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Abstract Number: 0914

Response to Certolizumab Pegol in Patients with Non-Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Cut-Offs: Post-Hoc Analysis from a Phase 3 Multicenter Study

Philip Robinson1, Stephen Hall2, Bengt Hoepken3, Lars Bauer3, Eleni Demas4, Mindy Kim5 and Atul Deodhar6, 1University of Queensland School of Clinical Medicine, Brisbane, Queensland, Australia, Herston, Australia, 2Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, 3UCB Pharma, Monheim am Rhein, Germany, 4UCB Pharma, Slough, United Kingdom, 5UCB Pharma, Smyrna, GA, 6Oregon Health & Science University, Portland, OR

Meeting: ACR Convergence 2021

Keywords: Anti-TNF Drugs, C-reactive protein (CRP), spondyloarthritis

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Session Information

Date: Sunday, November 7, 2021

Session Title: Spondyloarthritis Including PsA – Treatment Poster I: Axial Spondyloarthritis (0908–0939)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Certolizumab pegol (CZP), an Fc-free, PEGylated tumor necrosis factor (TNF) inhibitor, has previously demonstrated efficacy and safety in patients with radiographic (r) and non-radiographic (nr) axial spondyloarthritis (axSpA).1,2 In nr-axSpA patients, CZP has demonstrated efficacy across all C‑reactive protein (CRP) subgroups, including patients with normal baseline CRP levels.3 However, the association between CZP efficacy and baseline CRP levels has not been investigated in the subset of nr-axSpA patients with positive magnetic resonance imaging (MRI+; defined as the presence of active sacroiliitis on MRI based on the Assessment of SpondyloArthritis international Society [ASAS] criteria).4 This post-hoc analysis explores the association between baseline CRP levels and CZP efficacy in MRI+ nr-axSpA patients from the C‑OPTIMISE trial.

Methods: C-OPTIMISE (NCT02505542) was a two-part, multicenter, phase 3b study in adult patients with r-axSpA or nr-axSpA.1,2 In the open-label run-in period (0–48 weeks), patients received CZP 400 mg at Weeks 0, 2, and 4, then CZP 200 mg every 2 weeks thereafter. This analysis included the subset of MRI+ nr‑axSpA patients in the C‑OPTIMISE cohort who received ≥1 dose of study medication in the open-label period. Efficacy outcomes were evaluated and stratified by baseline CRP levels ( <5 mg/L, ≥5– < 10 mg/L and ≥10 mg/L). The upper limit of normal of the CRP assay was defined as 9.99 mg/L by the central laboratory. The lower limit of quantification (LLoQ) was 4 mg/L; where CRP levels < LLoQ, a CRP value of 2 mg/L was used to calculate Ankylosing Spondylitis Disease Activity Score (ASDAS).5 Outcomes included ASAS ≥40% improvement (ASAS40), ASDAS – major improvement (ASDAS-MI), ASAS partial remission (ASAS PR), ASDAS, BASDAI, and BASFI.

Results: In total, 275 MRI+ nr-axSpA patients were included in this analysis (CRP <5 mg/L: n=156; CRP ≥5– <10 mg/L: n=38; CRP ≥10 mg/L: n=81). Response rates for ASAS40 increased over the treatment period and were comparable across CRP subgroups (Figure 1A). Response rates for ASDAS-MI were higher in the CRP ≥10 mg/L and CRP ≥5– <10 mg/L subgroups than the CRP <5 mg/L subgroup (Figure 1B). Across other efficacy measures, improvements were observed at Week 48 compared with baseline in all CZP-treated CRP subgroups (Table 1).

Conclusion: Clinically relevant responses were observed in MRI+ nr-axSpA patients treated with CZP, across CRP subgroups and measured outcomes. The responses in each subgroup were consistent with those previously reported in total nr-axSpA patient group.1 ASDAS-MI response rates were lower in the CRP <5 mg/L subgroup, however, CRP is a key factor in ASDAS derivation. It is unlikely that ASDAS-MI could be achieved in patients in the CRP <5 mg/L subgroup since most of them had CRP levels < LLoQ.

References: 1. Landewé R et al. Rheumatol Ther 2020;7:581–99. 2. Landewé R et al. Ann Rheum Dis 2020;79:920–28. 3. Robinson P et al. Int J Rheum Dis 2020;23:67–8. 4. Rudwaleit M et al. Ann Rheum Dis 2009;68:1520–7. 5. Machado P et al. Arthritis Rheumatol 2015;67:408–13.

Figure 1

Table 1


Disclosures: P. Robinson, Abbvie, 1, Novartis, 1, 5, 6, Atom Biosciences, 1, Janssen, 5, 6, Eli Lilly, 1, 2, 6, Gilead, 6, UCB Pharma, 1, 5, 6, Pfizer, 1, 5, 6, Roche, 6; S. Hall, AbbVie, 2, 6, Eli Lilly, 2, 6, Janssen, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, UCB, 2, 6, Bristol-Myers Squibb, 2, 5, Merck, 2, 5, 6; B. Hoepken, UCB Pharma, 3, 11; L. Bauer, UCB Pharma, 3, 11; E. Demas, UCB Pharma, 3; M. Kim, UCB Pharma, 3, 11; A. Deodhar, Amgen, 2, Celgene, 2, Boehringer Ingelheim, 2, 12, Paid Instructor, AbbVie, 2, 5, Eli Lilly, 2, 5, Glaxo Smith & Kline, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, 6, 12, Paid Instructor, UCB, 2, 5, Janssen, 2, 6, Bristol-Myers Squibb, 2.

To cite this abstract in AMA style:

Robinson P, Hall S, Hoepken B, Bauer L, Demas E, Kim M, Deodhar A. Response to Certolizumab Pegol in Patients with Non-Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Cut-Offs: Post-Hoc Analysis from a Phase 3 Multicenter Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/response-to-certolizumab-pegol-in-patients-with-non-radiographic-axial-spondyloarthritis-by-baseline-c-reactive-protein-cut-offs-post-hoc-analysis-from-a-phase-3-multicenter-study/. Accessed January 28, 2023.
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