Upadacitinib significantly improves non-radiographic axial SpA signs, symptoms vs placebo
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Upadacitinib demonstrated significant improvements in patients with non-radiographic axial spondyloarthritis when compared with a placebo at 14 weeks, according to data published in The Lancet.
“Upadacitinib has already shown efficacy in a phase 2/3 study in ankylosing spondylosis patients with inadequate response to NSAIDs, and in another phase 3 study in AS patients who had an inadequate response to biologic DMARDs,” Atul Deodhar, MD, of the Oregon Health & Science University, in Portland, told Healio. “We wanted to investigate its efficacy in non-radiographic axial SpA patients with evidence of active inflammation, who have equal burden of disease, but have limited FDA approved options to treat.”
To evaluate upadacitinib (Rinvoq, AbbVie) in patients with non-radiographic axial SpA, Deodhar and colleagues conducted the SELECT-AXIS 2 trial, a phase 3, randomized, double-blind, placebo-controlled, multicenter trial. The researchers enrolled adults aged 18 years or older with a confirmed diagnosis of non-radiographic axial SpA from 113 sites across 23 countries. Other inclusion criteria included active disease at screening and baseline timepoints, and one or more objective sign of active inflammation as confirmed by an MRI test. Patients were excluded if they demonstrated a lack of efficacy with TNF and interleukiun-17 inhibitors.
Patients were randomized to receive either upadacitinib 15 mg once daily or a placebo through 14 weeks. Visits and data collection were completed at baseline and weeks 1, 2, 4, 8, 12 and 14. Although most metrics were collected at every visit, Spondyloarthritis Research Consortium of Canada MRI spine and sacroiliac joint scores, as well as Bath Ankylosing Spondylitis Metrology Index, and tender and swollen joint counts, were only assessed at week 14.
The primary endpoint was the proportion of patients with an Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 14. Secondary endpoints included change from baseline in Ankylosing Spondylitis Disease Activity Score, as measured by C-reactive protein, and SPARCC MRI sacroiliac joint inflammation scores. Additionally, the authors analyzed treatment-emergent adverse events up to week 14.
The analysis included 295 patients with non-radiographic axial SpA. According to the researchers, more patients treated with upadacitinib (45%) achieved an ASAS40 response than those who received a placebo (23%), with a treatment difference of 22% (95% CI, 12% to 32%). In addition, the rate of adverse events was similar in both groups, at 48% in the upadacitinib group and 46% in the placebo group. Two patients treated with upadacitinib and one patient receiving placebo developed serious infections or herpes zoster. There were five cases of neutropenia in the upadicitinib group, compared with none in the placebo group.
“This study was successful, and upadacitinib significantly improved the signs, symptoms, serological and imaging markers of inflammation, function and quality of life in patients with non-radiographic axial SpA, compared to placebo,” Deodhar said. “If the drug gets approved, it will be the first oral advanced therapy available to treat non-radiographic axial SpA.
“One-third of patients in this study had previously been treated with biologic DMARDs, TNF inhibitors and some with IL-17 inhibitors,” he added. “The subgroup analysis showed that UPA was effective in these patients as well.”
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