Methotrexate has long been the preferred first-line therapy for rheumatoid arthritis (RA), but it doesn’t work for everyone. If you’re among those who don’t respond well to it, your doctor might suggest switching to a biologic drug or adding one to your regimen. While there are many options to choose from, you now have a brand-new one to consider. The FDA just approved upadacitinib (Rinvoq) for adults with moderate to severe RA who can’t tolerate methotrexate or don’t respond sufficiently to it.
Last year, a phase 3 study found that more than 35 percent of RA patients who took upadacitinib reached remission within 12 weeks; 14 percent of those who took methotrexate instead reached remission during the same timeframe. Other research has suggested that upadactinib may be more effective than adalimumab (Humira). (Both upadacitinib and adalimumab are made by the biopharmaceutical company AbbVie.)
Thanks to these findings, the FDA granted “Priority Review” status to upadacitinib in March 2019, which sped up the review process.
Upadacitinib is now the third JAK inhibitor that the FDA has approved for RA. It joins tofacitinib (Xeljanz) and baricitinib (Olumiant). Other drugs in this class, including filgotinib, are currently being investigated.
JAK inhibitors work by targeting the Janus kinase pathway. JAK inhibitor drugs block specific enzymes — Janus kinases — that would otherwise lead to inflammation and cause the immune system to overreact in people with RA. Unlike other types of targeted RA medications — such as tumor necrosis factor (TNF) and interleukin inhibitors — that need to be infused or injected, JAK inhibitors are taken orally.
Rinvoq may be used alone or taken along with methotrexate or another non-biologic disease-modifying anti-rheumatic drug (DMARD). The recommended dose is 15 milligrams daily. The medication should be available in late August 2019.
Rinvoq may cause side effects such as upper respiratory tract infections, nausea, and fever. The drug label also warns that it may increase the risk of developing serious infections (such as tuberculosis) as well as lymphoma.
All drugs have risks and side effects. If you’re thinking of trying upadacitinib — or any medication that you haven’t taken before — be sure to thoroughly review the pros and cons with your doctor first.
Rinvoq has a high list price of $59,000 a year (Humira has a list price of about $60,000 a year) though that is not what people with health insurance will pay for it out of pocket. What you pay for the drug will depend on your health insurance. According a Reuters article about the launch of the drug, AbbVie said it would offer a copay card that could reduce out-of-pocket costs to $5 per month for those eligible, as well as a patient support program.
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