Impact of Stopping Tumor Necrosis Factor-inhibitors on Rheumatoid Arthritis Patients' Burden of Disease.
Arthritis Care Res (Hoboken). 2017 Jul 10;:
Authors: Ghiti Moghadam M, Ten Klooster PM, Vonkeman HE, Kneepkens EL, Klaasen R, Stolk JN, Tchetverikov I, Vreugdenhil SA, van Woerkom JM, Goekoop-Ruiterman YPM, Landewé RBM, van Riel PLCM, van de Laar MAFJ, Jansen TL, Dutch National POET Collaboration
Abstract
OBJECTIVE: 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).
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 TNFi. In case of flare, TNFi was restarted at the discretion of the rheumatologist. PROs were assessed every 3 months.
RESULTS: 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.
CONCLUSION: 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.
PMID: 28692770 [PubMed - as supplied by publisher]
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