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FDA Approves Rinvoq for Active Psoriatic Arthritis

Posted on January 19, 2022
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Medically reviewed by
Ariel D. Teitel, M.D., M.B.A.
Article written by
Emily Wagner, M.S.

  • The U.S. Food and Drug Administration (FDA) recently approved Rinvoq (upadacitinib) for the treatment of active psoriatic arthritis (PsA) in adults who previously failed other therapies.
  • This is the third treatment approved for PsA that inhibits Janus kinase (JAK) proteins.
  • The FDA has also issued a warning for JAK inhibitors, which may cause heart-related complications and an increased rate of malignancies.

Adults living with psoriatic arthritis who have not found relief from current treatments may now have a new option. The FDA approved Rinvoq last December for the treatment of active PsA in adults who have failed previous treatment with other PsA therapies. This is the third JAK inhibitor approved for treating PsA — Xeljanz (tofacitinib) was approved in 2017 and Olumiant (baricitinib) was approved in 2018.

“Many adults still struggle to find a treatment option that helps them lower their disease activity,” said Iain McInnes, the Muirhead chair of medicine and the Versus Arthritis professor of rheumatology at Scotland’s University of Glasgow, in a press release from drug manufacturer AbbVie. “With this FDA approval, Rinvoq has the potential to help more people find meaningful relief from the signs and symptoms of psoriatic arthritis that they see and feel and to help reach their treatment goals.”

What Is Rinvoq?

Rinvoq belongs to a class of drugs known as Janus kinase inhibitors. JAK proteins are specialized proteins that send signals from the outside of cells to the inside. These proteins are often activated by inflammatory mediators known as cytokines, which play a large role in autoimmune diseases like PsA.

Inhibiting JAK proteins has been shown to be an effective treatment in other diseases such as psoriasis, rheumatoid arthritis (RA), and inflammatory bowel disease (IBD). The FDA originally approved Rinoq in August 2019 to treat moderate to severe RA in people who did not respond well to medications that block the cytokine tumor necrosis factor (TNF) alpha.

Two phase 3 clinical trials — SELECT-PsA 1 and SELECT-PsA 2 — assessed the safety and efficacy of Rinvoq in people with PsA compared to placebo. Overall, Rinvoq significantly improved physical function, skin clearing, and fatigue in people with PsA.

JAK Inhibitors for Psoriatic Arthritis

There are now a total of three approved JAK inhibitors used for treating PsA and other rheumatic diseases: Rinvoq, Xeljanz, and Olumiant. These medications differ from other disease-modifying antirheumatic drugs (DMARDs) used to treat rheumatoid arthritis and PsA, such as methotrexate or biologics.

JAK inhibitors are considered synthetic DMARDs. They are given orally, rather than being injected, which can make them favorable compared to other DMARDs. They are also targeted to inhibit specific proteins instead of broadly inhibiting the immune system like systemic DMARDs (such as methotrexate).

Rinvoq is given once daily as a 15 milligram extended-release tablet that can be taken with or without food.

Risks Associated with JAK Inhibitors

The FDA has released warnings for JAK inhibitors, which have an increased risk of causing serious heart-related and other complications such as:

  • Stroke
  • Heart attack
  • Blood clots
  • Lymphoma, skin cancer, and lung cancer
  • Death

Like other DMARDs that work by dampening the immune system, Rinvoq may also interfere with the body’s ability to fight infections.

Posted on January 19, 2022
View reactions
All updates must be accompanied by text or a picture.
Ariel D. Teitel, M.D., M.B.A. is the clinical associate professor of medicine at the NYU Langone Medical Center in New York. Review provided by VeriMed Healthcare Network. Learn more about him here.
Emily Wagner, M.S. holds a Master of Science in biomedical sciences with a focus in pharmacology. She is passionate about immunology, cancer biology, and molecular biology. Learn more about her here.

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