TY - JOUR
T1 - Impact of Stopping Tumor Necrosis Factor-inhibitors on Rheumatoid Arthritis Patients' Burden of Disease
AU - Ghiti Moghadam, Marjan
AU - ten Klooster, Peter M.
AU - Vonkeman, Harald E.
AU - Kneepkens, Eva L.
AU - Klaasen, Ruth
AU - Stolk, Jan N.
AU - Tchetverikov, Ilja
AU - Vreugdenhil, Simone A.
AU - van Woerkom, Jan M.
AU - Goekoop-Ruiterman, Yvonne P. M.
AU - Landewé, Robert B. M.
AU - van Riel, Piet L. C. M.
AU - van de Laar, Mart A. F. J.
AU - Jansen, Tim L.
PY - 2018
Y1 - 2018
N2 - To determine the impact of stopping tumor necrosis factor inhibitor (TNFi) treatment on patient-reported outcomes (PROs) of physical and mental health status, health utility, pain, disability and fatigue in patients with established rheumatoid arthritis (RA). 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 TNFi. In case of flare, TNFi was restarted at the discretion of the rheumatologist. PROs were assessed every 3 months. TNFi was restarted within 12 months in 252/531 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 minimal clinically important difference (MCID) on all PROs. 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 a MCID ranged from 1.16 for mental health status to 1.58 for fatigue. Mean PRO scores for patients restarting TNFi within 6 months were no longer significantly different from those that did not restart TNFi at 12 months. Stopping TNFi had a significant negative short-term impact on a broad range of PROs. Long-term negative consequences appeared to be limited and outcomes in patients needing to restart TNFi within the first 6 months tended to be restored at 12 months. This article is protected by copyright. All rights reserved
AB - To determine the impact of stopping tumor necrosis factor inhibitor (TNFi) treatment on patient-reported outcomes (PROs) of physical and mental health status, health utility, pain, disability and fatigue in patients with established rheumatoid arthritis (RA). 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 TNFi. In case of flare, TNFi was restarted at the discretion of the rheumatologist. PROs were assessed every 3 months. TNFi was restarted within 12 months in 252/531 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 minimal clinically important difference (MCID) on all PROs. 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 a MCID ranged from 1.16 for mental health status to 1.58 for fatigue. Mean PRO scores for patients restarting TNFi within 6 months were no longer significantly different from those that did not restart TNFi at 12 months. Stopping TNFi had a significant negative short-term impact on a broad range of PROs. Long-term negative consequences appeared to be limited and outcomes in patients needing to restart TNFi within the first 6 months tended to be restored at 12 months. This article is protected by copyright. All rights reserved
U2 - https://doi.org/10.1002/acr.23315
DO - https://doi.org/10.1002/acr.23315
M3 - Article
C2 - 28692770
SN - 2151-464X
VL - 70
SP - 516
EP - 524
JO - Arthritis care & research
JF - Arthritis care & research
IS - 4
ER -