Pain a 'key driver' of patient assessment of RA disease activity
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Pain is a “key driver” of patients’ perceptions regarding disease activity in rheumatoid arthritis, with physical function and fatigue playing lesser roles, according to data published in Arthritis Research & Therapy.
“Interestingly, discordance between patient and physician assessment of RA has been reported in over a third of RA patients, with patients with discordance typically reporting a higher level of disease activity than their physicians,” Vibeke Strand, MD, MACR, FACP, of Stanford University, and colleagues wrote. “Such discrepancies have been shown to negatively impact therapeutic outcomes, with discordance contributing to worse [health-related] QoL, activity impairment, and reduced work productivity.”
“Pain appears to be the most important domain to patients, whereas Physician Global Assessment of Arthritis (MDGA) is driven by physician-assessed measures of swollen and tender joint counts (SJC and TJC, respectively) and levels of inflammation markers,” they added. “As patients tend to weight pain into [Patient Global Assessment of Disease Activity (PtGA)] to a greater extent than physicians weight joint counts into MDGA, it is unsurprising that pain has been shown to be a key driver of discordance, with associated higher fatigue and disability scores.”
To examine the extent to which PtGA is driven by patient-reported pain, physician function and fatigue in those with RA being treated with tofacitinib (Xeljanz, Pfizer) or a placebo, Strand and colleagues conducted a post hoc analysis of three phase 3 randomized controlled trials. The included studies were the 12-month ORAL Sync trial, the ORAL Standard trial and the 24-month ORAL Scan trial. According to the researchers, these trials enrolled 795, 717 and 797 participants, respectively, with active RA and an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs).
Participants received 5 mg of tofacitinib twice daily or a placebo in combination with conventional synthetic DMARDs. The ORAL Standard trial additionally featured an active comparator arm, with 40 mg of adalimumab administered every 2 weeks. Participants receiving placebo were switched to tofacitinib if they failed to achieve at least 20% improvement in swollen and tender joint counts after 3 months. After 6 months, all remaining placebo patients were switched to tofacitinib.
For their own study, Strand and colleagues used subgroup analysis from 2-by-2 tables to examine links between PtGA, pain, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 3 months. Associations between patient-reported outcomes were also examined in participants who had not been treated with conventional synthetic DMARDs, as well as those who had an inadequate response to biologic DMARDs.
According to the researchers, among patients with an inadequate response to conventional synthetic DMARDs, low disease activity, in addition to moderate and substantial improvements in PtGA from baseline, were associated with mild pain, as well as moderate and substantial improvements in pain from baseline. A lack of pain improvement was linked to little or no improvement in PtGA.
Meanwhile, large proportions of participants with an inadequate response to conventional synthetic DMARDs who reported PtGA improvements did not report HAQ-DI or FACIT-F scores at or higher than normal values, nor did they reports changes at or higher than the minimum clinically important difference.
According to Strand and colleagues, PtGA and pain outcomes were moderately-to-strongly correlated at month 3 among participants with an inadequate response to conventional synthetic DMARDs, with weaker links between PtGA and HAQ-DI or FACIT-F outcomes. Similar outcomes were reported among participants who had not been treated with conventional synthetic DMARDs and those who had an inadequate response to biologic DMARDs.
“For the first time, this post hoc analysis of pooled data from three phase 3 RCTs of csDMARD-IR RA patients demonstrates the associations between PtGA and pain, physical function and fatigue in tofacitinib-treated patients, corroborating the importance of clinically meaningful improvements in PROs and attainment of LDA states for the optimization of patient care,” Strand and colleagues wrote. “Similar findings were generally seen in csDMARD-naïve and bDMARD-IR patients.”
“Overall, the findings support the importance of PtGA in clinical practice, and the role of pain, and, to a lesser extent, physical function and fatigue, in driving patients’ perceptions of disease activity,” they added. “While PtGA remains one of the most widely reported PROs, RAPID-3 represents a time-efficient approach that collects three outcomes (PtGA, Pain, and HAQ-DI) and may be supplemented by the addition of a single fatigue measure to provide a more robust picture of patient wellbeing.”
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