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Posted by on Aug 9, 2018 in Rheumatoid Arthritis | 0 comments

In a nutshell

This study investigated whether upadacitinib is a safe and effective treatment for unresponsive patients with rheumatoid arthritis (RA). They concluded that upadacitinib improved RA symptoms in combination with csDMARDs and was well tolerated. 

Some background

ne type of medication used to treat rheumatoid arthritis (RA) are synthetic DMARDs (disease-modifying anti-rheumatic drugs), or csDMARDs. These can be very effective, however, some patients with RA do not respond well to conventional treatment.

Upadacitinib is a new drug under investigation for RA treatment. It blocks a specific enzyme called Janus kinase 1 (JAK1) and reduces inflammation. It is unclear if upadacitinib is a safe and effective drug to treat RA in patients with an inadequate response to csDMARDs.

Methods & findings

This study included 661 patients with RA who were unresponsive to csDMARDs.  Patients were randomly assigned to receive 15 mg upadacitinib, 30 mg upadacitinib or placebo (inactive tablet) for 12 weeks. After this period, patients received either 15 mg or 30 mg upadacitinib for up to 5 years (this study is ongoing). At the end of 12 weeks patients were assessed at a clinic and disease activity was measured.

At 12 weeks, 65% of patients taking upadacitinib achieved a 20% improvement in disease symptoms, compared to 36% of placebo patients. 48% of upadacitinib patients achieved improved disease activity compared to 17% of placebo patients. Patients in the upadacitinib groups also reported improvements in quality of life.

Negative side effects (adverse events) were reported in all groups. The most common were nausea, headache and chest infections. A greater number of serious adverse events were reported in patients taking 15 mg upadacitinib.

The bottom line

This study concluded that upadacitinib improved RA symptoms in combination with csDMARDs and was well tolerated.

The fine print

This study looked at safety and effectiveness over a relatively short period. This trial is ongoing and it will be important to consider data on the long-term safety and effectiveness of upadacitinib when it becomes available. 

What’s next?

If you have any concerns regarding treatment for rheumatoid arthritis please discuss with your physician.

Published By :

Lancet (London, England)

Date :

Jun 12, 2018

Original Title :

Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial.

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