Sustained remission with etanercept tapering in early rheumatoid arthritis

Paul Emery, Mohammed Hammoudeh, Oliver FitzGerald, Bernard Combe, Emilio Martin-Mola, Maya H Buch, Marek Krogulec, Theresa Williams, Stefanie Gaylord, Ronald Pedersen, Jack Bukowski, Bonnie Vlahos

Research output: Contribution to journalArticlepeer-review


BACKGROUND: We assessed the effects of reduction and withdrawal of treatment in patients with rheumatoid arthritis who had a remission while receiving etanercept-plus-methotrexate therapy.

METHODS: Patients with early active disease who had not previously received methotrexate or biologic therapy received 50 mg of etanercept plus methotrexate weekly for 52 weeks (open-label phase). We then randomly assigned patients who had qualifying responses at weeks 39 and 52 to receive 25 mg of etanercept plus methotrexate (combination-therapy group), methotrexate alone, or placebo for 39 weeks (double-blind phase). Patients who had qualifying responses at week 39 of the double-blind phase had all treatment withdrawn at that time and were followed to week 65 (treatment-withdrawal phase). The primary end point was the proportion of patients with sustained remission in the double-blind phase.

RESULTS: Of 306 patients enrolled, 193 underwent randomization in the double-blind phase; 131 qualified for the treatment-withdrawal phase. More patients in the combination-therapy group than in the methotrexate-alone group or the placebo group met the criterion for the primary end point (40 of 63 [63%] vs. 26 of 65 [40%] and 15 of 65 [23%], respectively; P=0.009 for combination therapy vs. methotrexate alone; P<0.001 for combination therapy vs. placebo). At 65 weeks, 28 patients (44%) who had received combination therapy, 19 (29%) who had received methotrexate alone, and 15 (23%) who had received placebo were in remission (P=0.10 for combination therapy vs. methotrexate alone; P=0.02 for combination therapy vs. placebo; P=0.55 for methotrexate alone vs. placebo). No significant between-group differences were observed in radiographic progression of disease. Serious adverse events were reported in 3 patients (5%) in the combination-therapy group, 2 (3%) in the methotrexate-alone group, and 2 (3%) in the placebo group.

CONCLUSIONS: In patients with early rheumatoid arthritis who had a remission while receiving full-dose etanercept-plus-methotrexate therapy, continuing combination therapy at a reduced dose resulted in better disease control than switching to methotrexate alone or placebo, but no significant difference was observed in radiographic progression. (Funded by Pfizer; number, NCT00913458.).

Original languageEnglish
Pages (from-to)1781-92
Number of pages12
JournalThe New England Journal of Medicine
Issue number19
Publication statusPublished - 6 Nov 2014


  • Adult
  • Aged
  • Antirheumatic Agents/administration & dosage
  • Arthritis, Rheumatoid/drug therapy
  • Double-Blind Method
  • Drug Therapy, Combination
  • Etanercept
  • Female
  • Humans
  • Immunoglobulin G/administration & dosage
  • Infection/etiology
  • Male
  • Methotrexate/administration & dosage
  • Middle Aged
  • Receptors, Tumor Necrosis Factor/administration & dosage
  • Remission Induction
  • Withholding Treatment


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