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Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: a post-hoc analysis of the ASTERA study


1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

 

  1. North-Western State Medical University, St. Petersburg, Russia.
  2. VA Nasonova Research Institute of Rheumatology, Moscow, Russia.
  3. VA Nasonova Research Institute of Rheumatology, Moscow, Russia.
  4. Kazan State Medical University, Kazan, Russia.
  5. Belarusian State Medical University, Minsk, Belarus.
  6. Belarusian Medical Academy of Post-graduate Education, Minsk, Belarus.
  7. VA Nasonova Research Institute of Rheumatology, Moscow, Russia.
  8. JSC BIOCAD, St. Petersburg, Russia.
  9. JSC BIOCAD, St. Petersburg, Russia.
  10. JSC BIOCAD, St. Petersburg, Russia. morozovama@biocad.ru
  11. North-Western State Medical University, St. Petersburg, Russia.

CER15564
2023 Vol.41, N°3
PI 0718, PF 0726
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PMID: 36062743 [PubMed]

Received: 08/02/2022
Accepted : 27/06/2022
In Press: 31/08/2022
Published: 23/03/2023

Abstract

OBJECTIVES:
Netakimab is a humanised camelid-derived monoclonal antibody targeting interleukin-17A. Here, we report the results of post-hoc analysis of the ASTERA phase 3 study (NCT03447704, February 27, 2018) in patients with active radiographic axial spondyloarthritis (r-axSpA) grouped by baseline C-reactive protein (CRP), baseline sacroiliac joint (SIJ) inflammation through magnetic resonance imaging (MRI) or presence of peripheral arthritis (PA).
METHODS:
In this double-blinded, multicentre, randomised, placebo-controlled, phase 3 ASTERA study, 228 adult patients with active r-axSpA received 120 mg of subcutaneous netakimab or placebo at weeks 0, 1, 2, and thereafter every other week. For the subanalysis, 16-week data of 114 netakimab-treated patients with the available baseline CRP and SIJ MRI were grouped by normal (<5 mg/L) or abnormal (≥5 mg/L) CRP, by the grade of sacroiliitis (SI) based on the SPARCC MRI score <2 (MRI-SI−) or ≥2 (MRI-SI+), or by the presence of PA. ASAS-recommended activity, spinal mobility, and function endpoints for r-axSpA were analysed.
RESULTS:
At week 16, an improvement in all the outcomes was similar for MRI-SI− and MRI-SI+ patients, except for a change in ASspi-MRI-a which was significantly greater in MRI-SI+. Netakimab was effective regardless of baseline CRP and PA. For patients with CRP ≥5 mg/L, a more pronounced decline in r-axSpA activity was observed with a trend towards the most prominent improvement in ASDAS-CRP and BASDAI for patients with CRP >20 mg/L.
CONCLUSIONS:
Subcutaneous netakimab is effective in patients with r-axSpA irrespective of baseline CRP and inflammation on SIJ MRI. The benefit in patients with high CRP (>20 mg/L) was more pronounced.

DOI: https://doi.org/10.55563/clinexprheumatol/ljpqqe

Rheumatology Article