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Abstract Number: 1358

Certolizumab Pegol Efficacy in Patients with Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status

Atul Deodhar1, Lianne Gensler2, Stephen Hall3, Philip Robinson4, Bengt Hoepken5, Lars Bauer5, Thomas Kumke5 and Walter Maksymowych6, 1Oregon Health & Science University, Portland, OR, 2University of California San Francisco, San Francisco, CA, 3Cabrini Medical Centre, Monash University and Emeritus Research, Malvern, Victoria, Australia, 4University of Queensland, Herston, Queensland, Australia, 5UCB Pharma, Monheim am Rhein, Germany, 6University of Alberta, Edmonton, AB, Canada

Meeting: ACR Convergence 2020

Keywords: Anti-TNF Drugs, Biologicals, C-reactive protein (CRP), Magnetic resonance imaging (MRI), spondyloarthritis

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Session Information

Date: Sunday, November 8, 2020

Session Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster III

Session Type: Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: This post-hoc analysis from the phase 3 C-axSpAnd study aimed to evaluate whether the response to certolizumab pegol (CZP) in non-radiographic axial spondyloarthritis (nr-axSpA) is impacted by patients’ baseline MRI and C-reactive protein (CRP) status.

Methods: C-axSpAnd (NCT02552212) is a 3-year, phase 3, multicenter study including a completed 52‑week double-blind, placebo-controlled period.1 Patients were adults with a diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS), but not modified New York, classification criteria, active disease (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] >4, spinal pain >4), objective signs of inflammation (C‑reactive protein [CRP] >10 mg/mL [CRP+] and/or evidence of sacroiliitis on MRI [MRI+]), who had failed ≥2 non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomized 1:1 to placebo or CZP (400 mg at Weeks 0, 2 and 4, then 200 mg every 2 weeks), which they received in addition to non-biologic background medication for 52 weeks. Adjustments to background medication or switching to open-label CZP (or other biologics) at any point was permitted. We report Ankylosing Spondylitis Disease Activity Score – major improvement (ASDAS-MI) and ASAS 40% response (ASAS40) for CZP-randomized patients according to prespecified subgroups based on MRI/CRP status (MRI+/CRP+, MRI−/CRP+, MRI+/CRP−). Comparisons between MRI/CRP subgroups are descriptive only; Week 12 (ASAS40) and Week 52 (ASDAS-MI) comparisons between CZP and placebo were pre-specified. Missing values, or values collected after switching to open-label treatment, were imputed using non-responder imputation.

Results: At baseline, a total of 317 patients were randomized, 159 to CZP (45 MRI+/CRP+, 40 MRI−/CRP+ and 74 MRI+/CRP−) and 158 to placebo (42 MRI+/CRP+, 40 MRI−/CRP+ and 76 MRI+/CRP−). At Week 52, ASDAS-MI was achieved in 47.2% and 7.0% of CZP and placebo-treated patients, respectively, and ASAS40 in 56.6% and 15.8%. When stratified by MRI/CRP status, response rates in all three subgroups for CZP-treated patients were also higher compared to placebo for both ASDAS-MI and ASAS40 at Week 12 and Week 52 (Figure 1). For ASDAS-MI, there was a greater difference in response rates between subgroups compared with ASAS40, with numerically higher response rates in the MRI+/CRP+ and MRI−/CRP+ subgroups vs the MRI+/CRP− subgroup (Figure 1a). Since the ASDAS value is largely dependent on the CRP value, this is to be expected. For ASAS40, the main secondary outcome, a numerically higher response rate was also observed for the MRI+/CRP+ group, while response rates were comparable for the other groups (Figure 1b).

Conclusion: Clinically relevant responses were observed in nr-axSpA patients with either MRI and/or CRP positivity, with the highest response seen in the MRI+/CRP+ subgroup.

Reference: 1. Deodhar A. Arthritis Rheumatol 2019;71:1101–11.


Disclosure: A. Deodhar, AbbVie, 2, 5, Eli Lilly, 2, 5, GlaxoSmithKline, 2, 5, Novartis, 2, 5, Janssen, 5, Pfizer, 2, 5, Boehringer Ingelheim, 5, UCB Pharma, 2, 5, Amgen Inc., 5, Celgene, 5, Galapagos, 5, Bristol-Myers Squibb, 2; L. Gensler, AbbVie, 5, GlaxoSmithKline, 5, Eli Lilly, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB Pharma, 2, 5; S. Hall, AbbVie, 1, 2, Bristol-Myers Squibb, 1, 2, Lilly, 1, 2, Janssen, 1, 2, Pfizer, 1, 2, UCB Pharma, 1, 2, Novartis, 1, 2; P. Robinson, Abbvie, 5, Eli Lilly, 5, Janssen, 5, Pfizer, 5, UCB, 5, Novartis, 5, Roche, 9, BMS, 9; B. Hoepken, UCB Pharma, 1, 3; L. Bauer, UCB Pharma, 1, 3; T. Kumke, UCB Pharma, 1, 3; W. Maksymowych, AbbVie, 2, 5, Janssen, 5, Lilly, 5, Pfizer, 2, 5, Novartis, 2, 5, Gilead, 5, UCB Pharma, 5, Boehringer Ingelheim, 5, Galapagos, 5.

To cite this abstract in AMA style:

Deodhar A, Gensler L, Hall S, Robinson P, Hoepken B, Bauer L, Kumke T, Maksymowych W. Certolizumab Pegol Efficacy in Patients with Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/certolizumab-pegol-efficacy-in-patients-with-non-radiographic-axial-spondyloarthritis-stratified-by-baseline-mri-and-c-reactive-protein-status/. Accessed April 11, 2021.
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