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FDA Approves Rinvoq for RA Treatment

The US Food and Drug Administration (FDA) has approved a new drug called Rinvoq (generic name upadacitinib) for moderately to severely active RA for those patients who have not responded well or not had any response to treatment with methotrexate (MTX-IR).1

There are multiple medications available for the treatment of rheumatoid arthritis (RA), but each drug may not work for everyone. Treatment goals for RA often include: reducing or stopping inflammation, symptom relief, prevention of joint and organ damage, improving physical functioning, and minimizing or reducing long-term complications.1 It’s important to find the right medication for each patient in order to reduce symptoms, control the disease, and provide the best quality of life possible.

Rinvoq for RA treatment

Rinvoq is a once-daily oral Janus kinase (JAK) inhibitor. JAK inhibitors block enzymes that cause inflammation called Janus kinases. It is expected to be available to patients in the US by late August 2019. Exact costs are not known yet, but there will potentially be a co-pay card and patient support program to help reduce costs. The packaging is made with RA patients in mind, with easy-to-open features like a texture on the wide cap that is easier to grip and an attached tool to help with puncturing the foil liner.

Clinical remission in study participants

The approval came after a Phase 3 program that consisted of 5 studies and 4400 patients, including those who couldn’t tolerate biologic disease-modifying anti-rheumatic drugs and those who’ve never taken methotrexate and those who did not respond to methotrexate.2 Even without methotrexate, patients taking Rinvoq achieved clinical remission and the drug also significantly inhibited radiographic progression.2 This was better than both placebo and placebo and methotrexate.

Noted side effects of Rinvoq

As with all medications, Rinvoq does have some adverse effects and warnings to take into consideration. Common side effects of the drug can include upper respiratory tract infections, nausea, cough, and pyrexia.2 Those taking the medication were also at increased risk of serious infections like tuberculosis, and invasive fungal or bacterial infections.2 Lymphoma, gastrointestinal perforations, blood clots, low white blood cell count, lipid elevations, and liver function elevations have also been seen in patients taking Rinvoq.2 Across the board with JAK inhibitors, blood clots have been an issue and possible side effect; for Rinvoq specifically, pulmonary embolism and hemorrhagic stroke are possibilities.3

Talk to your doctor first

Talk with your doctor about the risks and benefits of Rinvoq, and whether it’s appropriate for you and your medical history. If you are pregnant or want to become pregnant, make sure you tell your doctor, as this might not be the best drug for you right now.

What is rheumatoid arthritis?

Rheumatoid arthritis (RA) is a systemic autoimmune disease that occurs when the immune system attacks the body, namely joints. This creates inflammation and thickens the tissue of the joints and damages bones and connective tissue.2 If untreated, it can cause permanent bone and cartilage damage that can be very serious and significantly impair activities of daily life. There is no cure for RA, but there are treatments that can help slow progression of the disease, control inflammation, and reduce pain or discomfort to help promote easier movement.

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This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The RheumatoidArthritis.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. Rheumatoid Arthritis Treatment. Arthritis Foundation. https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. n.d. Accessed August 17, 2019.
  2. AbbVie Receives FDA Approval of RINVOQ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis. Cision PR Newswire. https://www.prnewswire.com/news-releases/abbvie-receives-fda-approval-of-rinvoq-upadacitinib-an-oral-jak-inhibitor-for-the-treatment-of-moderate-to-severe-rheumatoid-arthritis-300903053.html . Published August 16, 2019. Accessed August 17, 2019.
  3. AbbVie Scores Blockbuster Approval for RA Med Rinvoq, its Crucial Humira Follow-Up. FiercePharma. https://www.fiercepharma.com/pharma/abbvie-gets-fda-green-light-for-blockbuster-to-be-ra-med-rinvoq?mkt_tok=eyJpIjoiWWpGak5XUXpZak14WVRkbSIsInQiOiJJUVFMbVhVYTFpeEpXeGcyQTFKR0hVdmtObTRsZFN5VzNhZDlMUGVwaWg5WDFJdldRSTFKZ2hGN3NzY1BSMzVCamZoR0NkRCs2NERnWFlkOTRJQ1hmXC81ZVFaa25kd2J4ZkNSYitQS0FjXC9tSWR5ejR0ZjkrRmtiNnJGZkkxemxNIn0%3D&mrkid=93574203. Published August 16, 2019. Accessed August 17, 2019.

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