ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 687

Safety and Efficacy of Certolizumab Pegol over 204 Weeks in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis

Atul A. Deodhar1, Maxime Dougados2, Robert Landewé3, Joachim Sieper4, Walter Maksymowych5, Martin Rudwaleit6, Filip van Den Bosch7, Jürgen Braun8, Philip J Mease9, Alan Kivitz10, Jessica Walsh11, Owen Davies12, Bengt Hoepken13, Luke Peterson14 and Désirée van der Heijde15, 1Divison of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, 2Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, 3Academic Medical Center, Amsterdam and Zuyderland Medical Center, Heerlen, Netherlands, 4Rheumatology Department, Charité – University Medicine Berlin, Berlin, Germany, 5Department of Medicine, University of Alberta, Edmonton, AB, Canada, 6Klinikum Bielefeld and Charité – University Medicine Berlin, Berlin, Germany, 7University Hospital Ghent, Ghent, Belgium, 8Rheumazentrum Ruhrgebiet, Herne, Germany, 9Swedish Medical Center and University of Washington, Seattle, WA, 10Altoona Center for Clinical Research, Duncansville, PA, 11Division of Rheumatology, University of Utah School of Medicine, Salt Lake City, UT, 12UCB Pharma, Slough, United Kingdom, 13UCB Pharma, Monheim, Germany, 14UCB Pharma, Raleigh, NC, 15Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands

Meeting: ACR/ARHP Annual Meeting 2016

Date of first publication: September 28, 2016

Keywords: , , ,

Session Information

Date: Sunday, November 13, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster I: Axial and Peripheral Spondyloarthritis – Clinical Aspects, Imaging and Treatment

Session Type: ACR Poster Session A

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

Background/Purpose: RAPID-axSpA (NCT01087762) investigated the efficacy and safety of certolizumab pegol (CZP) in patients (pts) with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic (nr)-axSpA. Previously, CZP treatment has been shown to improve the signs and symptoms of axSpA over 96 weeks (wks).1

Methods: RAPID-axSpA was double-blind and placebo-controlled to Wk 24, dose-blind to Wk 48 and open-label (OL) to Wk 204. Pts fulfilled ASAS criteria and had active axSpA with positive sacroiliac joint MRI and/or raised CRP (>7.9 mg/L). Pts randomized to CZP (200 mg Q2W or 400 mg Q4W) continued their assigned dose in the OL period. Efficacy data are presented for pts originally randomized to CZP (combined doses) as observed case (OC) and with imputation: NRI for categorical measures; LOCF for continuous measures. The safety set included all pts treated with ≥1 dose of CZP.

Results: 218/325 pts were randomized to CZP from Wk 0, of whom 65% (n=142) completed to Wk 204 (AS: 67% [n=81]; nr-axSpA: 63% [n=61]). In the OL period, 9.2% of pts withdrew due to an adverse event and 1.4% due to lack of efficacy. The proportion of pts achieving ASAS20/40 and partial remission (PR) responses at Wk 24 was maintained to Wk 204 in pts remaining in the study (Figure/Table). All other clinical and patient-reported outcomes also showed maintenance of efficacy to Wk 204, with similar improvements in AS and nr-axSpA pts (Table) and in both CZP dose regimens (data not shown). Spinal mobility (BASMI-linear) and function (BASFI) also improved in both subpopulations, improvements that were maintained until Wk 204. Nr-axSpA pts had lower scores at Wk 204, but also lower levels of impairment at baseline (BL). 148 pts had BL enthesitis (MASES >0). Increasing proportions of this group who completed to Wk 204 achieved complete enthesitis clearance (MASES=0; OC): 39.6% at Wk 12, 52.5% at Wk 24, and 63.5% at Wk 204. Similarly, of 52 pts with BL heel enthesitis (tenderness at proximal insertion of ≥1 Achilles tendon; OC), 48.0% achieved clearance at Wk 12, 65.3% at Wk 24, and 74.3% at Wk 204. Pts in the safety set (N=315) had a total CZP exposure of 981 patient-years (PY), with a serious adverse event rate per 100 PY of 10.4. Event rate for serious infections was 2.3/100 PY, for malignancies 0.5/100 PY and for serious cardiovascular events 0.4/100 PY. No new safety signals were identified from Wk 96 to Wk 204, and no deaths were reported over 4 years.

Conclusion: The RAPID-axSpA trial is the first study to report on the efficacy of an anti-TNF across the broad axSpA population, including both AS and nr-axSpA pts. Long-term data from this study show that pts from both subgroups treated with CZP were able to maintain improvements in disease activity, measured both clinically and by patient-reported outcomes, with no new safety signals, over 4 years of treatment. References: 1. Sieper J. Arthritis Rheum 2015;67:668–77

Disclosure: A. A. Deodhar, AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB Pharma, 2,AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB Pharma, 9; M. Dougados, AbbVie, Eli Lilly, Merck, Novartis, Pfizer, UCB Pharma, 2,AbbVie, Eli Lilly, Merck, Novartis, Pfizer, UCB Pharma, 5; R. Landewé, Abbott, Ablynx, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, 5,Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, 2,Abbott, Amgen, Bristol-Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, 8; J. Sieper, Abbott, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 8,Abbott, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 5; W. Maksymowych, AbbVie, Amgen, BioClinica, Eli Lilly, Janssen, Merck, Pfizer, Sanofi-Aventis, UCB Pharma, 5,AbbVie, Amgen, BioClinica, Eli Lilly, Janssen, Merck, Pfizer, Sanofi-Aventis, UCB Pharma, 8,AbbVie, Amgen, BioClinica, Eli Lilly, Janssen, Merck, Pfizer, Sanofi-Aventis, UCB Pharma, 2; M. Rudwaleit, Abbott, Bristol-Myers Squibb, Janssen, MSD, Pfizer, Roche, UCB Pharma, 5; F. van Den Bosch, AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Merck, Novartis, UCB Pharma, 5,AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 8; J. Braun, Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 5,Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 2; P. J. Mease, Abbott, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Crescendo, Eli Lilly, Genentech, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 2,Abbott, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Covagen, Crescendo, Eli Lilly, Genentech, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 5,Abbott, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Crescendo, Eli Lilly, Genentech, Janssen, Pfizer, UCB Pharma, 8; A. Kivitz, AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 2,Celgene, Genentech, Pfizer, UCB Pharma, 5; J. Walsh, Abbott, Celgene, UCB Pharma, 5; O. Davies, UCB Pharma, 3,UCB Pharma, 1; B. Hoepken, UCB Pharma, 3; L. Peterson, UCB Pharma, 3; D. van der Heijde, AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi, Eli Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, 5,Imaging Rheumatology BV, 9.

To cite this abstract in AMA style:

Deodhar AA, Dougados M, Landewé R, Sieper J, Maksymowych W, Rudwaleit M, van Den Bosch F, Braun J, Mease PJ, Kivitz A, Walsh J, Davies O, Hoepken B, Peterson L, van der Heijde D. Safety and Efficacy of Certolizumab Pegol over 204 Weeks in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/safety-and-efficacy-of-certolizumab-pegol-over-204-weeks-in-patients-with-axial-spondyloarthritis-including-ankylosing-spondylitis-and-non-radiographic-axial-spondyloarthritis/. Accessed .

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