Rinvoq lowers disease activity for most nr-axSpA patients: Phase 3…

One year of treatment with Rinvoq (upadacitinib) reduced disease activity for most adults with non-radiographic axial spondyloarthritis (nr-axSpA) — an inflammatory condition related to ankylosing spondylitis (AS) — in a Phase 3 clinical trial.

“These longer-term results continue to support the favorable benefit-risk profile of [Rinvoq] once daily in patients with active nr-axSpA,” the researchers wrote.

Data were in the study, “Upadacitinib in Active Non-radiographic Axial Spondyloarthritis: 1-Year Data From a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial, published in Open Rheumatology.” The work was funded by Rinvoq’s maker, AbbVie.

Rinvoq is approved to treat active ankylosing spondylitis, nr-axSpA

AS and nr-axSpA are both forms of axial spondyloarthritis, an inflammatory form of arthritis that affects joints in the lower spine. The symptoms of AS and nr-axSpA typically overlap; AS is when joint damage is visible through X-rays and nr-axSpA when no such changes can be seen with this approach.

Rinvoq, an oral anti-inflammatory medication, was approved in the U.S. in 2022 to treat active AS and active nr-axSpA in patients who don’t respond to or can’t tolerate standard anti-inflammatory treatments. It also is approved in the European Union for these patient groups.

Approvals were based on data from a Phase 3 clinical trial called SELECT-AXIS 2 (NCT04169373) that tested Rinvoq in adults with either AS or nr-axSpA who didn’t do well on first-line treatments. Participants were randomly assigned to once daily treatment with Rinvoq (15 mg) or to a placebo tablet. The trial’s placebo-controlled phase lasted about three months for AS patients, and a full year for those with nr-axSpA.

Researchers noted that “the 1-year placebo-controlled period was incorporated into this study to meet regulatory requirements.”

The main goal was to determine if patients given Rinvoq were more likely than the placebo group to experienced at least a 40% improvement on a standardized measure of disease activity called the Assessment of Spondyloarthritis International Society response criteria (ASAS40). This measure indicates a reduction of at least 40% in three or more of four domains: patient global assessment of disease, pain, function, and inflammation.

Previously published trial results showed that Rinvoq outperformed the placebo at inducing ASAS40 in both AS and nr-axSpA patients after 14 weeks.

Nearly 63% of treated patients in trial met ASAS40 criteria at one year

Data published in 2023 showed that approximately two-thirds of AS patients who were on Rinvoq for one year achieved ASAS40. Here, researchers present one-year outcomes covering nr-axSpA patients.

A total of 313 adults with nr-axSpA participated in the trial, with 259 finishing a full year in the study. Most were female, more than 80% were white, and their mean age was in the early 40s.

After the first 14 weeks of treatment, 45% of patients on Rinvoq had met ASAS40 criteria, compared with 23% of those on the placebo. At one year, almost two-thirds (62.8%) of patients on Rinvoq had achieved ASAS40, compared with less than half of those on the placebo (42.7%).

Other measures of disease severity also generally showed more improvement with Rinvoq than with the placebo, and patients given Rinvoq were significantly more likely to report a greater easing of back pain. Measures of quality of life and overall health status also favored Rinvoq over the placebo.

“Improvements in disease activity, function, and quality of life during the 14-week double-blind controlled period were maintained or further improved through the 52-week placebo-controlled period,” the researchers wrote.

Safety-related issues were generally comparable among patients given Rinvoq or the placebo. In both groups, the most commonly reported issues were infections, with three considered serious. Herpes zoster infections (the virus that causes chickenpox and shingles) and low counts of neutrophils (a type of immune cell) were more common among patients on Rinvoq, but none led to treatment discontinuation.

Safety data are “overall consistent with the well-described safety profile of upadacitinib [Rinvoq] across various diseases,” the researchers concluded.