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Efficacy and safety of Upadacitinib for active ankylosing spondylitis refractory to biological therapy


The objective of the study was to evaluate the efficacy and safety of Upadacitinib ( Rinvoq ), a Janus kinase inhibitor ( JAK ), in patients with active ankylosing spondylitis with an inadequate response to biological disease-modifying antirheumatic drugs ( bDMARDs ).

Adults with active ankylosing spondylitis who met modified New York criteria and had an inadequate response to one or two bDMARDs ( tumour necrosis factor [ TNF ] or interleukin-17 [ IL-17 ] inhibitors ) were randomised 1:1 to oral Upadacitinib 15 mg once daily or placebo.

The primary endpoint was ASAS40 ( Assessment of SpondyloArthritis international Society 40 ) response at week 14.
Sequentially tested secondary endpoints included ASDAS ( Ankylosing Spondylitis Disease Activity Score ), SPARCC ( Spondyloarthritis Research Consortium of Canada ) MRI spine inflammation score, total back pain, nocturnal back pain, BASFI ( Bath Ankylosing Spondylitis Functional Index ), BASMI ( Bath Ankylosing Spondylitis Metrology Index ) and MASES ( Maastricht Ankylosing Spondylitis Enthesitis Score ).
Results are reported from the 14-week double-blind treatment period.

A total of 420 patients with active AS were randomised ( Upadacitinib 15 mg, n=211; placebo, n=209 ).

Significantly more patients achieved the primary endpoint of ASAS40 at week 14 with Upadacitinib versus placebo ( 45% vs 18%; p less than 0.0001 ).

Statistically significant improvements were observed with Upadacitinib vs placebo for all multiplicity-controlled secondary endpoints ( p less than 0.0001 ).

Adverse events were reported for 41% of Upadacitinib-treated and 37% of placebo-treated patients through week 14.
No events of malignancy, major adverse cardiovascular events, venous thromboembolism or deaths were reported with Upadacitinib.

In conclusion, Upadacitinib 15 mg was significantly more effective than placebo over 14 weeks of treatment in bDMARD-IR patients with active ankylosing spondylitis.
No new safety risks were identified with Upadacitinib. ( Xagena )

van der Heijde D et al, Ann Rheum Dis 2022; 81: 1515-1523

XagenaMedicina_2022



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