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Spondyloarthritis
Original article
Improvements in workplace and household productivity with certolizumab pegol treatment in axial spondyloarthritis: results to week 96 of a phase III study
  1. Désirée van der Heijde1,
  2. Jürgen Braun2,
  3. Martin Rudwaleit3,
  4. Oana Purcaru4 and
  5. Arthur F Kavanaugh5
  1. 1 Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  2. 2 Rheumazentrum Ruhrgebiet, Herne, Germany
  3. 3 Department of Internal Medicine and Rheumatology, Klinikum Bielefeld Rosenhöhe, Bielefeld, Germany
  4. 4 UCB Pharma, Brussels, Belgium
  5. 5 Division of Rheumatology, Allergy and Immunology, University of California, San Diego, San Diego, California, USA
  1. Correspondence to Professor Désirée van der Heijde; mail{at}dvanderheijde.nl

Abstract

Objectives To evaluate the effect of certolizumab pegol (CZP) on work and household productivity, and on participation in family, social and leisure activities in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic (nr-) axSpA.

Methods RAPID-axSpA (NCT01087762) was a phase III, double-blind, placebo-controlled trial to week (Wk) 24, dose-blind to Wk48 and open-label to Wk204. A total of 325 patients were randomised 1:1:1 to placebo, CZP 200 mg Q2W or CZP 400 mg Q4W. The validated arthritis-specific Work Productivity Survey assessed the impact of axSpA on work and household productivity and participation in social activities during the preceding month. Data are shown to Wk96, with responses compared between treatment arms (placebo vs CZP 200 mg and 400 mg dose groups combined) and subpopulations using a non-parametric bootstrap-t method.

Results At baseline, 63.2% of placebo and 72.0% of CZP patients were employed. By Wk24, CZP patients reported on average 1.0 fewer days of absenteeism and 2.6 fewer days of presenteeism per month, compared with 0.4 and 0.9 fewer days for placebo. At home, by Wk24, CZP patients reported on average 3.0 household work days gained per month versus 1.3 for placebo. CZP patients reported fewer days with reduced household productivity or days lost for social participation. Similar improvements were observed in AS and nr-axSpA subpopulations and improvements with CZP were maintained to Wk96.

Conclusions Compared with placebo, treatment with CZP significantly improved work and household productivity and resulted in greater social participation for patients with axSpA, which could lead to considerable indirect cost gains.

Trial registration number NCT01087762.

  • ankylosing spondylitis
  • anti-TNF
  • autoimmune diseases
  • TNF-alpha
  • treatment

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/rmdopen-2018-000659

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    Footnotes

    • Contributors All authors made a substantial contribution to the conception or design of the work, or the acquisition, analysis or interpretation of data for the work. All authors revised the work critically, provided final approval of the version for publication and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Funding This work was supported by UCB Pharma, who funded this study and manuscript. UCB Pharma reviewed only for scientific and legal accuracy.

    • Competing interests DvdH: consulting fees: AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB Pharma, Director of Imaging at Rheumatology BV. JB: research grants and/or consulting fees: Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma. MR: consulting fees: Abbott, BMS, Janssen, MSD, Pfizer, Roche, UCB Pharma. OP: employee of UCB Pharma. AFK: research grants: Abbott, Amgen, Bristol-Myers Squibb, Pfizer, Roche, Janssen, UCB Pharma.

    • Patient consent Obtained.

    • Ethics approval Body varied by participating site.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.