AbbVie's Oral JAK1 Inhibitor Rinvoq (Upadacitinib) Succeeds in Phase 3 Program for Axial Spondyloarthritis

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News on June 2, 2022 /BioValleyBIOON/ -- AbbVie Inc. recently announcedOral Anti-Inflammatory Drug JAK1 Inhibitor Rinvoq(Rinvoq®, upadacitinib) Phase 3 SELECT-AXIS 2 program two studies (Study 1: SELECT-AXIS 2 AS bDMARD-IR; Study 2: SELECT-AXIS 2 nr-axSpA) full results. Study 1 in patients with inadequate response to biologic disease-modifying antirheumatic drugs (bDMARD) treatment refractoryActive Ankylosing Spondylitis (AS)Conducted in adult patients, Study 2 in activeRadiographic Negative Axial Spondyloarthritis (nr-axSpA)Conducted in adult patients.

The results showed,Both studies achieved the primary endpoint of ASAS40 (Assessment of SpondyloArthritis international Society 40% improvement) at Week 14.In two studies, at week 14 of treatment, compared with the placebo group,Patients in the Rinvoq treatment group showed improvements in disease symptoms and signs, pain, function, disease activity, and health-related outcomes.Quality of LifeSignificant improvements were observed in both MRI-detected SI joint inflammation (in nr-axSpA patients) and MRI-detected spinal inflammation (in AS patients).The safety data are consistent with the known safety profile of Rinvoq, with no new safety risks observed.

Rinvoq is an oral, once-daily, selective, reversible JAK inhibitor being developed for the treatment of multiple...ImmunityMediated inflammatory diseases. Rinvoq was first approved in 2019 and has now been approved for five therapeutic indications in the fields of gastroenterology, dermatology, and rheumatology.

SELECT-AXIS 2 nr-axSpA Study Results Show:At week 14 of treatment, the proportion of patients in the Rinvoq group achieving an ASAS40 response (40% improvement according to the Assessment of SpondyloArthritis International Society) was significantly higher compared to the placebo group (45% vs 23%; p<0.0001).. In addition, at week 14, compared with the placebo group, the Rinvoq treatment groupThe first 12 of the 14 multiplicity-controlled secondary endpoints also haveStatisticsStatistical Significance, including Patient's Assessment of Total Back Pain, Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity, Ankylosing Spondylitis Quality of Life (ASQoL), and the change from baseline in the Canadian Spondyloarthritis Research Consortium (SPARCC) SI joint MRI score.

SELECT-AXIS 2 AS bDMARD IR Study Results Show:At week 14 of treatment, the proportion of patients in the Rinvoq group achieving an ASAS40 response was significantly higher compared to the placebo group (45% vs 18%; p<0.0001).In addition, at Week 14, compared with the placebo group, the Rinvoq treatment groupAll multiplicity-controlled secondary endpoints were also statistically significant., including patient global back pain assessment, BASFI, ASDAS low disease activity, ASQoL, and changes in spinal MRI SPARCC score relative to baseline.

In two studies, no new safety risks of Rinvoq were identified. During the 1-14 week period of the SELECT-AXIS 2 nr-axSpA study, the proportion of patients experiencing adverse events (AE) was similar in the two treatment groups (48% in the Rinvoq group and 46% in the placebo group), with four cases of serious adverse events reported in the Rinvoq group and two in the placebo group. During the 1-14 week period of the SELECT-AXIS 2 AS bDMARD IR study, the proportion of patients experiencing adverse events was also similar in the two treatment groups (41% in the Rinvoq group and 37% in the placebo group). In both studies, no cases of malignancy or major adverse cardiac events were reported among patients treated with Rinvoq.Blood VesselAdverse Event, IntravenousThrombusEmbolism or death.

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease that affects the spine, causing back pain, restricted mobility, and structural damage.Axial spondyloarthritis (axSpA) is clinically defined as consisting of two subgroups: radiographic axial spondyloarthritis (r-axSpA, also known as "ankylosing spondylitis (AS)") and non-radiographic axial spondyloarthritis (nr-axSpA).In AS, there is clear structural damage to the sacroiliac joints (SI) visible on X-ray. In nr-axSpA, there is no definitive X-ray evidence of sacroiliac joint (SI) structural damage on X-ray. Both AS and nr-axSpA have a similar burden of symptoms, including night pain, fatigue, morning stiffness, and functional disability.

The active pharmaceutical ingredient in Rinvoq is upadacitinib, an orally administered, selective and reversible JAK1 inhibitor discovered and developed by AbbVie. It is being developed for the treatment of several immune-mediated inflammatory diseases. JAK1 is a kinase that plays a crucial role in the pathophysiological processes of various inflammatory diseases.

As of now, Rinvoq has been approved for 5 indications in the United States: moderate to severeRheumatoid Arthritis(RA, adults), active psoriatic arthritis (PsA, adults), active ankylosing spondylitis (AS, adults), moderate to severeUlcerative Colitis(UC, adults), moderate to severe atopic dermatitis (AD, ≥12 years)ChildrenAnd adults). Rinvoq has been approved in the EU for four indications: moderate to severe RA (adults), active PsA (adults), active AS (adults), and moderate to severe AD (children aged ≥12 years and adults).

In China, in February 2022, the National Medical Products AdministrationManagementThe National Medical Products Administration (NMPA) has approved Rinvoq (Rui Fu®, upadacitinib extended-release tablets) for the treatment of refractory, moderate to severe atopic dermatitis (AD) in adults and children aged 12 years and older. This approval marks the first indication for Rinvoq in China.

Rinvoq (瑞福®, Upadacitinib Extended-Release Tablets) is the first oral selective JAK inhibitor approved in China for the treatment of atopic dermatitis, ushering in a new era of oral targeted therapy for atopic dermatitis in China. With global synchronization, it brings a new treatment option to Chinese patients. In August 2021 and January 2022, Rinvoq was approved for the indication of atopic dermatitis in the EU and the US, respectively. (Bioon.com)

Source of the original text:AbbVie Presents Positive Results from Phase 3 SELECT-AXIS 2 Trials of Upadacitinib (RINVOQ®) in Patients with Axial Spondyloarthritis at EULAR 2022