Background Axial spondyloarthritis (axSpA), including patients (pts) with ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA), is associated with a significant burden of disease and typically affects pts of working age.1 AS has a substantial impact on pt absenteeism, as well as impeding performance at work and home;2 limited data are available for nr-axSpA. AxSpA can also present a significant burden to caregivers.3 Effective long-term treatments should minimize work disability, allowing pts to maintain employment and independence in household work.
Objectives To report the long-term effect of certolizumab pegol (CZP) treatment on workplace and household productivity and social participation in axSpA pts over 4 years (204 weeks [wks]).
Methods The RAPID-axSpA trial (NCT01087762) was double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk204. Pts had active disease and fulfilled ASAS criteria. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W) continued on assigned dose in the OL period. The validated arthritis-specific Work Productivity Survey (WPS)4 assessed the impact of disease on workplace and household productivity and social participation. Data are reported for pts originally randomized to CZP (randomized set) using LOCF imputation and as observed values for pts completing each study visit.
Results 325 pts were randomized, of whom 218 received CZP from Wk0. Of the 218 pts, 203 (93%) completed Wk24 and 142 (65%) Wk204. 157/218 (72%) pts were employed outside the home at baseline (BL). Pts reported a high BL burden of arthritis, with a mean of 7.0 days of paid work (employed pts, n=157), 12.8 days of household work, and 4.0 days of social activities (all pts, n=218) affected in the previous month.
Initial improvements in workplace and household productivity to Wk24 of CZP treatment were further sustained to Wk204 in axSpA pts, as well as in both the AS and nr-axSpA subpopulations (Table). Improvements were seen in social participation, with the number of days of family/social/leisure activities missed in the previous month reduced from 4.0 (BL) to 1.5 at Wk24 and 0.7 at Wk204 (LOCF, n=218). Caregiver burden also improved over time with 40.8% of pts at BL needing regular assistance in usual activities from a relative or friend, decreasing to 26.6% at Wk24 and 12.4% at Wk204 (LOCF, n=218, data from socio-professional module collected at each study visit).
Conclusions Initial improvements seen to Wk24 with CZP treatment in workplace and household productivity, increased social participation and reduced caregiver burden further continued over long-term (4-year) treatment of axSpA, AS and nr-axSpA pts, suggesting sustained benefits to pts' lives and society.
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Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance.
Disclosure of Interest D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma, Employee of: Director of Imaging Rheumatology B.V., J. Braun Grant/research support from: Abbott, BMS, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma, Consultant for: Abbott, BMS, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma, M. Rudwaleit Consultant for: Abbott, BMS, Janssen, MSD, Pfizer, Roche and UCB Pharma, R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, Consultant for: Abbott, Ablynx, Amgen, Astra-Zeneca, BMS, Centocor, Glaxo-Smith-Kline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, Speakers bureau: Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, O. Purcaru Employee of: UCB Pharma, A. Kavanaugh Grant/research support from: Abbott, Amgen, BMS, Pfizer, Roche, Janssen, UCB Pharma.