¹Ruhr-Universität Bochum, Bochum
²Rheumazentrum Ruhrgebiet, Herne
³Krankenhaus der Barmherzigen Brüder, Department of Rheumatology, Immunology and Nephrology, Medical Campus of the Johannes Gutenberg-University Mainz, Trier
⁴Department of Rheumatology, Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim
⁵StatConsult GmbH Biometrie und Datenmanagement, Magdeburg
⁶AbbVie Deutschland GmbH & Co. KG, Wiesbaden

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Methods: In this interim analysis alleviation of symptoms was evaluated at weeks 4 and 12 considering the following outcomes: i) ASADAS inactive disease (ID) or low disease activity (LDA) states, ii) ASAS40 response, iii) BASDAI response, and iiii) total back pain. Safety was assessed by collection of adverse event (AE) data.

Results: Mean age of 198 patients (59.6% male) was 44.3 (11.8) years, symptom duration was 13.7 (10.5) years and disease duration 9.5 (10.1) years. 39.4% of patients were bDMARD-naïve and 60.6% were bDMARD-IR. Initial ASDAS was 3.4 (0.9) for bDMARD-naïve (n = 63) and 3.2 (0.8) for bDMARD-IRs (n = 108) patients. Baseline CRP-level was 1.2 (2.2) mg/l and decreased to 0.8 (2.0) mg/dl and 0.6 (1.0) mg/dl after 4 and 12 weeks.

ASDAS-ID or ASDAS-LDA increased from 0.6% and 7.0% at baseline to 7.3% and 42.0% at week 4, and to 12.0% and 45.8% at week 12. (Figures 1a & b). 23.1% and 26.6% of all patients achieved ASAS40 at weeks 4 and 12 (Figure 1c). The average BASDAI score of 5.4 (1.9) changed to 3.7 (2.1) at week 4 and week 12, each. (Figure 1d) [1]. Alleviation of total back pain at week 4 was ∆ BL = -2.0 [95%CI: -2.4 to -1.6]) with further pain reduction by week 12 (∆ BL = -2.5 [95%CI: -2.9 to -2.0]) (Figure 1e) [2]. Outcomes for bDMARD-naïve and bDMARD-IR patients were mostly comparable (Figures 1a-e [Fig. 1]). Adverse events did not indicate any new safety signals.

Conclusion: Treatment with UPA led to meaningful improvement of axSpA symptoms demonstrated as early as week 4. Outcomes were comparable for bDMARD-naïve and bDMARD-IR patients. No new safety signals were identified.

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