Certolizumab Pegol Improves Work and Household Productivity and Social Participation over 1 Year of Treatment in Patients with Non-Radiographic Axial Spondyloarthritis

Atul Deodhar¹, Lianne Gensler ², Jonathan Kay ³, Walter P. Maksymowych ⁴, Nigil Haroon ⁵, Robert B.M. Landewé ⁶, Martin Rudwaleit ⁷, Stephen Hall ⁸, Lars Bauer ⁹, Bengt Hoepken ⁹, Natasha de Peyrecave ¹⁰, Thomas Kumke ¹¹ and Désirée van der Heijde ¹², ¹Oregon Health & Science University, Portland, OR, ²University San Francisco California, San Francisco, CA, ³UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, ⁴University of Alberta/CARE ARTHRITIS, Edmonton, AB, Canada, ⁵Toronto Western Hospital, Krembil Research Institute, University of Toronto, Toronto, ON, Canada, ⁶Amsterdam University Medical Center, Amsterdam, Netherlands, ⁷Klinikum Bielefeld, Charité Berlin, Gent University, Bielefeld, Germany, ⁸Monash University and Emeritus Research, Melbourne, Australia, ⁹UCB Pharma, Monheim am Rhein, Germany, ¹⁰UCB Pharma, Slough, United Kingdom, ¹¹UCB Pharma, Monheim, Germany, ¹²Leiden University Medical Center, Leiden, Netherlands

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: axial spondyloarthritis, certolizumab pegol, non-radiographic, work and Social Participation

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

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

Background/Purpose: Patients (pts) with non-radiographic axial spondyloarthritis (nr-axSpA) report substantial impairment of productivity and daily activities due to the burden of their disease, similar to pts with ankylosing spondylitis.^1,2 Certolizumab pegol (CZP) treatment has been shown to significantly improve work and household productivity and social participation compared to placebo (PBO) in active nr-axSpA pts up to 24 weeks (wks).¹Improvements were maintained over 4 years of CZP treatment in RAPID-axSpA.³ The C-axSpAnd study demonstrated the impact of CZP in combination with non-biologic background medication (NBBM) on signs and symptoms of nr-axSpA compared to PBO + NBBM.⁴ Here, we report work and household productivity and social participation from C-axSpAnd.

Methods: C-axSpAnd (NCT02552212) is a 3-year, phase 3, multicenter study including a 52 wk double-blind, PBO-controlled period (completed). Pts had active nr-axSpA, objective signs of inflammation (elevated CRP and/or positive MRI of the sacroiliac joint), and previous inadequate response to ≥2 NSAIDs and were randomized 1:1 to CZP (400 mg at Wks 0, 2, and 4, then 200 mg every 2 wks) + NBBM or PBO + NBBM. The validated arthritis-specific Work Productivity Survey (WPS) assessed the impact of nr-axSpA on work and household productivity and social participation.⁵ Missing data were imputed using last observation carried forward (LOCF) post hoc in the Full Analysis Set (FAS, all randomized pts who received ≥1 dose of study medication).

Results: 317 pts were randomized (CZP + NBBM: 159; PBO + NBBM: 158). Mean age at baseline (BL) was 37.3 years and 51.4% of pts were female. At BL, the majority of pts (CZP + NBBM: 124 [77.8%]; PBO + NBBM: 123 [78.0%] pts) were employed and reported a mean 3.7 (CZP + NBBM) and 3.5 (PBO + NBBM) work days missed per month due to their disease (Table). By Wk 12, work absenteeism substantially improved in the CZP + NBBM group compared with the PBO + NBBM group (0.9 vs 2.1 days missed per month, LOCF), with further improvements at Wk 52 (0.3 vs 2.0 days missed per month, LOCF). Between Wk 12 and Wk 52, a majority of PBO pts (104 [65.8%]) switched to open-label CZP, impacting imputed outcomes at Wk 52. Despite this, similar patterns of improvement following CZP + NBBM treatment were seen for absenteeism, work days with impaired productivity, household days with missed/reduced productivity and social participation between imputed and observed case data (Table). Improvements were similar between male and female pts (data not shown).

Conclusion: CZP treatment resulted in improvements in work and household productivity and social participation for nr-axSpA pts as early as Wk 12 compared to background medication only, with benefits maintained to Wk 52.

References

1. van der Heijde D. RMD Open 2018;4:e000659; 2. Keat A. Rheumatol Int. 2017;37(3):327-36; 3. van der Heijde D. ARD 2016;75:809; 4. Deodhar A. Arthritis Rheum 2019;doi:10.1002/art.40866; 5. Osterhaus JT. Arthritis Res Ther 2014;16:R164

Disclosure: 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; 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; 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; 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; R. Landewé, Abbott, 2, 5, 8, Abbott, Amgen, Bristol-Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB, Wyeth, 8, Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, Wyeth, 2, AbbVie, 5, Abbvie, 5, 8, AbbVie, Ablynx, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering- Plough, UCB, Wyeth, 5, Ablynx, 5, Amgen, 2, 5, 8, AstraZeneca, 5, BMS, 5, 8, Bristol Myers Squibb, 5, 8, Bristol-Myers Squibb, 5, Celgene, 5, 8, Centocor, 2, 5, 8, Director of Rheumatology Consultancy BV, which is a registered company under Dutch law, 6, Eli Lilly, 5, 8, Eli Lilly and Company, 5, Eli-Lilly, 5, 8, Galapagos, 5, 8, Gilead, 5, 8, GlaxoSmithKline, 5, Glaxo-Smith-Kline, 5, 8, Janssen, 5, 8, Merck, 5, 8, MSD, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Rheumatology bv, 4, Rheumatology Consultancy BV, 9, Roche, 2, 5, 8, Schering-Plough, 2, 5, 8, UCB, 5, 8, UCB Pharma, 2, 5, 8, Wyeth, 2, 5, 8; 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; S. Hall, AbbVie, 2, 5, BMS, 2, 5, Eli Lilly, 2, 5, Janssen, 2, 5, Lilly, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5, UCB Pharma, 2, 5; L. Bauer, UCB Pharma, 3; B. Hoepken, UCB Pharma, 3; N. de Peyrecave, UCB Pharma, 3; T. Kumke, UCB Pharma, 3; D. van der Heijde, AbbVie, 5, AbbVie, Amgen, Astellas, AstraZeneca, BMS, 5, Amgen, 5, Astellas, 5, 9, Astellas Pharma, 5, AstraZeneca, 5, BMS, 5, Boehringer Ingelheim, 5, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB, 5, Boehringer-Ingelheim, 5, Bristol-Myers Squibb, 5, Celgene, 5, Daiichi, 5, 9, Daiichi Sankyo, 5, Director of Imaging Rheumatology, 6, Director of Imaging Rheumatology bv, 9, Eli Lilly, 5, Eli Lilly and Company, 5, Eli-Lilly, 5, Galapagos, 5, Gilead, 5, Gilead Sciences, Inc., 5, GlaxoSmithKline, 5, Glaxo-Smith-Kline, 5, GSK, 5, 8, Imaging Rheumatology bv, 9, Imaging Rheumatology BV, 9, Imaging Rheumatology bv., 9, Janssen, 5, 8, Janssen Pharmaceutica, 5, Merck, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Pfizer Inc, 5, Regeneron, 5, 8, Rheumatology bv, 4, 9, Roche, 5, 8, Sanofi, 5, 8, Takeda, 5, 8, Takeda Pharmaceutical Company, 5, UCB, 5, 8, UCB Pharma, 5.

To cite this abstract in AMA style:

Deodhar A, Gensler L, Kay J, Maksymowych W, Haroon N, Landewé R, Rudwaleit M, Hall S, Bauer L, Hoepken B, de Peyrecave N, Kumke T, van der Heijde D. Certolizumab Pegol Improves Work and Household Productivity and Social Participation over 1 Year of Treatment in Patients with Non-Radiographic Axial Spondyloarthritis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/certolizumab-pegol-improves-work-and-household-productivity-and-social-participation-over-1-year-of-treatment-in-patients-with-non-radiographic-axial-spondyloarthritis/. Accessed .

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