ACR 2020 | Daily Highlights

Upadacitinib

EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: 1-YEAR RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH OPEN-LABEL EXTENSION

Abstract: 2023
Authors: Atul Deodhar et al.

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Key content:
SELECT-AXIS1 is a randomized controlled study of Upadacitinib (UPA) vs placebo in patients with active ankylosing spondylitis (AS). The results of week 14 outcomes have been presented previously, this manuscript reports data of the open label extension until week 64. The data shows that in UPA treated patients the therapy response was maintained over time with 85% of patients reaching ASAS40 at 64wk. Similar ASAS40 responses at 64wk with 81% were seen in patients switched from placebo to UPA after 14wk. In the safety analysis no serious infections, no venous thromboembolic event and no major cardiovascular events were reported. 5 Herpes zoster cases (2.1 per 100PY) were non-serious, limited to one dermatome.

Relevance:
This study confirms the results of the primary analysis of a randomized controlled study of UPA in AS. Importantly, the response rate increased over time, reaching a high percentage of ASAS40 response. The safety profile was as previously reported with UPA, in particular no cases of thromboembolic events. This study contributes to establishing JAK inhibitors as efficacious treatment option in axial spondyloarthritis.

Zusammenfassung und Kommentar von:
Prof. Dr. Diego Kyburz
Basel