medwireNews: Findings from the phase II/III SELECT-AXIS 1 trial suggest that treatment with upadacitinib may improve disease activity, function, and axial inflammation among biologic-naïve patients with ankylosing spondylitis and an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs.
Speaking to medwireNews, lead investigator Désirée van der Heijde (Leiden University Medical Center, the Netherlands) said that if these results were confirmed in phase III trials, upadacitinib “would offer a new treatment option for patients with ankylosing spondylitis.”
As reported at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, and published simultaneously in The Lancet, patients treated with the selective Janus kinase (JAK) 1 inhibitor were significantly more likely than those given placebo to achieve the primary outcome of an ASAS40 response at week 14.
This endpoint was met by 52% of the 93 patients treated with upadacitinib 15 mg/day and 26% of the 94 participants in the placebo arm. And van der Heijde noted that the onset of response to upadacitinib treatment “was rapid,” with significant differences in ASAS40 response rates between the two groups seen as early as week 2.
Furthermore, patients given upadacitinib experienced significantly greater decreases in Spondyloarthritis Research Consortium of Canada magnetic resonance imaging spine and sacroiliac joint scores, as well as ASDAS and BASFI scores, compared with those given placebo in a multiplicity-controlled analysis.
van der Heijde said that rates of adverse events were similar in the upadacitinib and placebo groups, and that “no new safety signals were observed.”
In all, 62% and 55% of patients in the upadacitinib and placebo arms, respectively, experienced adverse events, and a corresponding 2% and 3% experienced adverse events leading to treatment discontinuation. Infections occurred in 20% of patients given the JAK inhibitor and 28% of those in the placebo group.
Discussing the SELECT-AXIS 1 results in a comment accompanying the publication in The Lancet, Maria Tektonidou (Laikon Hospital, Athens, Greece) says that the “[l]ong-term efficacy of upadacitinib in patients with the full spectrum of axial spondyloarthritis (not only ankylosing spondylitis), as well as in those with an inadequate response to biological DMARDs,” should be investigated in future studies.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group
This information is brought to you by medwireNews and is not sponsored by, nor a part of, the American College of Rheumatology