Upadacitinib improves clinical outcomes of patients with rheumatoid arthritis

This study investigated the safety and effectiveness of upadacitinib (Rinvoq) in patients with rheumatoid arthritis (RA) who progressed after methotrexate (Otrexup). Researchers suggested that upadacitinib improved clinical and functional outcomes in these patients.

RA is an autoimmune disorder which occurs when the immune system attacks healthy cells. This leads to inflammation of the joints. The symptoms are pain, swelling, and stiffness.

There is no known cure for RA so the treatment goal is control of inflammation. A standard first-line treatment for this is methotrexate. However, two-thirds of these patients do not have a satisfactory response to this therapy, also due to its toxicity.

Prior studies suggested that upadacitinib is associated with a rapid action in patients who progressed with methotrexate. This drug stops the protein JAK from starting inflammation in the body. The safety and effectiveness of this drug alone in patients with RA are not fully known.

This study included information about 648 patients with RA. All patients had poor responses with methotrexate. These patients were assigned to receive either methotrexate (group 1), upadacitinib 15 mg (group 2) or upadacitinib 30 mg (group 3). After week 14, patients assigned to group 1, switched to upadacitinib once daily.

At week 14 response was achieved by 89 (41%) of 216 patients in group 1. 147 (68%) of 217 patients in group 2 and 153 (71%) of 215 patients in group 3 achieved a response at week 14. The C-reactive protein in the blood (present when there is inflammation in the body) was used to assess disease control. A C-reactive protein of 3.2 or lower represents a low disease activity. This was achieved by 42 (19%) of patients in group 1, by 97 (45%) in group 2 and by 114 (53%) in group 3.  

Side effects were reported in 47% of patients from group 1, in 47% of group 2 and 49% of group 3. Herpes zoster infection was reported in 1 patient from group 1, in 3 from group 2 and in 6 from group 3. One cancer was reported in group 1 and 2 in group 2. Heart disease and lung disease were also reported. One death in group 2 was reported.

This study concluded that upadacitinib is associated with improved clinical and functional outcomes in patients with RA, with similar side effects as methotrexate.  

This study included a short follow-up time of 14 weeks. The cancers were reported in patients older than 60 years and the heart and lung problems in patients with known risk factors. More research is needed regarding the safety of this treatment.

This study was funded by AbbVie, the manufacturer of upadacitinib.