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Impact of Stopping Tumor Necrosis Factor Inhibitors on Rheumatoid Arthritis Patients’ Burden of Disease
Author(s) -
Ghiti Moghadam Marjan,
Klooster Peter M.,
Vonkeman Harald E.,
Kneepkens Eva L.,
Klaasen Ruth,
Stolk Jan N.,
Tchetverikov Ilja,
Vreugdenhil Simone A.,
Woerkom Jan M.,
GoekoopRuiterman Yvonne P. M.,
Landewé Robert B. M.,
Riel Piet L. C. M.,
Laar Mart A. F. J.,
Jansen Tim L.
Publication year - 2018
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.23315
Subject(s) - medicine , rheumatoid arthritis , minimal clinically important difference , physical therapy , tumor necrosis factor alpha , randomized controlled trial , tumor necrosis factor α , discontinuation , surgery
Objective To determine the impact of stopping tumor necrosis factor inhibitor ( TNF i) treatment on patient‐reported outcomes ( PRO s) of physical and mental health status, health utility, pain, disability, and fatigue in patients with established rheumatoid arthritis ( RA ). Methods In the pragmatic, 12‐month POET trial, 817 RA patients with ≥6 months of remission or stable low disease activity were randomized 2:1 to stopping or continuing TNF i. In case of flare, TNF i was restarted at the discretion of the rheumatologist. PRO s were assessed every 3 months. Results TNF i was restarted within 12 months in 252 of 531 patients (47.5%) in the stop group. At 3 months, mean PRO scores were significantly worse in the stop group, and a larger proportion of patients experienced a minimum clinically important difference ( MCID ) on all PRO s. Effect sizes ( ES ) were strongest for health utility ( ES −0.24) and pain ( ES −0.30). Mean scores improved again after this point, but disability scores remained significantly different at 12 months. After 12 months, the relative risk of experiencing an MCID ranged from 1.16 for mental health status to 1.58 for fatigue. Mean PRO scores for patients restarting TNF i within 6 months were no longer significantly different from those that did not restart TNF i at 12 months. Conclusion Stopping TNF i had a significant negative short‐term impact on a broad range of PRO s. Long‐term negative consequences appeared to be limited, and outcomes in patients needing to restart TNF i within the first 6 months tended to be restored at 12 months.