Maintenance, reduction, or withdrawal of etanercept in RA

Smolen JS, et al. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial Lancet. 2013 Mar 16;381(9870):918-29. doi: 10.1016/S0140-6736(12)61811-X. Epub 2013 Jan 17.

Many patients will ask how long they need to continue taking certain medications. The PRESERVE trial is the first RCT looking at reduction or withdrawl of TNF inhibitors in RA.

This study is 52-week extension of an initial 36-week open-label trial of methotrexate plus etanercept 50mg weekly, and included only those patients who achieved sustained low disease activity.

participants were eligible for randomisation when they had completed the open-label stage (36 weeks) and achieved sustained low disease activity (mean DAS28 ≤3·2 from weeks 12 to 36 and DAS28 ≤3·2 at week 36).

604 patients were randomized 1:1:1: to:

  • 50 mg etanercept plus methotrexate
  • 25 mg etanercept plus methotrexate
  • Placebo injection plus methotrexate

The primary endpoint was the proportion of patients with low disease activity at week 88

Percentage of patients acheiving primary endpoint:

  • 50 mg etanercept + MTX: 82·6%
  • 25 mg etanercept + MTX: 79·1%
  • Placebo + MTX: 42·6%

No differences were noted in adverse events, specifically infections.

After acheiving remission, it appears that reducing the dose of etanercept to 25mg weekly is a viable option, and as the authors point out, potentially an economical option as well.