Rinvoq reduces AS disease activity in 1 year of clinical trial

Improvements seen in adults who had failed to respond to other treatments

Marisa Wexler MS avatar

by Marisa Wexler MS |

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Treatment with Rinvoq (upadacitinib) substantially reduced disease activity for most adults with ankylosing spondylitis (AS) who had failed to respond to other treatments, according to one-year data from a clinical trial.

“These 1-year data demonstrated consistent improvement and maintenance of response with [Rinvoq] treatment in treatment-refractory patients with AS across a wide range of clinically relevant domains encompassing disease activity, pain, function, enthesitis [inflammation of the sites where a tendon or ligament attaches to bone], and quality of life,” the researchers wrote.

The study, “Efficacy and safety of upadacitinib in patients with ankylosing spondylitis refractory to biologic therapy: 1-year results from the open-label extension of a phase III study,” was published in Arthritis Research & Therapy.

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Rinvoq is approved in US, EU, and Canada

Rinvoq is a daily oral therapy approved in the U.S., Europe, and Canada for adults with AS for whom other therapies are either not effective or not tolerated. It works to reduce inflammation by blocking Janus kinase enzymes, a type of protein involved in the activation of inflammatory immune cells.

The Phase 3 clinical trial SELECT-AXIS 2 (NCT04169373) enrolled 420 adults with AS who had failed to respond to or been unable to tolerate other approved biological treatments for AS. Participants were given Rinvoq at 15 mg/day, or a placebo, for 14 weeks.

After the placebo-controlled part of the trial, 409 patients continued to an open-label extension, wherein all participants were treated with Rinvoq. About 90% of these patients stayed in the study for at least one year in total. Here, researchers reported on one-year data from the trial.

The main goal of SELECT-AXIS 2, which was funded by Rinvoq developer AbbVie, was to assess the number of patients who experienced at least a 40% improvement on the Assessment of Spondyloarthritis International Society (ASAS40) response criteria, which is a standardized measure of AS disease activity.

After the first 14 weeks, ASAS40 rates were significantly higher for patients given Rinvoq compared to placebo (45% vs 18%). After a year on treatment, 66% of patients given Rinvoq achieved ASAS40. For patients who switched from placebo to Rinvoq after week 14, 65% achieved ASAS40 by one year.

Other measures of AS disease activity, including back pain, nocturnal back pain, and function, mobility, inflammation of the tendons or ligaments, and quality of life, generally showed similar trends. For patients continuously on Rinvoq, improvements seen after 14 weeks were mostly maintained through the end of the study, and for patients originally given placebo, similar improvements occurred during the extension phase after switching to Rinvoq treatment. The findings were similar among patients who had stopped previous therapies due to inefficacy or tolerance issues.

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Improvements sustained through 1 year in extension study

“The responses that were observed in the initial double-blind period of the study further improved after week 14 and were sustained through 52 weeks [one year] in the open-label extension,” the researchers wrote.

Safety data from the extension study were generally consistent with earlier data on Rinvoq. The most common side effects associated with the immune-suppressing therapy were infections, including the common cold and COVID-19. Some serious infections and other serious side effects occurred, but these were generally infrequent.

“Treatment with [Rinvoq] was generally safe and well tolerated, with no new safety risks identified compared with the known safety profile,” the researchers wrote.