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- W1972498376 abstract "BackgroundRheumatoid arthritis (RA) is an immunologically drivenchronic condition characterized not only by persistent jointinflammation (synovitis) but also by systemic inflammation[1].Uncontrolled active RA produces disability and areduction of the health-related quality of life that result inloss of work and high medical and social costs [2]. Theimpact of RA on patients and society justifies treatmentwith biologics [2], expensive drugs that are not free fromcomplications and adverse events, even severe [3].The target of treatment in RA is achievement of lowdisease activity or remission [4]. It is yet to be clarifiedwhether low disease activity or remission can be alsosustained, not only by maintaining the recommendedtherapy but also by reducing or discontinuing the biologictreatment. In fact, a reduction or withdrawal of suchtreatment could imply a great amount of financial savingfor the National Health Systems.Although there are many observational studies regardingwithdrawal of anti-TNF-alpha after a period of induction,evidence coming from randomized clinical trials is stilllacking.SummaryIn a randomized controlled trial, Smolen et al. [5] assessedwhether the response to conventional doses of biologicsand background methotrexate in patients with moderatelyactive disease would be sustained after etanercept reduc-tion or withdrawal. Patients aged between 18 and 70 withmoderate disease activity, defined as a disease activityscore on 28 joints (DAS28) value between 3.2 and 5.1despite treatment with methotrexate were enrolled andgiven 50 mg etanercept plus methotrexate every weekduring an open label period of 36 weeks. Patients whocompleted the open label stage and achieved a sustainedlow disease activity (DAS283.2) were considered eli-gible for a subsequent double-blind period of 52 weeks.They were randomized in a 1:1:1 ratio to a weekly sub-cutaneous injection of 50 mg of etanercept plus metho-trexate, 25 mg of etanercept plus methotrexate oretanercept placebo plus methotrexate.The primary endpoint was the proportion of patients atweek 88 with a low disease activity (DAS28 B 3.2) in thegroups given 50 mg of etanercept and etanercept placeboin the double-blind period. If low disease activity wasmaintained significantly more frequently when 50 mg e-tanercept was continued than with placebo, a conditionalprimary endpoint was the proportion of patients receiving25 mg etanercept who achieved low disease activity. Aconditional endpoint was the proportion of patientsreceiving 25 mg of etanercept who maintained a low dis-ease activity. Secondary endpoints were remission basedon DAS28 (2.6) and remission based on simplified dis-ease activity index criteria (B3.3).Out of the 834 enrolled patients, 604 were eligible forthe double-blind period: 202 were assigned to 50 mg eta-nercept plus methotrexate, 202 to 25 mg of etanercept plus" @default.
- W1972498376 created "2016-06-24" @default.
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- W1972498376 date "2013-12-05" @default.
- W1972498376 modified "2023-09-27" @default.
- W1972498376 title "Is it safe to withdraw etanercept in established rheumatoid arthritis after low disease activity achievement?" @default.
- W1972498376 cites W1761300068 @default.
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- W1972498376 doi "https://doi.org/10.1007/s11739-013-1024-9" @default.
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