TY - JOUR
T1 - Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis
T2 - 12-week results from a phase III study, ULTIMATE
AU - D'Agostino, Maria Antonietta
AU - Schett, Georg
AU - López-Rdz, Alejandra
AU - Šenolt, Ladislav
AU - Fazekas, Katalin
AU - Burgos-Vargas, Ruben
AU - Maldonado-Cocco, Jose
AU - Naredo, Esperanza
AU - Carron, Philippe
AU - Duggan, Anne-Marie
AU - Goyanka, Punit
AU - Boers, Maarten
AU - Gaillez, Corine
N1 - © The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.
PY - 2022/5/1
Y1 - 2022/5/1
N2 - Objectives: To investigate the dynamics of response of synovitis to IL-17A inhibition with secukinumab in patients with active PsA using Power Doppler ultrasound. Methods: The randomized, placebo-controlled, Phase III ULTIMATE study enrolled PsA patients with active ultrasound synovitis and clinical synovitis and enthesitis having an inadequate response to conventional DMARDs and naïve to biologic DMARDs. Patients were randomly assigned to receive either weekly subcutaneous secukinumab (300 or 150 mg according to the severity of psoriasis) or placebo followed by 4-weekly dosing thereafter. The primary outcome was the mean change in the ultrasound Global EULAR and OMERACT Synovitis Score (GLOESS) from baseline to week 12. Key secondary endpoints included ACR 20 and 50 responses. Results: Of the 166 patients enrolled, 97% completed 12 weeks of treatment (secukinumab, 99%; placebo, 95%). The primary end point was met, and the adjusted mean change in GLOESS was higher with secukinumab than placebo [-9 (0.9) vs -6 (0.9), difference (95% CI): -3 (-6, -1); one-sided P=0.004] at week 12. The difference in GLOESS between secukinumab and placebo was significant as early as one week after initiation of treatment. All key secondary endpoints were met. No new or unexpected safety findings were reported. Conclusion: This unique ultrasound study shows that apart from improving the signs and symptoms of PsA, IL-17A inhibition with secukinumab leads to a rapid and significant reduction of synovitis in PsA patients.
AB - Objectives: To investigate the dynamics of response of synovitis to IL-17A inhibition with secukinumab in patients with active PsA using Power Doppler ultrasound. Methods: The randomized, placebo-controlled, Phase III ULTIMATE study enrolled PsA patients with active ultrasound synovitis and clinical synovitis and enthesitis having an inadequate response to conventional DMARDs and naïve to biologic DMARDs. Patients were randomly assigned to receive either weekly subcutaneous secukinumab (300 or 150 mg according to the severity of psoriasis) or placebo followed by 4-weekly dosing thereafter. The primary outcome was the mean change in the ultrasound Global EULAR and OMERACT Synovitis Score (GLOESS) from baseline to week 12. Key secondary endpoints included ACR 20 and 50 responses. Results: Of the 166 patients enrolled, 97% completed 12 weeks of treatment (secukinumab, 99%; placebo, 95%). The primary end point was met, and the adjusted mean change in GLOESS was higher with secukinumab than placebo [-9 (0.9) vs -6 (0.9), difference (95% CI): -3 (-6, -1); one-sided P=0.004] at week 12. The difference in GLOESS between secukinumab and placebo was significant as early as one week after initiation of treatment. All key secondary endpoints were met. No new or unexpected safety findings were reported. Conclusion: This unique ultrasound study shows that apart from improving the signs and symptoms of PsA, IL-17A inhibition with secukinumab leads to a rapid and significant reduction of synovitis in PsA patients.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85115835945&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/34528079
U2 - https://doi.org/10.1093/rheumatology/keab628
DO - https://doi.org/10.1093/rheumatology/keab628
M3 - Article
C2 - 34528079
SN - 1462-0324
VL - 61
SP - 1867
EP - 1876
JO - Rheumatology (Oxford, England)
JF - Rheumatology (Oxford, England)
IS - 5
ER -