Sustained remission with methotrexate monotherapy after 22-week induction treatment with TNF-alpha inhibitor and methotrexate in early psoriatic arthritis: an open-label extension of a randomized placebo-controlled trial

Arthritis Res Ther. 2019 Sep 14;21(1):208. doi: 10.1186/s13075-019-1998-4.


Background: If TNF inhibitors are initiated in the early stages of psoriatic arthritis, this could potentially modulate disease and therefore allow us to discontinue the TNF inhibitor after achieving remission.

Objective: To investigate whether remission induced by tumour necrosis factor alpha inhibitor (TNFi) and methotrexate in patients with early psoriatic arthritis is sustained after withdrawal of TNFi.

Methods: Open-label extension of a recently published double-blind, randomized placebo-controlled trial. Patients with psoriatic arthritis fulfilling the CASPAR criteria and with active disease at baseline (swollen and tender joint count ≥ 3) were randomized to either golimumab and methotrexate or matched placebo and methotrexate. Patients in Disease Activity Score (DAS) remission at week 22 continued in the open-label extension on methotrexate monotherapy. The primary end point was the percentage of patients in DAS-CRP remission (DAS < 1.6) at week 50.

Results: Eight patients from the original placebo group and 18 patients from the original TNFi group continued in the extension phase. At week 50, 6 out of 8 (75%) patients from the original MTX (methotrexate) group versus 10 out of 18 (56%) patients from the original MTX+TNFi group were in DAS-CRP remission (p = 0.347). Considering the total study population, 6 out of 24 (25%) of the original MTX group versus 10 out of 26 (38.5%) of the original MTX+TNFi group were in DAS remission at week 50 (p = 0.308).

Conclusions: Remission achieved by initial combination treatment with TNFi and methotrexate in early psoriatic arthritis is maintained on methotrexate monotherapy in approximately half of the patients.

Trial registration: Registered at with number NCT01871649 on June 7, 2013.

Keywords: Early psoriatic arthritis; Methotrexate; Remission; TNF inhibitor; Treatment withdrawal.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal / administration & dosage*
  • Antirheumatic Agents / administration & dosage
  • Arthritis, Psoriatic / diagnosis
  • Arthritis, Psoriatic / drug therapy*
  • Disease Progression
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Methotrexate / administration & dosage*
  • Middle Aged
  • Remission Induction / methods*
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor Inhibitors / therapeutic use*


  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Tumor Necrosis Factor Inhibitors
  • golimumab
  • Methotrexate

Associated data