Background/Purpose:

Axial spondyloarthritis (axSpA) includes both ankylosing spondylitis (AS) and non-radiographic axial SpA (nr-axSpA). AS significantly affects patients’ (pts) work productivity.¹ The impact of the entire spectrum of axSpA on work productivity is still poorly researched. RAPID-axSpA (NCT01087762) is the first report of the effect of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, on paid and household work productivity, and daily activities, in pts with axSpA.

Methods:

Recruited pts had adult-onset active axSpA as defined by the ASAS criteria,¹ BASDAI ≥4, spinal pain ≥4 on a 10 point scale, CRP > upper limit of normal or sacroillitis on MRI. Pts must have failed ≥1 NSAID. Up to 40% of pts could have experienced secondary failure to 1 previous anti-TNF. The pt population reflected the broad axSpA population, including AS pts also meeting the modified New York criteria and nr-axSpA pts who met the ASAS MRI or clinical criteria. Pts were randomized 1:1:1 to PBO, or CZP 400mg at Week (Wk) 0, 2 and 4 (loading dose, LD) followed by either CZP 200mg every 2 wks (Q2W) or CZP 400mg every 4 wks (Q4W). Pts receiving PBO who failed to achieve an ASAS20 response at both Wks 14 and 16 were rescued and randomized at Wk16 to receive CZP 200mg Q2W or CZP 400mg Q4W following LD.  The arthritis-specific Work Productivity Survey (WPS) assessed the impact of axSpA on workplace and household productivity. WPS was administered every 4 wks. WPS responses (last observation carried forward imputation) were compared between treatment arms using a non-parametric bootstrap-t method.

Results:

325 pts were randomized. 63.2%, 69.4%, and 74.8% of pts in the PBO, CZP 200mg Q2W, and CZP 400mg Q4W treatment groups were employed at study BL; 11%-13% of pts were unable to work due to axSpA; 4%-9% were students; 3%-8% were retired. Treatment groups were comparable at BL in terms of workplace and household productivity. At BL the burden of axSpA on absenteeism, presenteeism, household productivity and social activities was high (Table). Compared to PBO, pts employed in both CZP groups reported reduced absenteeism, presenteeism, and axSpA interference with work from Wk4 through to Wk24 (Table). CZP groups also reported greater reductions vs PBO in days lost of household work and of family/social/leisure activities per month, in days with reduced household productivity and in axSpA interference with household duties as early as Wk4 through to Wk 24 (Table).

Conclusion:  

CZP improved workplace productivity in pts with axSpA by reducing absenteeism, presenteeism and axSpA interference with work. CPZ also improved household productivity and increased participation in social and daily activities.

References:

1. Boonen A, Ann Rheum Dis 2010;69:6 1123-1128
2. Rudwaleit M, Ann Rheum Dis 2009;68:6 770-776.

Table. Work and household productivity in RAPID-axSpA study (FAS population, LOCF data)