintenance treatment of moderate to severe Crohn's disease (CD) refractory to conventional therapies and inhibitors of tumor necrosis factor (TNF). Initially approved in 2004 for the treatment of multiple sclerosis (MS), natalizumab was temporarily withdrawn from the market after 3 patients developed progressive multifocal leukoencephalopathy (PML). It is now available for treatment of both MS and CD through a restricted distribution program.