medwireNews: Patients with rheumatoid arthritis (RA) who stop tumor necrosis factor (TNF) inhibitor therapy experience worse patient-reported outcomes (PROs) in the short-term than those who continue treatment, analysis of trial data suggests.
The previously reported primary outcomes of the open-label POET trial showed that participants with stable disease who were randomly assigned to stop TNF inhibitor therapy while continuing treatment with conventional disease-modifying antirheumatic drugs had “substantially more clinical flares” than those assigned to continue TNF inhibitor treatment. But “most patients who restarted [TNF inhibitor] treatment quickly regained remission or low disease activity,” say Marjan Ghiti Moghadam (University Hospital Leuven, Belgium) and study co-authors.
“The current study extends these findings by demonstrating that stopping [TNF inhibitor treatment] also had a significant, but small, short-term negative impact on patient-reported physical and mental health status, health utility, pain, disability and fatigue,” they add.
The team found that after 3 months of follow-up, the 531 participants who stopped TNF inhibitor treatment had significantly worse scores on the 36-item short-form (SF-36) physical component survey and the SF-36 mental component survey (MCS) than those in the continuation group (approximately 43 versus 45 and 51 versus 53 points, respectively).
Patients who stopped treatment also had significantly worse scores on bodily pain, quality of life, and fatigue indices after 3 months of follow-up.
And a larger proportion of participants in the stopping group experienced a clinically important worsening in all PROs at 3 months, with relative risks with stopping versus continuing treatment ranging from 1.63 for quality of life scores and 2.19 for SF-36-MCS scores.
Mean PRO scores improved after 3 months, and the majority of scores were not significantly different between the stopping and continuation groups at the 12-month follow-up. However, disability scores in the two groups remained significantly worse in the stopping group at 12 months, at approximately 0.7 versus 0.6 points.
In all, 39.7% of patients in the stopping group restarted TNF inhibitor therapy at the discretion of their rheumatologist by month 6, with 47.5% restarting treatment over 12 months. PRO scores “improved rapidly” after restarting therapy, and were not significantly different between patients restarting within 6 months and those who did not restart TNF inhibitors at all after 9 months.
These findings suggest that a strategy of stopping TNF inhibitor treatment “does not appear to have substantial long-term consequences for the burden of disease as experienced by patients,” write the researchers in Arthritis Care & Research.
However, they note that because “rheumatologists were free to prescribe and adjust medications as considered clinically necessary […], it is not possible to attribute the differences between groups purely to the effects of stopping [TNF inhibitor treatment] and the impact on PRO scores may be substantially confounded by other treatment decisions.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group