Pain, disease activity may hamper work productivity for AS patients

New analysis covers productivity results of 2 clinical trials testing Xeljanz

Margarida Maia PhD avatar

by Margarida Maia PhD |

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A person puts a hand to the forehead in frustration while looking at papers on a table, as a black cloud hovers in the background.

People with ankylosing spondylitis (AS) who report more severe pain and disease activity, and poorer quality of life, continue to work despite their AS — yet their productivity is far less than that of patients whose outcomes are not as severe.

That’s according to a new analysis of data from two clinical trials involving nearly 500 adults with AS treated with the approved therapy Xeljanz or a placebo. Xeljanz is designed for AS patients who’ve had an inadequate response or are intolerant to one or more therapies that suppress the immune system.

The analysis stemming from the two trials — one a Phase 2 study (NCT01786668) and the other a Phase 3 (NCT03502616) — was designed to “examine the relationships of work productivity and activity impairment with key patient-reported outcomes (PROs) assessing pain, disease activity, and health-related quality of life (HRQoL).”

The findings, according to researchers, “suggest that interventions that control disease activity and pain are likely to reduce daily activity impairment and productivity loss in patients with AS.”

The analysis is detailed in “Relationships of Work Productivity and Activity Impairment with Patient-Reported Outcomes in Ankylosing Spondylitis: Results from Two Trials,” published in Arthritis Care & Research. It was funded by Pfizer, which markets Xeljanz.

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Investigating relationship between disease outcomes and productivity

AS occurs when the joints of the spine (backbone) and other parts of the body become inflamed. Inflammation in the joints can cause a range of symptoms, including pain, stiffness, and fatigue.

Because the disease often affects young people of working age, the challenges it brings can result in missing work, worse performance at work, job loss, and sometimes, retiring early.

Xeljanz is an oral medication approved to treat adults with active AS who have failed to respond to, or could not tolerate, one or more anti-inflammatory TNF inhibitors. Xeljanz helps reduce inflammation, thereby easing symptoms of AS.

A 2022 analysis of Phase 3 clinical trial data revealed that taking 5 mg of Xeljanz twice a day eased pain and fatigue, and improved quality of life and work productivity, as compared with a placebo, for 16 weeks, or about four months. The benefits were found to last up to almost one year.

However, it is not clear how patient-reported outcomes relate to work productivity. To know more, an international team of researchers, including scientists at Pfizer, drew on data from the two Xeljanz clinical trials. Data from 330 to 475 patients were available.

Total and nighttime back pain was scored on a scale from 0 to 10, with higher scores indicating more severe pain. The Patient Global Assessment of Disease Activity (PtGA) also uses a scale from 0 to 10, with higher scores indicating more active disease.

The EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire measures health-related quality of life across five dimensions — mobility, self-care, usual activities, pain/discomfort, and anxiety/depression — with three response levels. Scores range from 0, or worst, to 1, or best. Also used was the EuroQol 5-Dimension Visual Analog Scale (EQ-5D-VAS), which has a scale from 0 to 100, with higher scores reflecting better health status.

The Work Productivity and Activity Impairment Questionnaire in Spondyloarthritis scores absenteeism, defined as missed work time, and presenteeism, or work hours with decreased productivity, as well as productivity loss and activity impairment. On this measure, higher scores indicate less productivity.

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Issue may be not absenteeism, but less productivity at work

The results showed that the highest scores for back pain and disease activity, and the lowest scores for EQ-5D-3L and EQ-5D-VAS indicating poorer quality of life, were linked to up to 93% presenteeism, up to 97.5% productivity loss, and up to 99.5% activity impairment.

Conversely, the lowest scores for back pain and disease activity, and the highest scores for EQ-5D-3L and EQ-5D-VAS, were tied to up to 18% presenteeism, up to 19.9% productivity loss, and up to 22.7% activity impairment.

“Evidence of linear relationships between work productivity and activity impairment with patient-reported pain, disease activity, and [health-related quality of life] was observed,” the researchers wrote.

However, “improvement in [patient-reported outcomes] was associated with improvement of activity impairment, presenteeism, and productivity loss,” meaning that interventions that control pain and disease activity are likely to increase productivity at work.

For example, a decrease in total back pain by one point — marking an improvement for patients — was linked to a 6.1% improvement in presenteeism, 6.4% improvement in productivity loss, and 7.1% improvement in activity impairment.

Similar observations were made for improvements in nighttime back pain and health-related quality of life.

[Low absenteeism] could indicate that productivity loss due to AS observed in this study was driven by presenteeism rather than absenteeism, with people going to work but not achieving their full potential.

In general, absenteeism was low and not influenced as much by patient-reported outcomes.

“This could indicate that productivity loss due to AS observed in this study was driven by presenteeism rather than absenteeism, with people going to work but not achieving their full potential,” the researchers wrote.

While the findings come from patients who took part in clinical trials and “may not be generalizable to the wider population of patients with AS,” real-world data could possibly support these findings, the researchers noted.

The team noted that work is important to people with AS, referencing a recent registry study that showed that “employment was significantly associated with less disease activity and pain … better physical function, and better self-rated health.”

The study was limited by its small size and retrospective nature, they also noted.