Earlier Treatment of Non-Radiographic Axial Spondyloarthritis with Certolizumab Pegol Results in Improved Clinical and Patient-Reported Outcomes

Jonathan Kay¹, Lianne Gensler ², Atul Deodhar ³, Walter P. Maksymowych ⁴, Nigil Haroon ⁵, Simone Auteri ⁶, Natasha de Peyrecave ⁷, Thomas Kumke ⁸, Bengt Hoepken ⁹, Lars Bauer ⁹ and Martin Rudwaleit ¹⁰, ¹UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, ²University San Francisco California, San Francisco, CA, ³Oregon Health & Science University, Portland, OR, ⁴University of Alberta/CARE ARTHRITIS, Edmonton, AB, Canada, ⁵Toronto Western Hospital, Krembil Research Institute, University of Toronto, Toronto, ON, Canada, ⁶UCB Pharma, Brussels, Belgium, ⁷UCB Pharma, Slough, United Kingdom, ⁸UCB Pharma, Monheim, Germany, ⁹UCB Pharma, Monheim am Rhein, Germany, ¹⁰Klinikum Bielefeld, Charité Berlin, Gent University, Bielefeld, Germany

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: anti-TNF therapy, axial spondyloarthritis, certolizumab pegol and non-radiographic

Session Information

Date: Sunday, November 10, 2019

Title: 3S111: Spondyloarthritis Including Psoriatic Arthritis – Clinical II: Axial Spondyloarthritis Treatment (933–938)

Session Type: ACR Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Patients (pts) with axial spondyloarthritis (axSpA) often experience delayed diagnosis, which can lead to treatment delay. However, there are indications that earlier treatment with anti-TNFs can lead to a greater clinical response. Certolizumab pegol (CZP) has been shown to improve the signs and symptoms of non-radiographic (nr)-axSpA.¹ However, it is not known if earlier CZP treatment has a greater impact on efficacy in nr-axSpA. Here we report clinical and pt-reported outcomes in pts with active nr‑axSpA treated with CZP or placebo (PBO) over 52 weeks (wks) stratified by their symptom duration.

Methods: C-axSpAnd (NCT02552212) is a 3-year, phase 3, multicenter study including a 52‑wk double-blind, PBO-controlled period (completed).1 Pts had previous inadequate response to ≥ 2 NSAIDs and were randomized 1:1 to PBO or CZP (400 mg at Wks 0/2/4, then 200 mg every 2 wks). This post-hoc analysis reports outcomes at Wk 12 and Wk 52 in pts stratified by their baseline symptom duration (< 5 and ≥ 5 years; key clinical outcomes also reported for < 3 and ≥ 3 years). Outcomes included: Ankylosing Spondylitis Disease Activity Score – Major Improvement (ASDAS-MI), Assessment in SpondyloArthritis international Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), nocturnal spinal pain, fatigue (BASDAI Q1), morning stiffness (average of BASDAI Q5 and Q6), and the 36-Item Short Form Survey (SF-36) physical and mental component summary (PCS/MCS). Subjects with missing values or values observed after discontinuing double-blind study treatment were considered as non-responders for binary measures or, for quantitative measures, had the last observation from double‑blind treatment carried forward

Results: Of 317 recruited pts, 159 were randomized to CZP, and 158 to PBO. The median (range) baseline (BL) symptom duration was 4.9 (1.0–41.9) years for CZP-treated pts and 5.2 (1.1–38.2) years for PBO pts. 50.3% (80/159) CZP pts and 48.7% (77/158) PBO pts had a symptom duration < 5 years. At Wks 12 and 52, ASDAS-MI and ASAS40 responder rates, and improvements in BASDAI, nocturnal spinal pain, fatigue, morning stiffness and SF-36 PCS were substantially better among CZP-treated pts with shorter symptom duration (< 5 years at BL) vs longer symptom duration (Table). Amongst PBO pts, responses were low and there was no consistent trend in outcomes by symptom duration (Table). Similarly, using a cut-off of 3 years, responder rates for ASDAS-MI and ASAS40 were greater in CZP-treated pts with shorter symptom duration: at Wk 52, 56.4% (31/55) and 42.3% (44/104) of pts with < 3 and ≥ 3 years symptom duration achieved ASDAS-MI, respectively, while 65.5% (36/55) and 51.9% (54/104) achieved ASAS40.

Conclusion: In this post-hoc analysis, CZP-treated nr-axSpA pts with shorter symptom duration (< 5 vs ≥ 5 years) showed greater improvements across signs and symptoms of disease and in quality of life. To our knowledge, this is the first report indicating that early CZP treatment for nr-axSpA may be beneficial to pts.

References:

1. Deodhar A. Arthritis Rheumatol 2019; doi: 10.1002/art.40866.

Disclosure: J. Kay, AbbVie, 5, Abbvie, 5, Abbvie, Boehringer Ingelheim, Celltrion, Horizon Therapeutics, Merck, MorphoSys AG, Norvartis AG, Pfizer, Samsung Bioepis, Sandoz Inc., UCB Pharma, 5, AbbVie, Inc., 5, Boehringer Ingelheim GmbH, 5, Boehringer-Ingelheim, 5, Boehringer-Ingelheim GmbH, 5, Celltrion Healthcare, 5, Celltrion Healthcare Co. Ltd, 5, Celltrion Healthcare CO. Ltd, 5, Celltrion Healthcare Co. Ltd., 5, Gilead, 2, Gilead Sciences, 5, Gilead Sciences, Inc, 2, Gilead Sciences, Inc., 2, Gilead Sciences, Inc., Novartis AG, Pfizer, UCB Pharma, 2, Horizon Therapeutics, 5, Horizon Therapeutics PLC, 5, Merck Sharp & Dohme, 5, Merck Sharp & Dohme Corp, 5, Merck Sharp & Dohme Corp., 5, MorphoSys AG, 5, Novartis AG, 2, 5, Novartis Pharmaceuticals, 5, Pfizer, 2, 5, Pfizer Inc, 2, 5, Pfizer Inc., 2, 5, Samsung Bioepis, 5, Samsung Bioepis Co., Ltd., 5, Sandoz, 5, Sandoz Inc, 5, UCB, 2, 5, UCB Pharma, 2, 5, UCB, Inc., 2, 5; L. Gensler, AbbVie, 2, 5, Abbvie, 2, 9, Amgen, 2, Amgen, AbbVie and Novartis, 2, Center for Disease Control, 8, Division of Vaccine Injury Compensation, 8, Eli Lilly, 5, 9, Eli Lilly and Company, 9, Galapagos, 5, 9, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB, 5, Janssen, 5, 9, Novartis, 2, 5, 9, Pfizer, 2, 9, Spondylitis Association of America, 6, Spondyloarthritis Research and Treatment Network (SPARTAN), 6, UCB, 2, 5, 9, UCB Pharma, 2, 9; A. Deodhar, AbbVie, 2, 5, 9, Abbvie, 5, 8, Abbvie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, and UCB Pharma, 5, 8, AbbVie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GSK, Galapagos, Janssen, Novartis, Pfizer and UCB, 5, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer, UCB, 5, Amgen, 5, 8, 9, BMS, 2, 5, 8, BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, UCB, 2, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, UCB Pharma, 2, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 5, 8, Bristol Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, 8, Eli Lilly, 2, 5, 8, 9, Eli Lilly and Company, 2, 5, Eli Lilly,, 5, Eli Lilly, GSK, Novartis, Pfizer and UCB, 2, Galagagos, 5, Galapagos, 5, 8, 9, Glaxo Smith & Klein, 2, Glaxo Smith & Kline, 2, 5, 8, Glaxo Smith Klein, 5, Glaxo SmithKlein, 2, 5, GlaxoSmithKlein, 2, 5, GlaxoSmithKline, 2, 5, 8, GSK, 2, 5, Janssen, 2, 5, 8, 9, Janssen Pharmaceutica, 2, 5, Janssen Research & Development, LLC, 2, Lilly, 2, 5, Novartis, 2, 5, 8, 9, Pfizer, 2, 5, 8, 9, UCB, 2, 5, 8, 9; W. Maksymowych, Abbvie, 2, 5, 8, AbbVie, 2, 5, 8, AbbVie Inc., 2, 5, 8, Abbvie, Amgen, Eli Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi, and UCB Pharma ], 2, 5, 8, Amgen, 2, 5, 8, Boehringer, 5, 8, Boehringer-Ingelheim, 5, 8, Canadian Research and Education Arthritis, 6, CARE ARTHRITIS, 3, 6, 9, Celgene, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, 8, Janssen, 2, 5, 8, Lilly, 2, 5, 8, Merck, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Sanofi, 2, 5, 8, Synarc, 2, 5, 8, UCB, 2, 5, 8, UCB Pharma, 2, 5, 8; N. Haroon, Abbive, Amgen, Janssen, Eli Lilly, Novartis AG, UCB Pharma, 5, 8, Abbvie, 5, 8, Amgen, 5, 8, Eli Lilly, 5, 8, Janssen, 5, 8, Merck, 5, 8, Novartis, 5, 8, UCB Pharma, 5, 8; S. Auteri, UCB Pharma, 3; N. de Peyrecave, UCB Pharma, 3; T. Kumke, UCB Pharma, 3; B. Hoepken, UCB Pharma, 3; L. Bauer, UCB Pharma, 3; M. Rudwaleit, Abbott, 5, AbbVie, 5, 8, BMS, 5, 8, Bristol Myers-Squibb, 5, 8, Celgene, 5, 8, Chugai, 5, 8, Eli Lilly, 5, 8, Eli Lily, 5, 8, Janssen, 5, 8, MSD, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Roche, 5, 8, UCB Pharma, 5, 8.

To cite this abstract in AMA style:

Kay J, Gensler L, Deodhar A, Maksymowych W, Haroon N, Auteri S, de Peyrecave N, Kumke T, Hoepken B, Bauer L, Rudwaleit M. Earlier Treatment of Non-Radiographic Axial Spondyloarthritis with Certolizumab Pegol Results in Improved Clinical and Patient-Reported Outcomes [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/earlier-treatment-of-non-radiographic-axial-spondyloarthritis-with-certolizumab-pegol-results-in-improved-clinical-and-patient-reported-outcomes/. Accessed .

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